PMID- 19999288
OWN - HSR
STAT- MEDLINE
DCOM- 20091222
LR  - 20100112
IS  - 1064-590X (Print)
IS  - 1064-590X (Linking)
VI  - 64
IP  - 2
DP  - 2009
TI  - A new history and discussion of 180-day exclusivity.
PG  - 335-90
AB  - Congress created 180-day exclusivity for generic drug applicants in the 1984 
      Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and 
      amended the provision substantially in the Medicare Prescription Drug, 
      Improvement, and Modernization Act of 2003 (MMA). The fundamental goal behind 
      180-day exclusivity was to provide an incentive for generic drug applicants to 
      challenge innovator patents, and the core of the concept--as it has been applied 
      by the Food and Drug Administration (FDA) and the courts--is that the first 
      generic drug applicant to challenge an innovator's patent is entitled to six 
      months of exclusivity against subsequent patent challengers for the same 
      innovator drug. 180-day exclusivity is governed by sections 505(j)(5)(B)(iv) and 
      505(j)(5)(D) of the FDCA. In this article, the authors provide a comprehensive 
      resource on 180-day exclusivity for old abbreviated new drug applications (ANDAs) 
      (but less detail in some places where the 2007 article may be referenced) but 
      focus more discussion on the new provisions as well as some policy and legal 
      issues related to 180-day exclusivity that have not previously addressed.
FAU - Korn, David E
AU  - Korn DE
AD  - Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC, 
      USA.
FAU - Lietzan, Erika
AU  - Lietzan E
FAU - Scott, Shaw W
AU  - Scott SW
LA  - eng
PT  - Historical Article
PT  - Journal Article
PL  - United States
TA  - Food Drug Law J
JT  - Food and drug law journal
JID - 9215384
RN  - 0 (Drugs, Generic)
MH  - Drug Approval/history/*legislation & jurisprudence
MH  - *Drugs, Generic
MH  - History, 20th Century
MH  - Humans
MH  - Investigational New Drug Application/*legislation & jurisprudence
MH  - Legislation, Drug
MH  - Patents as Topic/*legislation & jurisprudence
MH  - Time Factors
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2009/12/17 06:00
MHDA- 2009/12/23 06:00
CRDT- 2009/12/17 06:00
PHST- 2009/12/17 06:00 [entrez]
PHST- 2009/12/17 06:00 [pubmed]
PHST- 2009/12/23 06:00 [medline]
PST - ppublish
SO  - Food Drug Law J. 2009;64(2):335-90.