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: N215973

Product 001
LENACAPAVIR SODIUM (SUNLENCA) SOLUTION EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	9951043	02/28/2034	DS	DP	U-3507		01/18/2023
001	10071985	08/17/2037	DS	DP			01/18/2023
001	10654827	08/17/2037			U-3507		01/18/2023
001	11267799	08/16/2038	DS				01/18/2023
001	11944611	06/04/2041			U-3507		04/23/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	12/22/2027

 

 

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