These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
3. Drug marketing exclusivity under United States and European Union law. Junod V. Food Drug Law J; 2004; 59(4):479-518. PubMed ID: 15875347 [No Abstract] [Full Text] [Related]
5. Applications for FDA approval to market a dew 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. Food and Drug Administration, HHS. Fed Regist; 2003 Jun 18; 68(117):36675-712. PubMed ID: 12814136 [Abstract] [Full Text] [Related]
8. A brief history of 180-day exclusivity under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. Lietzan EK. Food Drug Law J; 2004 Jun 18; 59(2):287-323. PubMed ID: 15298013 [Abstract] [Full Text] [Related]
9. New drugs for human use; clarification of requirements for patent holder notification--FDA. Proposed rule. Fed Regist; 1998 Mar 06; 63(44):11174-7. PubMed ID: 10177511 [Abstract] [Full Text] [Related]
12. An Administrative Meter Maid: Using Inter Partes Review and Post-Grant Review to Curb Exclusivity Parking via the "Failure to Market" Provision of the Hatch-Waxman Act. Apel BT. Mich Law Rev; 2015 Mar 06; 114(1):107-36. PubMed ID: 26394458 [Abstract] [Full Text] [Related]
15. The Food and Drug Administration and patent law at a crossroads: the listing of polymorph patents as a barrier to generic drug entry. Srivastava D. Food Drug Law J; 2004 Mar 06; 59(2):339-54. PubMed ID: 15298015 [No Abstract] [Full Text] [Related]
16. Balancing US patent and FDA approval processes: strategically optimizing market exclusivity. Fernandez DS, Huie JT. Drug Discov Today; 2004 Jun 15; 9(12):509-12. PubMed ID: 15183155 [No Abstract] [Full Text] [Related]
17. Repercussions of the Drug Price Competition and Patent Term Restoration Act of 1984. Hogan GF. Am J Hosp Pharm; 1985 Apr 15; 42(4):849-51. PubMed ID: 4014238 [Abstract] [Full Text] [Related]