FDA Orange Book

Generic for Vemlidy

Vemlidy contains tenofovir alafenamide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Vemlidy is tenofovir alafenamide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Vemlidy products in the Orange Book

Vemlidy products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 25MG BASE	Marketed (Rx)	AB	1	AB

NDA 208464, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tenofovir alafenamide

Approved generic versions of Vemlidy
Company	ANDA	TE code	Approved	Strengths
LUPIN LTD	214226	AB (A-rated, therapeutically equivalent)	March 30, 2023	EQ 25MG BASE

Vemlidy patents

Patents listed for Vemlidy
Patent	Expires	Covers	Use code	NDA
8754065	August 15, 2032	Drug substance, Drug product	U-999	208464
8754065	August 15, 2032	Drug substance, Drug product	U-1275	208464
9296769	August 15, 2032	Drug substance, Drug product	U-1275	208464
8754065	August 15, 2032	Drug substance, Drug product	U-3880	208464
9296769	August 15, 2032	Drug substance, Drug product	U-3880	208464
9296769	August 15, 2032	Drug substance, Drug product	U-999	208464
9296769*PED	February 15, 2033	Method of use	None	208464
8754065*PED	February 15, 2033	Method of use	None	208464

Vemlidy exclusivity

Exclusivity listed for Vemlidy
Code	Meaning	Expires	NDA
NPP	New patient population	March 27, 2027	208464

Vemlidy NDC codes

61958-2301

Questions

Is there a generic for Vemlidy?

Yes. The generic name for Vemlidy is tenofovir alafenamide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Vemlidy?

The active ingredient in Vemlidy is tenofovir alafenamide, per the FDA Orange Book.

When does the Vemlidy patent expire?

The last patent listed for Vemlidy in the Orange Book expires February 15, 2033. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.