Generic for Descovy: Emtricitabine and Tenofovir Alafenamide

Yes. The generic name for Descovy is emtricitabine and tenofovir alafenamide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Descovy products the Orange Book lists.

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Descovy products in the Orange Book

Descovy products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	120MG;EQ 15MG BASE	Marketed (Rx)	None	0	None
tablet, oral	200MG;EQ 25MG BASE	Marketed (Rx)	AB	2	AB

NDA 208215, 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 emtricitabine and tenofovir alafenamide

Approved generic versions of Descovy
Company	ANDA	TE code	Approved	Strengths
MACLEODS PHARMACEUTICALS LTD	214216	AB (A-rated, therapeutically equivalent)	April 7, 2026	200MG;EQ 25MG BASE
NATCO PHARMA LTD	214173	AB (A-rated, therapeutically equivalent)	August 26, 2026	200MG;EQ 25MG BASE

Descovy patents

Patents listed for Descovy
Patent	Expires	Covers	Use code	NDA
8754065	August 15, 2032	Drug substance, Drug product	U-1663	208215
9296769	August 15, 2032	Drug substance, Drug product	U-1663	208215
9296769	August 15, 2032	Drug substance, Drug product	U-257	208215
8754065	August 15, 2032	Drug substance, Drug product	U-1259	208215
9296769	August 15, 2032	Drug substance, Drug product	U-1259	208215
8754065	August 15, 2032	Drug substance, Drug product	U-257	208215
8754065*PED	February 15, 2033	Method of use	None	208215
9296769*PED	February 15, 2033	Method of use	None	208215
12661323	June 29, 2036	Drug product	None	208215
12648911	June 29, 2036	Method of use	U-1663	208215
12648911	June 29, 2036	Method of use	U-1259	208215
12629338	June 29, 2036	Drug product	None	208215
12678408	June 29, 2036	Drug product	None	208215

Descovy exclusivity

Exclusivity listed for Descovy
Code	Meaning	Expires	NDA
M-316	Miscellaneous	June 20, 2028	208215
ODE-554	Orphan drug exclusivity	January 7, 2029	208215
ODE-556	Orphan drug exclusivity	June 20, 2032	208215

Descovy NDC codes

Questions

Is there a generic for Descovy?

Yes. The generic name for Descovy is emtricitabine and tenofovir alafenamide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Descovy products the Orange Book lists.

What is the generic name for Descovy?

The active ingredient in Descovy is emtricitabine and tenofovir alafenamide, per the FDA Orange Book.

When does the Descovy patent expire?

The last patent listed for Descovy in the Orange Book expires June 29, 2036. 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.

Generic for Descovy