FDA's role in making exclusivity determinations

Food and Drug Law Journal

Volumn 54, Issue 2, 1999, Pages 195-203

  Dickinson, Elizabeth H ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; NON PRESCRIPTION DRUG; ORPHAN DRUG;

CLINICAL STUDY; COMPETITION; CONFERENCE PAPER; DRUG APPROVAL; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; PATENT; PATIENT INFORMATION; PUBLIC HEALTH;

EID: 0032775905     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (28)

1. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified in scattered sections of 15 U.S.C. (1994), 21 U.S.C. (1994), 28 U.S.C. (1994), and 35 U.S.C. (1994)).
2. Pub. L. No. 75-717, § 505, 52 Stat 1040, 1052 (1938) (codified as amended 21 U.S.C. § 355).
3. 21 C.F.R. pt. 314 (1998).
4. 21 U.S.C. § 355(b)(1) (FDCA § 505(b)(1)).
5. An NDA containing data that was not generated by the sponsor, but for which the sponsor has obtained a right of reference, also would be considered a full NDA. See 21 C.F.R. § 314.3(b).
6. See 21 U.S.C. § 355(c)(2) (FDCA § 505(c)(2)). A section 505(b)(2) application is a new drug application submitted under FDCA § 505(b)(1) where one or more of the investigations relied on by the applicant for approval were not conducted by or for the applicant, and for which the applicant has not obtained a right of reference. 21 U.S.C. § 355(b)(2) (FDCA § 505(b)(2)).
7. FOOD & DRUG ADMIN., CTR. FOR DRUG EVALUATION & RESEARCH, APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS (CCH 18th ed. 1998).
8. See 21 U.S.C. § 355(j)(2)(A)(viii) (FDCA § 505(j)(2)(A)(viii)).
9. 35 U.S.C. § 271(e).
10. Torpharm v. Shalala, No. 97-1925, U.S, Dist. LEXIS 21983 (D.D.C. Sept. 15, 1997); appeal withdrawn and remanded, 1998 U.S. App. LEXIS 4681 (D.C. Cir. Feb. 5, 1998); vacated No. 97-1925 (D.D.C. Apr. 9, 1998).
11. Mova Pharm. Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998).
12. Id. at 1064.
13. Granutec, Inc. v. Shalala, Nos. 97-1873, 97-1874, 1998 U.S. App. LEXIS 6685 (4th Cir. Apr. 3, 1998).
14. No, 96-2861 (D.D.C. June 1, 1998).
15. 63 Fed. Reg. 59,710 (Nov. 5, 1998).
16. See Purepac v. Friedman, 162 F.3d 1201 (D.C. Cir. 1998).
17. 21 U.S.C. § 355(j)(5)(B)(iv)(I),(II) (FDCA §§ 505(j)(5)(B)(iv)(I),(II)).
18. Food & Drug Admin., Guidance for Industry - 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, & Cosmetic Act (June 1998).
19. 35 U.S.C. § 156.
20. Immunex Corp. v. FDA, No. 97-1689 (D.D.C. Oct. 31, 1997) (dismissed).
21. 62 Fed. Reg. 2167 (Jan. 15, 1997).
22. Upjohn Co. v. Kessler, 938 F. Supp. 439 (W.D. Mich. 1996).
23. Bristol-Myers Squibb v. Shalala, 91 F.3d 1493 (D.C. Cir. 1996).
24. Pub. L. No. 97-414, 96 Stat 2049 (1983) (codified at 21 U.S.C. §§ 360aa et seq.).
25. Ch. 288, 37 Stat. 309 (1912) (codified at 42 U.S.C. §§ 201-99 (1994)).
26. Baker-Norton Pharmaceuticals, Inc. v. FDA, No. 98-927 (D.D.C. filed Apr. 14, 1998).
27. Pub. L. No. 105-115, 111 Stat. 2296 (1997) (codified at 28 U.S.C. § 352(a)).
28. National Pharm. Alliance v. Henney, No. 99-0394, 1999 WL 258286 (D.D.C. filed Apr. 20, 1999).