Is there a generic for Ketotifen fumarate?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Ketotifen fumarate, referencing the brand ACUVUE THERAVISION WITH KETOTIFEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ketotifen fumarate?

ACUVUE THERAVISION WITH KETOTIFEN (NDA 022388, JOHNSON JOHNSON VISN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ketotifen fumarate?

The Orange Book lists 2 patents against Ketotifen fumarate products, with the earliest listed expiry in 2028. 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 Ketotifen fumarate are approved?

Ketotifen fumarate is approved in the following dosage forms: drug-eluting contact lens, solution/drops.

FDA Orange Book · active-ingredient family

Ketotifen fumarate

Ketotifen fumarate: 3 brands, 5 generics; first approved May 09, 2006; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 5 ANDA applications approved.

Earliest patent expiry Mar 27, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 27, 2028

in 1 yr 9 mo

Originator applications

Brand (NDA) products

ACUVUE THERAVISION WITH KETOTIFENRLD

JOHNSON JOHNSON VISNNDA 0223882022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 19MCG BASE	DRUG-ELUTING CONTACT LENS	OPHTHALMIC	Discontinued	—

ALAWAYRLDRS

BAUSCH AND LOMBNDA 02199620062 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.025% BASE	SOLUTION/DROPS	OPHTHALMIC	OTC	—
EQ 0.025% BASE	SOLUTION/DROPS	OPHTHALMIC	OTC	—

ZADITORRLD

ALCON PHARMANDA 0210662006

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.025% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Abbreviated applications

Generic (ANDA) products (5)

ALAWAY

BAUSCH AND LOMB INCANDA 2081582020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.025% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

KETOTIFEN FUMARATE

UNICHEMANDA 2040592020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.025% BASE	SOLUTION/DROPS	OPHTHALMIC	OTC	—

ZADITORRS

ALCON PHARMS LTDANDA 0772002008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.025% BASE	SOLUTION/DROPS	OPHTHALMIC	OTC	—

KETOTIFEN FUMARATE

SENTISSANDA 0779582007

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.025% BASE	SOLUTION/DROPS	OPHTHALMIC	OTC	—

KETOTIFEN FUMARATE

APOTEX INCANDA 0773542006

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.025% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9474746	Mar 27, 2028	in 1 yr 9 mo	Product
9962376	Jun 27, 2030	in 4 yr	Product

FDA approval span

Approval history

First approval

May 09, 2006

20 yr 6 mo ago

Most recent approval

Feb 25, 2022

4 yr 5 mo ago

Approvals span 2006–2022 across 8 FDA applications.

Brand (NDA) 338%

Generic (ANDA) 563%

Ketotifen fumarate — 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.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo