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: N204017

Product 001
ETHINYL ESTRADIOL; LEVONORGESTREL (TWIRLA) SYSTEM 0.03MG/24HR;0.12MG/24HR

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7045145 03/14/2021 DP
U-2751 A TRANSDERMAL METHOD OF CONTRACEPTION
03/10/2020
001 7384650 03/14/2021 DP
03/10/2020
001 8221784 03/14/2021 DP
03/10/2020
001 8221785 03/14/2021 DP
03/10/2020
001 8246978 08/26/2028 DP
03/10/2020
001 8747888 07/10/2028 DP
03/10/2020
001 9050348 07/10/2028 DP
03/10/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
02/14/2023

 

 


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