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Guidance for Industry

Listed Drugs, 30-Month Stays, and 

Approval of ANDAs and

 505(b)(2) Applications Under 

Hatch-Waxman, as Amended by the 

Medicare Prescription Drug, 

Improvement, and Modernization Act 

of 2003

Questions and Answers

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the 

Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division 

of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 

20852. All comments should be identified with the docket number listed in the notice of availability that publishes 

in the Federal Register.

For questions regarding this draft document, contact Martin Shimer, 301-827-5710.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

October 2004

OGD
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10/13/04

Guidance for Industry

Listed Drugs, 30-Month Stays, and 

Approval of ANDAs and

 505(b)(2) Applications Under 

Hatch-Waxman, as Amended by the 

Medicare Prescription Drug, 

Improvement, and Modernization Act 

of 2003

Questions and Answers

Additional copies are available from:

Office of Training and Communications

Division of Drug Information, HFD-240

Center for Drug Evaluation and Research

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

(Tel) 301-827-4573

http://www.fda.gov/cder/guidance/index.htm

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

October 2004

OGD
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TABLE OF CONTENTS

I. INTRODUCTION..................................................................................................................................................1

II. QUESTIONS AND ANSWERS...........................................................................................................................2

A. Listed Drug.............................................................................................................................................................2

B. Role of Court Decisions and Other Judicial Action.............................................................................................3

C. Notice of Paragraph IV Certifications..................................................................................................................6

D. Multiple 30-Month Stays.......................................................................................................................................8

E. 180-Day Exclusivity............................................................................................................................................ 10

F. Applicability and Effective Dates...................................................................................................................... 11
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Guidance for Industry11

2 Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) 

3 Applications Under Hatch-Waxman, as Amended by the Medicare 

4 Prescription Drug, Improvement, and Modernization Act of 2003

5

6 Questions and Answers

7

8

9

10 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) 

11 current thinking on this topic. It does not create or confer any rights for or on any person and 

12 does not operate to bind FDA or the public. You can use an alternative approach if the approach 

13 satisfies the requirements of the applicable statutes and regulations. If you want to discuss an 

14 alternative approach, contact the FDA staff responsible for implementing this guidance. If you 

15 cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of 

16 this guidance. 

17

18 I. INTRODUCTION

19

20 On December 8, 2003, President Bush signed into law the Medicare Prescription Drug, 

21 Improvement, and Modernization Act of 2003 (Public Law 108-173) (MMA). Title XI 

22 of the MMA amends sections 505(b), (c), and (j) of the Federal Food, Drug, and

23 Cosmetic Act (the Act) (21 U.S.C. 355(b), (c), and (j)). Among other things, the MMA 

24 directs FDA to issue guidance defining the term listed drug with respect to amendments 

25 and supplements to abbreviated new drug applications (ANDAs). This guidance is 

26 intended to clarify when a change to an ANDA should reference a listed drug different

27 from the drug referenced in the original ANDA, thus requiring the change to be made 

28 through an entirely new application. As directed by the MMA, this document (in the 

29 form of questions and answers) provides guidance on the definition of listed drug. 

30

Further, as indicated in our March 3, 2004, Federal Register notice,231 we have been 

32 considering what other steps we should take in light of the MMA. As one such step, this 

33 document provides guidance to industry on certain sections of the MMA that 

34 significantly change provisions of the Act that were originally added by the Drug Price 

35 Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (Hatch36 Waxman). These changes relate, in substantial part, to 30-month stays and to the timing 

37 of approval of ANDAs and new drug applications (NDAs) described in section 505(b)(2) 

38 of the Act (505(b)(2) applications). Specifically, this guidance clarifies changes made by 

39 the MMA with respect to (1) the availability and termination of 30-month stays of 

 

1

 This guidance has been prepared by the Office of Generic Drugs (OGD) in the Center for Drug 

Evaluation and Research (CDER) in cooperation with the Office of Regulatory Policy (ORP) and the 

Office of the Chief Counsel (OCC) at the Food and Drug Administration.

2

 See Generic Drug Issues; Request for Comments (69 FR 9982).
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40 approval on ANDAs and 505(b)(2) applications under section 505(j)(5)(B)(iii) and 

41 505(c)(3)(C) of the Act, respectively, and (2) requirements for notice of patent 

42 certifications described in sections 505(b)(2)(A)(iv) and 505(j)(2)(A)(vii)(IV) of the Act 

43 (paragraph IV certifications). It also clarifies the applicability of certain changes made 

44 by the MMA regarding the period during which ANDAs that were not the first to

45 challenge a patent on the listed drug cannot be approved (180-day exclusivity), as 

46 described in section 505(j)(5)(B)(iv) of the Act. Finally, this guidance explains the 

47 various effective dates that apply to the MMA’s provisions.

48

49 FDA's guidance documents, including this guidance, do not establish legally enforceable 

50 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and 

51 should be viewed only as recommendations, unless specific regulatory or statutory 

52 requirements are cited. The use of the word should in Agency guidances means that 

53 something is suggested or recommended, but not required. 

54

55 II. QUESTIONS AND ANSWERS

56

57 A. Listed Drug

58

59 1. Why is a guidance needed on the definition of listed drug?

60

61 The MMA, among other things, generally prohibits an ANDA applicant from amending 

62 or supplementing its application to refer to a listed drug which is different from that 

63 referred to in the application when originally submitted. Such a change can be made only 

64 by the submission of an entirely new application.

65

66 Title XI of the MMA states in part that the Secretary will issue guidance defining the 

67 term listed drug for purposes of section 1101(a)(1)(B) of the MMA. That section, which 

68 is now section 505(j)(2)(D)(i) of the Act, provides that “[a]n applicant may not amend or 

69 supplement an [ANDA] to seek approval of a drug referring to a different listed drug 

from the listed drug identified in the application as submitted to the Secretary."370 FDA's 

definition of listed drug is contained in § 314.3 (21 CFR 314.3).471 The Agency does not 

72 intend to amend that definition.

 

3

 The MMA added a related provision to the Act with respect to 505(b)(2) applications: “An applicant may 

not amend or supplement [a 505(b)(2) application] to seek approval of a drug that is a different drug than 

the drug identified in the application as submitted to the Secretary” (section 505(b)(4)(A) of the Act). This 

guidance does not pertain to the foregoing provision on 505(b)(2) applications because that provision does 

not use the term listed drug, and the MMA only directs FDA to issue guidance with respect to the provision 

applicable to 505(j) applications.

4

 This definition reads:

Listed drug means a new drug product that has an effective approval under section 505(c) of the [A]ct for 

safety and effectiveness or under section 505(j) of the [A]ct, which has not been withdrawn or suspended under 

section 505(e)(1) through (e)(5) or (j)(5) of the [A]ct, and which has not been withdrawn from sale for what 

FDA has determined are reasons of safety or effectiveness. Listed drug status is evidenced by the drug 

product’s identification as a drug with an effective approval in the current edition of FDA’s “Approved Drug 

Products with Therapeutic Equivalence Evaluations” [commonly referred to as the Orange Book] or any current 

supplement thereto.... A drug product is deemed to be a listed drug on the date of effective approval of the 

application or abbreviated application for that drug product (21 CFR 314.3(b)).
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73

74 2. Generally, when should a separate ANDA be submitted for a different listed 

75 drug?

76

77 The appropriate choice of whether to submit a new ANDA for a proposed product — as 

78 opposed to submitting an amendment or supplement to a previously submitted or already 

79 approved ANDA — is governed by a number of considerations. All changes that would 

80 have the effect of seeking approval for a drug product different from the listed drug cited 

81 in the initial submission (e.g., different active ingredient, dosage form, route of 

82 administration) should be made in a new application. When the Orange Book identifies 

83 as a separate listed drug a product with the characteristics (e.g., active ingredient, dosage 

84 form, route of administration) for which the applicant is seeking approval, the applicant 

should submit a separate ANDA referencing the corresponding listed drug. 585 The 

86 applicant should not submit a supplement or amendment to its pending or approved 

87 application to seek approval for such a change.

88 

89 3. Can an amendment or supplement be submitted for different strengths?

90

91 Each strength of an approved drug is a separate listed drug. Each strength proposed in an 

92 ANDA should reference the corresponding listed drug (although the reference standard 

93 for purposes of bioequivalence may be only one strength). Generally, a single 

94 application can be used to seek approval for different strengths of the same listed drug. 

95 Also, an applicant may submit an amendment or supplement to seek approval of a 

96 different strength from that for which the application was initially submitted and is not 

97 required to file a separate application for such a change. This is expressly permitted 

98 under the Act, as amended by the MMA (see section 505(j)(2)(D)(ii) of the Act, as 

99 amended). 

100

101 B. Role of Court Decisions and Other Judicial Action

102

103 1. What court decisions and other judicial actions are relevant for lifting 30-

104 month stays of approval on ANDAs and 505(b)(2) applications? 

105

106 Hatch-Waxman amended the Act to establish up to a 30-month stay of approval on an 

107 ANDA or 505(b)(2) application if:

108

109 • The application includes a paragraph IV certification challenging a patent 

110 listed in the Orange Book (a listed patent) that claims the approved drug 

111 (listed drug) on which the ANDA or 505(b)(2) application relies or claims 

112 the use of the listed drug, and 

113

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5

 Separate approved drug products, other than products with different strengths, will ordinarily have 

different NDA numbers.
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114 • The patent owner or NDA holder for the listed drug sues the ANDA or 

115 505(b)(2) applicant for patent infringement within 45 days of receiving 

116 notice of the paragraph IV certification. 

117

118 The 30-month stay may be shortened or lengthened by the court if “either party to the 

action fail[s] to reasonably cooperate in expediting the action.”6119 

120

121 The MMA further amends the Act to specify what actions by what courts will terminate a 

122 30-month stay of approval. (The MMA also amends the Act to alter the circumstances 

123 under which a 30-month stay can arise, as discussed below in questions 1 and 2 in 

124 subsection II.D of this document.) The provisions of the MMA that identify the relevant 

125 court actions apply to any proceeding under section 505 of the Act that is pending on or 

after December 8, 2003.7126 Under the MMA, a 30-month stay will be terminated and 

127 approval of an ANDA or 505(b)(2) application may be made effective, as of any of the 

128 following:

129

130 • The date that the district court enters judgment reflecting its decision 

131 that the patent at issue is invalid or not infringed (including any 

132 substantive determination that there is no cause of action for patent 

infringement or invalidity), 8133 or

134

135 • The date of a settlement order or consent decree signed and entered 

136 by the district court stating that the patent that is the subject of the 

certification is invalid or not infringed, 9137 or

138

139 • If the district court decides that the patent has been infringed, and this 

140 decision is reversed on appeal, the date on which the court of appeals 

141 decides that the patent is invalid or not infringed (including any 

142 substantive determination that there is no cause of action for patent 

infringement or invalidity),10 143 or the date of a settlement order or 

144 consent decree signed and entered by the court of appeals stating that 

 

6

 Section 505(c)(3)(C) and 505(j)(5)(B)(iii) of the Act.

7

 See MMA Title XI section 1101(c)(1).

8

 See MMA Title XI section 1101(a)(2)(A)(ii)(II)(aa) and 1101(b)(2)(B)(ii)(II) (creating new section 

505(j)(5)(B)(iii)(I)(aa) and 505(c)(3)(C)(i)(I) of the Act, respectively); see also MMA Title XI section 

1101(a)(2)(A)(ii)(II)(cc) and 1101(b)(2)(B)(ii)(IV) (amending section 505(j)(5)(B)(iii)(III) and 

505(c)(3)(C)(iii) of the Act, respectively).

9

 See MMA Title XI section 1101(a)(2)(A)(ii)(II)(aa) and 1101(b)(2)(B)(ii)(II) (creating new section 

505(j)(5)(B)(iii)(I)(bb) and 505(c)(3)(C)(i)(II) of the Act, respectively); see also MMA Title XI section 

1101(a)(2)(A)(ii)(II)(cc) and 1101(b)(2)(B)(ii)(IV) (amending section 505(j)(5)(B)(iii)(III) and 

505(c)(3)(C)(iii) of the Act, respectively).

10 See MMA Title XI section 1101(a)(2)(A)(ii)(II)(bb) and 1101(b)(2)(B)(ii)(III) (creating new section 

505(j)(5)(B)(iii)(II)(aa)(AA) and 505(c)(3)(C)(ii)(I)(aa) of the Act, respectively); see also MMA Title XI 

section 1101(a)(2)(A)(ii)(II)(dd) and 1101(b)(2)(B)(ii)(V) (creating new section 505(j)(5)(B)(iii)(IV) and 

505(c)(3)(C)(iv) of the Act, respectively).
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145 the patent that is the subject of the certification is invalid or not 

infringed.11 146

147

148 If the district court hearing a patent infringement suit resulting from a paragraph IV 

149 certification decides that the patent at issue is infringed, and this decision is not appealed 

150 or is affirmed on appeal, the ANDA or 505(b)(2) application may be approved based on 

151 the district court’s ruling in accordance with the patent’s expiration and any extension or 

exclusivity that remains.12 152

153

154 2. What court decisions are relevant for triggering 180-day exclusivity for 

155 ANDAs?

156

157 As established by Hatch-Waxman, if an applicant (or applicants) is the first to submit a 

158 substantially complete ANDA containing a paragraph IV certification to a listed patent 

159 that claims the listed drug on which the application relies or claims a use of the listed 

160 drug (a paragraph IV ANDA), the applicant (or applicants) can be eligible for a 180-day 

161 period during which no other ANDA with a paragraph IV certification for the same drug 

may be approved.13 This period is commonly referred to as 180-day exclusivity.

14 162 Under 

163 Hatch-Waxman before the MMA, the 180-day exclusivity period was triggered by the 

164 earlier of the first commercial marketing of the drug described in the first applicant’s 

165 ANDA, or the first court decision holding invalid or not infringed the patent that was the 

subject of the first applicant’s paragraph IV certification. 15 166

167

168 The MMA changes the relevance of court decisions for 180-day exclusivity in the 

169 following ways:

170

171 • For paragraph IV ANDAs filed after December 8, 2003, for a listed drug 

172 for which no paragraph IV certification was made in any ANDA before 

173 that date, court decisions will no longer trigger the period of 180-day 

174 exclusivity; and

175

176 • For all other ANDAs, a court decision can still trigger the period of 

177 180-day exclusivity. However, if the exclusivity was not already 

178 triggered before December 8, 2003, the triggering court decision must 

179 be one from which no appeal has been or can be taken, other than a 

 

11 See MMA Title XI section 1101(a)(2)(A)(ii)(II)(bb) and 1101(b)(2)(B)(ii)(III) (creating new section 

505(j)(5)(B)(iii)(II)(aa)(BB) and 505(c)(3)(C)(ii)(I)(bb) of the Act, respectively); see also MMA Title XI 

section 1101(a)(2)(A)(ii)(II)(dd) and 1101(b)(2)(B)(ii)(V) (creating new section 505(j)(5)(B)(iii)(IV) and 

505(c)(3)(C)(iv) of the Act, respectively). 

12 See MMA Title XI section 1101(a)(2)(A)(ii)(II)(bb) and 1102(b)(2)(B)(ii)(III) (creating new section 

505(j)(5)(B)(iii)(II)(bb) and 505(c)(3)(C)(ii)(II) of the Act, respectively); see also MMA Title XI section 

1101(a)(2)(A)(ii)(II)(dd) and 1101(b)(2)(B)(ii)(V) (creating new section 505(j)(5)(B)(iii)(IV) and 

505(c)(3)(C)(iv) of the Act, respectively).

13 See section 505(j)(5)(B)(iv) of the Act. 

14 505(b)(2) applications do not qualify for 180-day exclusivity.

15 See section 505(j)(5)(B)(iv) of the Act; Mylan Pharmaceuticals, Inc. v. Shalala, 81 F. Supp. 2d 30 

(D.D.C. 2000).
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180 petition to the Supreme Court for a writ of certiorari (generally a decision 

of an appellate court).16 181 (This is a transitional provision that redefines the 

182 court decision that can begin the 180-day period of exclusivity for any 

183 product for which there was a paragraph IV ANDA before enactment of 

184 the MMA.)

185

186 3. An ANDA was submitted on September 6, 2003, and was the first 

187 substantially complete ANDA to be submitted with a paragraph IV 

188 certification to the only listed patent for the listed drug. The ANDA 

189 applicant is sued for patent infringement. After December 8, 2003, the 

190 district court issues a decision finding the patent at issue invalid. This 

191 decision is appealed. Can the ANDA be approved? Does the applicant’s 180-

192 day exclusivity start to run on the date of the district court’s decision? 

193

194 As explained in the response to question 1 in subsection II.B of this document, for any 

195 proceeding under section 505 of the Act pending on or after December 8, 2003, the 

196 district court’s decision that the patent at issue is invalid or not infringed terminates the 

197 30-month stay of approval. Thus, if it is otherwise ready for approval, the ANDA in this 

198 question can be approved at the time of the district court’s decision. However, as 

199 explained in response to question 2 in subsection II.B, as a result of the MMA, 180-day 

200 exclusivity for ANDAs filed before December 8, 2003, can now be triggered by a court 

201 decision only if it is a decision that has not been, or cannot be, appealed. Therefore, the 

202 district court’s decision does not trigger 180-day exclusivity in the scenario described in 

203 this question because that decision has been appealed. Note that this result is a departure 

204 from prior law. Before enactment of the MMA, a district court decision finding a listed 

205 patent invalid or not infringed would have both terminated a 30-month stay and, in the 

206 case of an ANDA that qualified for 180-day exclusivity, triggered the start of such 

207 exclusivity as to that patent (if the exclusivity was not already triggered by commercial 

208 marketing).

209

210 4. What is the status of FDA’s guidance for industry entitled Court Decisions, 

211 ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman 

212 Amendments to the Federal Food, Drug, and Cosmetic Act?

213

214 That guidance addresses the types of court decisions relevant for ANDA approvals and 

215 180-day exclusivity under Hatch-Waxman before enactment of the MMA. The MMA 

216 supersedes relevant provisions of Hatch-Waxman in effect at the time that guidance was 

217 published and thus supersedes the guidance. 

218

219 C. Notice of Paragraph IV Certifications

220

221 1. Are ANDA and 505(b)(2) applicants required to give notice for paragraph IV 

222 certifications made between August 18, 2003, and December 8, 2003? 

 

16 See MMA Title XI section 1102(b)(3) (defining, for this purpose, decision of a court as used in section 

505(j)(5)(B)(iv) of the Act).
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223

224 Yes. The MMA requires ANDA and 505(b)(2) applicants to provide notice for all

paragraph IV certifications submitted to FDA on or after August 18, 2003.17 225 Notice is to 

226 be provided: 

227

228 • If the certification is included in the original application, not later than 20 

229 days after the date of the postmark on the notice from FDA informing the 

230 applicant that the application has been filed, or

231

232 • If the certification is in an amendment or supplement, at the time the 

233 applicant submits the amendment or supplement, regardless of whether the 

234 applicant has already given notice of a prior paragraph IV certification 

235 contained in the application or an amendment or supplement to the 

application.18 236

237

238 We recognize that our final rule which became effective on August 18, 2003 (Final 

Rule),19 239 stated that notice was not required for a paragraph IV certification made by an 

240 ANDA or 505(b)(2) applicant if the applicant had already provided notice of another 

241 paragraph IV certification in its application or an amendment or supplement to the 

242 application. However, as discussed above, the MMA’s provisions regarding notice are 

243 retroactive to August 18, 2003, and supersede the Final Rule’s provisions concerning this 

subject. On March 10, 2004, FDA revoked the Final Rule’s notice-related provisions.20 244

245

246 We are also aware that compliance with the MMA’s time frame for providing notice of a 

247 paragraph IV certification made in an amendment to an ANDA or 505(b)(2) application 

248 is not possible for ANDA and 505(b)(2) applicants who submitted paragraph IV 

249 certifications in amendments between August 18, 2003, and December 8, 2003, for which 

250 no notice was required under the Final Rule, and who have not yet provided notice of 

251 these certifications. We emphasize, however, that the MMA’s requirement for notice is 

now in effect for all paragraph IV certifications made on or after August 18, 2003, 21 252

253 including those paragraph IV certifications previously excluded from notice requirements 

254 by the recently revoked provisions of the Final Rule. Accordingly, all applicants with 

255 pending ANDAs or 505(b)(2) applications that include paragraph IV certifications made 

256 on or after August 18, 2003, but before December 8, 2003, should have provided notice 

257 to NDA holders and patent owners in a timely manner.

 

17 See MMA Title XI section 1101(a)(1)(A) and 1101(b)(1)(A) (amending section 505(j)(2)(B)(i) and 

505(b)(3)(A) of the Act, respectively); see also MMA Title XI section 1101(c)(2).

18 See MMA Title XI section 1101(a)(1)(A) and 1101(b)(1)(A) (amending section 505(j)(2)(B)(ii) and 

505(b)(3)(B) of the Act, respectively).

19 See Applications for FDA Approval to Market a New Drug: Patent Submission and Listing 

Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications 

Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed; Final Rule (68 FR 36676; 

June 18, 2003).

20 See Application of 30-Month Stays on Approval of Abbreviated New Drug Applications and Certain 

New Drug Applications Containing a Certification That a Patent Claiming the Drug Is Invalid or Will Not 

Be Infringed; Technical Amendment (69 FR 11309; March 10, 2004).

21 See MMA Title XI section 1101(c)(2).
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258

259 2. If, between August 18, 2003, and December 8, 2003, an ANDA or 505(b)(2) 

260 applicant provided voluntary notice with respect to a paragraph IV 

261 certification for which notice was not required under the Final Rule, is the 

262 applicant considered to have satisfied the MMA’s notice requirement?

263

264 The applicant will have satisfied the MMA’s notice requirement if the notice it gave 

265 complies with all applicable provisions of the MMA (e.g., provisions specifying to whom 

notice must be given and the notice’s required contents). 22 266 

267

268 D. Multiple 30-Month Stays

269

270 1. Does the MMA preclude ANDAs and 505(b)(2) applications from being 

271 subject to more than one 30-month stay of approval?

272

273 The MMA generally precludes multiple 30-month stays for those applications to which it 

274 applies. The relevant provisions of the MMA apply to patents submitted to FDA on or 

after August 18, 2003.23 275 For ANDAs and 505(b)(2) applications with paragraph IV 

276 certifications to a patent submitted to FDA on or after August 18, 2003, the MMA 

277 provides that a 30-month stay may be available for litigation related to that patent only if 

278 the patent was submitted to FDA before the date that the ANDA or 505(b)(2) application 

(excluding an amendment or supplement) was submitted.24 279 In other words, the MMA 

280 precludes 30-month stays for later listed patents, that is, those patents submitted to FDA

281 on or after the date the ANDA or 505(b)(2) application was submitted. Because of this 

282 limitation, in most cases, ANDAs and 505(b)(2) applications will be subject to no more 

than one 30-month stay. 25 283 

284

285 Multiple 30-month stays, however, still may be possible in certain cases. For instance, an 

286 ANDA or 505(b)(2) application may contain a paragraph IV certification to a patent at 

287 the time of first submission that gives rise to one 30-month stay. If the same application 

288 also contains a paragraph III certification to a different patent that was submitted to FDA 

289 (1) on or after August 18, 2003, and (2) before the ANDA or 505(b)(2) application was 

290 submitted, and the applicant subsequently converts this certification to a paragraph IV 

 

22 See MMA Title XI section 1101(a)(1)(A) and 1101(b)(1)(A) (amending section 505(j)(2)(B) and 

505(b)(3) of the Act, respectively).

23 See MMA Title XI section 1101(c)(3). The effective date for this provision means that the MMA 

supersedes FDA’s Final Rule with respect to the availability of 30-month stays. As noted earlier in 

response to question 1 in subsection II.C of this document, on March 10, 2004, FDA revoked provisions of 

the Final Rule superseded by the MMA (see footnote 20, supra). 

24 See MMA Title XI section 1101(a)(2)(A)(ii)(I) and 1101(b)(2)(B)(i) (amending section 505(j)(5)(B)(iii) 

and 505(c)(3)(C) of the Act, respectively).

25 Under the regulations in effect before FDA adopted its August 18, 2003, Final Rule, multiple 30-month 

stays could arise in the case of later-listed patents if (1) an ANDA or 505(b)(2) application had already 

been subject to one such stay based on a paragraph IV certification to a patent listed before the 

application’s submission, and (2) the ANDA or 505(b)(2) applicant made a subsequent paragraph IV 

certification to a patent listed after the application’s submission that triggered another timely patent 

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291 certification, a second 30-month stay could be possible. This is because the new 

292 paragraph IV certification is subject to the MMA and references a patent submitted to 

293 FDA before the applicant’s ANDA was submitted.

294

295 2. Does the MMA ensure that a patent owner or NDA holder can obtain one 30-

296 month stay of approval on an ANDA or 505(b)(2) application containing a 

297 paragraph IV certification to a listed patent when the patent owner or NDA 

298 holder sues the ANDA or 505(b)(2) applicant for patent infringement?

299

300 No. The MMA does not guarantee that any patent owner or NDA holder will receive a 

301 30-month stay, even if it sues for patent infringement. Rather, the MMA provides the 

302 opportunity to obtain a stay only in certain situations. As noted in response to question 1 

303 in subsection II.D of this document, the amendments made by the MMA with respect to 

304 the availability of 30-month stays apply to patents submitted to FDA on or after August 

305 18, 2003. With respect to such patents, a 30-month stay of approval on an ANDA or 

306 505(b)(2) application containing a paragraph IV certification to the patent will ensue if:

307 

308 • The patent was submitted before the date that the ANDA or 505(b)(2) 

309 application (excluding an amendment or supplement) was submitted to 

310 FDA, and

311

312 • The patent owner or NDA holder initiates a patent infringement action on 

313 the patent within 45 days of the date that it receives notice of the 

certification. 26 314 

315

316 No 30-month stay of approval will result from a patent subject to the MMA, even if 

317 litigation is initiated based on a paragraph IV certification to the patent, if either of the 

318 conditions described above is not satisfied. That is, no 30-month stay of approval will 

319 apply if the patent was submitted to FDA on or after the date the ANDA or 505(b)(2) 

320 application with a paragraph IV certification to the patent was submitted. (Note that this 

321 is the case even if the later-submitted patent is the first listed patent to claim the drug 

322 described in the ANDA or 505(b)(2) application.) In addition, a 30-month stay will not 

323 ensue if litigation is initiated more than 45 days after the date that the patent owner or 

324 NDA holder receives notice of the certification.

325

326 3. An ANDA was submitted to FDA in November 2003 with multiple patent 

327 certifications, including a paragraph IV certification to at least one patent. 

328 No patent infringement lawsuit was initiated, but a new patent was 

329 submitted to FDA on December 27, 2003. What are the ANDA applicant’s 

330 certification and notification obligations? Is a 30-month stay of approval 

331 possible based on the December 27 patent? 

332

 

26 See MMA Title XI section 1101(a)(2)(A) and 1101(b)(2)(B) (amending section 505(j)(5)(B)(iii) and 

505(c)(3)(C) of the Act, respectively); see also MMA Title XI section 1101(c)(3).
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333 Under section 505(j)(2)(A)(vii) of the Act (which was not amended by the MMA), the 

334 ANDA applicant would be required to provide a certification with respect to the 

335 December 27, 2003, patent. With regard to notice, as discussed in response to question 1 

336 in subsection II.C of this document, the MMA amends section 505 of the Act to make 

337 clear that ANDA and 505(b)(2) applicants must provide notice of all paragraph IV 

certifications.27 338 Accordingly, if the applicant amends its ANDA to include a paragraph 

339 IV certification to the December 27, 2003, patent, it would be required by the MMA to 

340 notify the patent owner and NDA holder of its certification at the time its amendment is 

submitted.28 341

342

343 As previously discussed, the MMA provides that a 30-month stay cannot arise from a 

344 patent submitted on or after August 18, 2003, unless the patent was also submitted to 

FDA before the ANDA or 505(b)(2) application was submitted.29 345 Accordingly, no 30-

346 month stay of approval would be possible based on the December 27, 2003, patent in this 

347 question.

348

349 4. Is a 30-month stay based on a patent possible if the patent (1) is submitted to 

350 FDA on or after August 18, 2003, and before an ANDA or 505(b)(2) 

351 application with a paragraph IV certification to the patent is submitted, and 

352 (2) is not published in the Orange Book before the application’s submission?

353

354 The patent described in this question could provide the basis for a 30-month stay if the 

355 other conditions for a stay, as discussed above, are satisfied. As previously noted, under 

356 the MMA, a patent that is submitted to FDA on or after August 18, 2003, could 

357 potentially trigger a 30-month stay if it is also “submitted . . . before the date on which 

358 the [ANDA] application (excluding an amendment or supplement to the application) is 

submitted.”30 359 Eligibility for a 30-month stay thus turns on when the patent is submitted

360 to FDA, as opposed to when it is published in the Orange Book. Because the patent in 

361 this question meets the time frames for submission specified in the MMA, it can result in 

362 a 30-month stay, regardless of when it is published in the Orange Book.

363

364 E. 180-Day Exclusivity

365

366 What ANDAs are subject to the MMA’s new 180-day exclusivity provisions? 

367

368 With two exceptions, the new provisions relating to 180-day exclusivity govern only 

369 ANDAs filed after the date of the MMA’s enactment (December 8, 2003) that reference a 

370 listed drug for which no paragraph IV certification was made in any ANDA before that 

date.31 371 The two exceptions concern the forfeiture of 180-day exclusivity by entering into 

 

27 See MMA Title XI section 1101(a)(1)(A) and 1101(b)(1)(A) (amending section 505(j)(2)(B)(i) and 

505(b)(3)(A) of the Act, respectively); see also MMA Title XI section 1101(c)(2).

28 See MMA Title XI section 1101(a)(1) (creating new section 505(j)(2)(B)(ii)(II) of the Act).

29 See MMA Title XI section 1101(a)(2)(A)(ii)(I) (amending section 505(j)(5)(B)(iii) of the Act).

30 MMA Title XI section 1101(a)(2)(A)(ii)(I) (amending section 505(j)(5)(B)(iii) of the Act).

31 See MMA Title XI section 1102(b)(1).
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a collusive agreement and the triggering of the exclusivity period by judicial action.32 372 All 

373 other ANDAs remain subject to the 180-day exclusivity provisions in effect before the 

374 MMA’s enactment. Thus, for example, FDA’s guidance for industry, 180-Day 

375 Exclusivity When Multiple ANDAs Are Submitted on the Same Day, still applies to 

376 ANDAs submitted before, on, or after December 8, 2003, that reference a listed drug for 

377 which a paragraph IV certification had been made in any ANDA before December 8, 

378 2003. FDA will further interpret provisions of the MMA relating to 180-day exclusivity 

379 in future regulations and/or guidances.

380

381 F. Applicability and Effective Dates

382

383 What are the effective dates of the various provisions of the MMA?

384

MMA Section Amended or Added 

Sections of the Act

Effective Date 

or Scope of Applicability

1101(a)(1) and (b)(1)

(Amending or 

supplementing an 

application)

505(j)(2)(D) and 

505(b)(4)

A change in listed drug or 

proposed drug made on or after 

December 8, 2003

1101(a)(1) and (b)(1)

(Notice provisions)

505(j)(2)(B) and 

505(b)(3)

Any paragraph IV certification 

submitted on or after August 18, 

2003 in an application, 

amendment, or supplement

1101(a)(2)(A)(ii)(I) and 

(b)(2)(B)(i)

(30-month stay provisions)

505(j)(5)(B)(iii) and 

505(c)(3)(C)

Retroactive to patent 

information submitted to FDA 

on or after August 18, 2003

1101(a)(2)(A)(ii)(II) and 

(b)(2)(B)(ii)

(Court decision provisions 

for approval)

505(j)(5)(B)(iii) and 

505(c)(3)(C)

Any proceeding pending on or 

after December 8, 2003, 

regardless of the date on which 

the proceeding was or is 

commenced

 

32 The exception relating to forfeiture based on a first ANDA applicant’s entry into an anti-competitive 

agreement applies if conditions specified in the MMA are met, regardless of when the first ANDA 

paragraph IV certification for the listed drug was made (see MMA Title XI section 1102(b)(2)). The 

second exception relates to the MMA’s definition of the term decision of a court for purposes of section 

505(j)(5)(B)(iv) of the Act. As discussed in response to question 2 in subsection II.B of this document, the 

MMA’s definition of this term applies to alter the court decision trigger for 180-day exclusivity for all 

ANDAs other than those filed after December 8, 2003, for a listed drug for which no paragraph IV 

certification was made in any ANDA before that date (see MMA Title XI section 1102(b)(3)).
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MMA Section Amended or Added 

Sections of the Act

Effective Date 

or Scope of Applicability

1101(a)(2)(C) and (b)(2)(D)

(Civil action to obtain 

patent certainty)

505(j)(5)(C) and 

505(c)(3)(D)

Any proceeding pending on or 

after December 8, 2003, 

regardless of the date on which 

the proceeding was or is 

commenced

1102(a)

(180-day exclusivity period)

505(j)(5)(B)(iv) and 

505(j)(5)(D)

ANDAs filed after December 8, 

2003 for a listed drug for which 

no paragraph IV certification

had been made in any ANDA 

before December 8, 2003, 

except as provided in the box 

immediately following

1102(a)(2)

(Collusive agreement 

forfeiture provision)

New 505(j)(5)(D)(i)(V) ANDAs filed after December 8, 

2003, regardless of when the 

first paragraph IV certification 

was made for the listed drug 

referenced in any ANDA

1102(b)(3)

(Meaning of decision of a 

court that will trigger the 

beginning of 180-day 

exclusivity for certain 

ANDAs)

505(j)(5)(B)(iv) ANDAs for a listed drug for 

which a paragraph IV 

certification was made in any 

ANDA before December 8, 

2003, and for which there was 

no court decision or commercial 

marketing that triggered 180-

day exclusivity (under the Act 

pre-MMA) on or before 

December 8, 2003

1103(a)

(Bioavailability/

bioequivalence)

505(j)(8) December 8, 2003