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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: N211994

Product 001
DOLUTEGRAVIR SODIUM; LAMIVUDINE (DOVATO) TABLET EQ 50MG BASE;300MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8129385 10/05/2027 DS DP 04/24/2019
001 8129385*PED 04/05/2028
001 9242986 12/08/2029 DS DP 04/24/2019
001 9242986*PED 06/08/2030
001 11234985 01/24/2031 DP U-257 02/24/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NPP 04/05/2027

 

 


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