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: N215413

Product 001
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE (TRIUMEQ PD) TABLET, FOR SUSPENSION EQ 60MG BASE;EQ 5MG BASE;30MG

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			04/07/2022
001	8129385*PED	04/05/2028
001	9242986	12/08/2029	DS	DP			04/07/2022
001	9242986*PED	06/08/2030

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NPP	06/15/2026
001	NPP *PED	12/15/2026

 

 

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