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: N022024

Product 002
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE (ACTOPLUS MET XR) TABLET, EXTENDED RELEASE 1GM;EQ 30MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6790459 03/17/2021
U-974 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
002 6866866 03/17/2021 DP
002 7785627 07/31/2026 DP
002 7959946 07/31/2026 DP
002 8470368 09/19/2023 DP
002 8668931 09/19/2023 DP
002 9060941 09/19/2023 DP
07/21/2015

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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