Is there a generic for Varenicline tartrate?

Yes. The FDA Orange Book lists 22 approved generic (ANDA) applications for Varenicline tartrate, referencing the brand TYRVAYA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Varenicline tartrate?

TYRVAYA (NDA 213978, OYSTER POINT PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Varenicline tartrate?

The Orange Book lists 12 patents against Varenicline tartrate products, with the earliest listed expiry in 2035. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Varenicline tartrate are approved?

Varenicline tartrate is approved in the following dosage forms: spray, tablet.

FDA Orange Book · active-ingredient family

Varenicline tartrate

Varenicline tartrate: 2 brands, 22 generics; first approved May 10, 2006; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 22 ANDA applications approved.

Earliest patent expiry Oct 19, 2035

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 19, 2035

in 9 yr 4 mo

Brand (NDA) products

Originator applications

TYRVAYARLDRS
OYSTER POINT PHARMANDA 2139782021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.03MG BASE/SPRAY SPRAY NASAL Rx —
CHANTIXRLD
PF PRISM CVNDA 02192820062 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.03MG BASE/SPRAY	SPRAY	NASAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Generic (ANDA) products (22)

Abbreviated applications

VARENICLINE TARTRATE
SOMERSET THERAPS LLCANDA 21938220262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
UMEDICAANDA 21898520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
MICRO LABSANDA 21830220252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
RHODES PHARMSANDA 21326820252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Discontinued —
EQ 1MG BASE TABLET ORAL Discontinued —
VARENICLINE TARTRATE
VIWIT PHARMANDA 21287920252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
AUROBINDO PHARMAANDA 21459520252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
SHILPAANDA 21661520252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
MACLEODS PHARMS LTDANDA 21504820242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
REGCON HOLDINGSANDA 21910620242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
DR REDDYSANDA 21593120242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
PIRAMALANDA 21711520242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
AJANTA PHARMA LTDANDA 21301920242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
NE RX PHARMAANDA 21728320242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
PHARMOBEDIENTANDA 20201920242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Discontinued —
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
LUPINANDA 21186220232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
HETERO LABS LTD IIIANDA 21457120232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
ALKEM LABS LTDANDA 21455720232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
MANKIND PHARMAANDA 21425520232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
KANCHAN HLTHCAREANDA 21715120232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
ZYDUSANDA 21672320232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
APOTEXANDA 20196220232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB
VARENICLINE TARTRATE
PH HEALTHANDA 20178520212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.5MG BASE TABLET ORAL Rx AB
EQ 1MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 1MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.5MG BASE	TABLET	ORAL	Rx	AB
EQ 1MG BASE	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11224598	Oct 19, 2035	in 9 yr 4 mo	U-1900
10456396	Oct 19, 2035	in 9 yr 4 mo	ProductU-1900
9597284	Oct 19, 2035	in 9 yr 4 mo	U-1900
9532944	Oct 19, 2035	in 9 yr 4 mo	U-1900
9504644	Oct 19, 2035	in 9 yr 4 mo	U-1900
11911380	Oct 19, 2035	in 9 yr 4 mo	U-1900
11903943	Oct 19, 2035	in 9 yr 4 mo	U-1900
11903941	Oct 19, 2035	in 9 yr 4 mo	U-1900
12576080	Oct 19, 2035	in 9 yr 4 mo	U-1900
12653824	Oct 19, 2035	in 9 yr 4 mo	Product
9504645	Oct 19, 2035	in 9 yr 4 mo	Product
11903942	Oct 19, 2035	in 9 yr 4 mo	Product

Approval history

FDA approval span

First approval

May 10, 2006

20 yr 6 mo ago

Most recent approval

Jul 06, 2026

29 d ago

Approvals span 2006–2026 across 24 FDA applications.

Brand (NDA) 28%

Generic (ANDA) 2292%

Varenicline tartrate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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