85638 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 

related ANDAs for ciprofloxacin HCl, 

oral tablet (e.g., the 250 mg base, 500 mg 

base, or 750 mg base strength products) 

remain approved. Distribution of CIPRO 

(ciprofloxacin HCl) oral tablet, EQ 100 

mg base and ciprofloxacin HCl, oral 

tablet, EQ 100 mg base in interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the FD&C Act (21 U.S.C. 

355(a) and 331(d)). 

Application No. Drug Applicant 

NDA 019537 ....... CIPRO (ciprofloxacin HCl) oral tablet, 

EQ 100 mg base.

Bayer Healthcare Pharmaceuticals Inc., 100 Bayer Blvd., P.O. Box 915, 

Whippany, NJ 07981–0915. 

ANDA 075593 ..... Ciprofloxacin HCl, oral tablet, EQ 100 

mg base.

Dr. Reddy’s Laboratories Ltd., 107 College Rd. East, 2nd Floor Princeton, NJ 

08540. 

ANDA 075817 ..... Ciprofloxacin HCl, oral tablet, EQ 100 

mg base.

Rising Pharma Holdings, Inc., 2 Tower Center Blvd., Suite 1401A, East Brunswick, NJ 08816. 

ANDA 075939 ..... Ciprofloxacin HCl, oral tablet, EQ 100 

mg base.

Amneal Pharmaceuticals, LLC, 50 Horseblock Rd., Brookhaven, NY 11719. 

ANDA 076794 ..... Ciprofloxacin HCl, oral tablet, EQ 100 

mg base.

Watson Laboratories, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 

07054. 

ANDA 076912 ..... Ciprofloxacin HCl, oral tablet, EQ 100 

mg base.

Taro Pharmaceutical Industries, Ltd., 1600 Stewart Ave., Suite 604, Westbury, 

NY 11590. 

Dated: December 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27015 Filed 12–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–E–0791] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; VILTEPSO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for VILTEPSO and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect must submit either electronic 

or written comments and ask for a 

redetermination by February 6, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

June 5, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 6, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal:

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–E–0791 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; VILTEPSO.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through

Friday, 240–402–7500.

• Confidential Submissions—To

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 85639 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with § 10.20 (21 

CFR 10.20) and other applicable 

disclosure law. For more information 

about FDA’s posting of comments to 

public dockets, see 80 FR 56469, 

September 18, 2015, or access the 

information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background

The Drug Price Competition and

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, VILTEPSO 

(viltolarsen), which is indicated for the 

treatment of Duchenne muscular 

dystrophy (DMD) in patients who have 

a confirmed mutation of the DMD gene 

that is amenable to exon 53 skipping. 

This indication is approved under 

accelerated approval based on an 

increase in dystrophin production in 

skeletal muscle observed in patients 

treated with VILTEPSO. Continued 

approval for this indication may be 

contingent upon verification and 

description of clinical benefit in a 

confirmatory trial. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

VILTEPSO (U.S. Patent No. 9,079,934) 

from Nippon Shinyaku Co., LTD. and 

the USPTO requested FDA’s assistance 

in determining the patent’s eligibility 

for patent term restoration. In a letter 

dated August 24, 2022, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

VILTEPSO represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review

Period

FDA has determined that the 

applicable regulatory review period for 

VILTEPSO is 1,573 days. Of this time, 

1,255 days occurred during the testing 

phase of the regulatory review period, 

while 318 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355(i)) became effective: April 24, 2016. 

The applicant claims March 24, 2016, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was April 24, 2016, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: September 30, 2019. 

The applicant claims February 1, 2019, 

as the date the new drug application 

(NDA) for VILTEPSO (NDA 212154) was 

initially submitted. However, FDA 

records indicate that on September 30, 

2019, NDA 212154 (a complete 

application) was submitted. 

3. The date the application was

approved: August 12, 2020. FDA has 

verified the applicant’s claim that NDA 

212154 was approved on August 12, 

2020. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,077 days of patent 

term extension. 

III. Petitions

Anyone with knowledge that any of

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to:

must be timely (see DATES), must be

filed in accordance with § 10.20, must

contain sufficient facts to merit an FDA

investigation, and must certify that a

true and complete copy of the petition

has been served upon the patent

applicant. (See H. Rept. 857, part 1, 98th

Cong., 2d sess., pp. 41–42, 1984.)

Petitions should be in the format

specified in 21 CFR 10.30.

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: December 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27013 Filed 12–7–23; 8:45 am] 

BILLING CODE 4164–01–P 


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