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: N208564

Product 002
ESTRADIOL (IMVEXXY) INSERT 0.01MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 9180091 12/20/2033 DP
U-2316 TREATMENT OF DYSPAREUNIA
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
06/19/2018
002 9289382 11/21/2032 DP
06/19/2018
002 10258630 12/20/2033
U-2316 TREATMENT OF DYSPAREUNIA
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
04/18/2019
002 10398708 12/20/2033
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
U-2614 TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
09/12/2019
002 10471072 06/18/2033
U-2316 TREATMENT OF DYSPAREUNIA
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
12/06/2019
002 10537581 11/21/2032 DP
U-2316 TREATMENT OF DYSPAREUNIA
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
02/13/2020
002 10568891 06/18/2033
U-2316 TREATMENT OF DYSPAREUNIA
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
03/19/2020
002 10668082 06/18/2033
U-2316 TREATMENT OF DYSPAREUNIA
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
06/10/2020
002 10806697 11/21/2032 DP
10/22/2020
002 10835487 11/21/2032
U-2316 TREATMENT OF DYSPAREUNIA
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
11/18/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
05/29/2021

 

 


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