FDA Orange Book

Generic for Viagra

Viagra contains sildenafil. 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 Viagra is sildenafil. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Viagra products in the Orange Book

Viagra products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 100MG BASE	Marketed (Rx)	AB	16	AB
tablet, oral	EQ 25MG BASE	Marketed (Rx)	AB	16	AB
tablet, oral	EQ 50MG BASE	Marketed (Rx)	AB	16	AB

NDA 020895, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic sildenafil

Approved generic versions of Viagra
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	077342	AB (A-rated, therapeutically equivalent)	March 9, 2016	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
AUROBINDO PHARMA LTD	203962	AB (A-rated, therapeutically equivalent)	June 11, 2018	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
HETERO LABS LTD UNIT V	202659	AB (A-rated, therapeutically equivalent)	June 11, 2018	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
RUBICON RESEARCH LTD	204882	AB (A-rated, therapeutically equivalent)	June 11, 2018	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
TORRENT PHARMACEUTICALS LTD	091448	AB (A-rated, therapeutically equivalent)	June 11, 2018	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
AMNEAL PHARMACEUTICALS OF NY LLC	202023	AB (A-rated, therapeutically equivalent)	June 27, 2018	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
AJANTA PHARMA LTD	206401	AB (A-rated, therapeutically equivalent)	October 12, 2018	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
CHARTWELL RX SCIENCES LLC	212051	AB (A-rated, therapeutically equivalent)	March 22, 2019	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
APPCO PHARMA LLC	207178	AB (A-rated, therapeutically equivalent)	March 2, 2020	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
SUNSHINE LAKE PHARMA CO LTD	213032	AB (A-rated, therapeutically equivalent)	June 11, 2020	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
REYOUNG CORPORATION	208494	AB (A-rated, therapeutically equivalent)	June 12, 2020	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
UMEDICA LABORATORIES PRIVATE LTD	209302	AB (A-rated, therapeutically equivalent)	August 25, 2020	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
MACLEODS PHARMACEUTICALS LTD	202255	AB (A-rated, therapeutically equivalent)	April 19, 2023	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
NOVITIUM PHARMA LLC	216383	AB (A-rated, therapeutically equivalent)	August 29, 2023	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
CADILA PHARMACEUTICALS LTD	218045	AB (A-rated, therapeutically equivalent)	November 28, 2023	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE
JUBILANT GENERICS LTD	201156	AB (A-rated, therapeutically equivalent)	December 20, 2024	EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE

Viagra NDC codes

Questions

Is there a generic for Viagra?

Yes. The generic name for Viagra is sildenafil. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Viagra?

The active ingredient in Viagra is sildenafil, per the FDA Orange Book.

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.