Opinion ID: 787085
Heading Depth: 2
Heading Rank: 2

Heading: anda

Text: 12 On April 5, 2000, Apotex filed an ANDA seeking approval by the FDA to market a generic version of Ceftin(R). Apotex creates its generic drug by: (1) dissolving excipients zinc chloride and sorbitol into a solution of water and acetone along with approximately 98% pure crystalline CA; (2) mixing the resulting solution; (3) spray drying the solution under nitrogen; (4) collecting, compacting, and milling the resulting spray dried amorphous particles into granules; (5) mixing the granules with additional excipients; (6) compressing the resulting blend into a tablet core; and (7) coating the tablet. Apotex's spray dried solution creates an amorphous co-precipitate comprised of 90% CA, 9% sorbitol, and 1% zinc chloride by mass. On November 26, 2002, the patent office issued to Apotex U.S. Patent No. 6,485,744 (the  '744 patent) relating to Apotex's unique use of zinc chloride as a stabilizing excipient for CA. 13 Apotex's ANDA filing is atypical in that it did not contain a certification pursuant to 21 U.S.C. § 355(j)(2)(A). Under the Hatch-Waxman Act, most patentees and NDA holders must list patents related to their approved drugs in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations publication (the Orange Book). 21 U.S.C. § 355(b)(1). Reciprocally, a generic company has an obligation to consult the Orange Book before filing an ANDA and certify that either (I) no patent information is listed in the Orange Book for the proposed generic drug; (II) that the listed patents have expired; (III) that the listed patents will expire before the generic company markets its product; or (IV) that the patents listed are invalid or will not be infringed by the generic drug (a paragraph IV certification). 21 U.S.C. § 355(j)(2)(A)(I)-(IV). 14 In the current case, however, CA was approved under 21 U.S.C. § 357, a now-repealed provision of the Federal Food, Drug, and Cosmetic Act relating to antibiotics. Drug manufacturers who utilized Section 357 to obtain FDA approval are exempt from listing the patents related to their antibiotic in the Orange Book. Correspondingly, ANDA applicants attempting to market generics of such antibiotics are not required to file a certification under 21 U.S.C. § 355(j)(2)(A). See Pub. L. 105-115, Title I, § 125(d), 11 Stat. 2326 (1997). Accordingly, Glaxo did not list the '181 or '833 patent in the Orange Book, and Apotex therefore did not file a paragraph IV certification in its ANDA application.