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: N210238

Product 001
AVATROMBOPAG MALEATE (DOPTELET) TABLET EQ 20MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7638536 05/05/2025 DS DP
06/15/2018
001 8338429 06/30/2023
U-2577 TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAS HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
07/25/2019
001 8765764 01/15/2023
U-2314 TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC LIVER DISEASE WHO IS SCHEDULED TO UNDERGO A PROCEDURE USING DOPTELET
U-2578 TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC LIVER DISEASE WHO IS SCHEDULED TO UNDERGO A PROCEDURE
06/15/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-802TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
COMPETITIVE GENERIC THERAPY
06/26/2022
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
05/21/2023
001
ODE-246TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
COMPETITIVE GENERIC THERAPY
06/26/2026

 

 


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