FDA Orange Book

Generic for Revatio

Revatio 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 Revatio is sildenafil. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.

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Revatio products in the Orange Book

Revatio products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
for suspension, oral	EQ 10MG BASE/ML	Discontinued	None	11	AB
solution, intravenous	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	Marketed (Rx)	AP	1	AP
tablet, oral	EQ 20MG BASE	Marketed (Rx)	AB	10	AB

NDA 203109, 022473, 021845, 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 Revatio
Company	ANDA	TE code	Approved	Strengths
CHARTWELL RX SCIENCES LLC	202598	AB (A-rated, therapeutically equivalent)	November 6, 2012	EQ 20MG BASE
TORRENT PHARMACEUTICALS LTD	091479	AB (A-rated, therapeutically equivalent)	November 6, 2012	EQ 20MG BASE
WATSON LABORATORIES INC	202503	AB (A-rated, therapeutically equivalent)	November 6, 2012	EQ 20MG BASE
AMNEAL PHARMACEUTICALS	202025	AB (A-rated, therapeutically equivalent)	February 28, 2013	EQ 20MG BASE
MACLEODS PHARMACEUTICALS LTD	203814	AB (A-rated, therapeutically equivalent)	December 17, 2013	EQ 20MG BASE
HETERO LABS LTD UNIT V	203623	AB (A-rated, therapeutically equivalent)	November 26, 2014	EQ 20MG BASE
EUGIA PHARMA SPECIALITIES LTD	203988	AP (A-rated, therapeutically equivalent)	April 1, 2015	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
AUROBINDO PHARMA LTD	203963	AB (A-rated, therapeutically equivalent)	November 18, 2015	EQ 20MG BASE
RUBICON RESEARCH LTD	204883	AB (A-rated, therapeutically equivalent)	June 20, 2016	EQ 20MG BASE
AJANTA PHARMA LTD	210394	AB (A-rated, therapeutically equivalent)	May 4, 2018	EQ 20MG BASE
NOVITIUM PHARMA LLC	212260	AB (A-rated, therapeutically equivalent)	May 31, 2019	EQ 10MG BASE/ML
AJANTA PHARMA LTD	212883	AB (A-rated, therapeutically equivalent)	November 27, 2019	EQ 10MG BASE/ML
ALKEM LABORATORIES LTD	212440	AB (A-rated, therapeutically equivalent)	November 27, 2019	EQ 10MG BASE/ML
AMNEAL PHARMACEUTICALS OF NEW YORK LLC	211092	AB (A-rated, therapeutically equivalent)	November 27, 2019	EQ 10MG BASE/ML
TEVA PHARMACEUTICALS USA	211534	AB (A-rated, therapeutically equivalent)	May 29, 2020	EQ 10MG BASE/ML
INVAGEN PHARMACEUTICALS INC	213041	AB (A-rated, therapeutically equivalent)	August 6, 2020	EQ 10MG BASE/ML
CHARTWELL RX SCIENCES LLC	213814	AB (A-rated, therapeutically equivalent)	April 29, 2021	EQ 10MG BASE/ML
HETERO LABS LTD UNIT V	213014	AB (A-rated, therapeutically equivalent)	May 11, 2021	EQ 10MG BASE/ML
MSN LABORATORIES PRIVATE LTD	214641	AB (A-rated, therapeutically equivalent)	February 8, 2022	EQ 10MG BASE/ML
ZYDUS LIFESCIENCES GLOBAL FZE	215708	AB (A-rated, therapeutically equivalent)	September 29, 2022	EQ 10MG BASE/ML
AUROBINDO PHARMA LTD	214773	AB (A-rated, therapeutically equivalent)	December 23, 2022	EQ 10MG BASE/ML
JUBILANT GENERICS LTD	202954	AB (A-rated, therapeutically equivalent)	March 6, 2025	EQ 20MG BASE

Revatio exclusivity

Exclusivity listed for Revatio
Code	Meaning	Expires	NDA
M-287	Miscellaneous	January 31, 2026	203109
ODE-469	Orphan drug exclusivity	January 31, 2030	021845

Revatio NDC codes

Questions

Is there a generic for Revatio?

Yes. The generic name for Revatio is sildenafil. 18 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.

What is the generic name for Revatio?

The active ingredient in Revatio 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.