Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N206162

Product 001
OLAPARIB (LYNPARZA) CAPSULE 50MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7151102 04/29/2022 DS DP
01/15/2015
001 7449464 10/11/2024 DS DP
01/15/2015
001 7981889 10/11/2024 DS DP
01/15/2015
001 8143241 08/12/2027
U-1634 TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
01/15/2015
001 8247416 09/24/2028 DS
01/15/2015
001 8859562 08/04/2031
U-1634 TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
01/15/2015
001 8912187 03/12/2024
U-1634 TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
01/15/2015

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
ODE-83USE OF AS MONOTHERAPY FOR PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA MUTATED (AS DETECTED BY AN FDA-APPROVED TEST) ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
COMPETITIVE GENERIC THERAPY
12/19/2021

 

 


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