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Last Updated: April 28, 2024

KETOTIFEN FUMARATE - Generic Drug Details

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What are the generic sources for ketotifen fumarate and what is the scope of freedom to operate?

Ketotifen fumarate is the generic ingredient in five branded drugs marketed by Johnson Johnson Visn, Bausch And Lomb, Bausch And Lomb Inc, Apotex Inc, Bayshore Pharms Llc, Sentiss, Alcon Pharma, and Alcon Pharms Ltd, and is included in eight NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ketotifen fumarate has forty-four patent family members in fifteen countries.

Seventeen suppliers are listed for this compound.

Summary for KETOTIFEN FUMARATE

International Patents:	44
US Patents:	2
Tradenames:	5
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	12
Patent Applications:	1,545
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for KETOTIFEN FUMARATE
What excipients (inactive ingredients) are in KETOTIFEN FUMARATE?	KETOTIFEN FUMARATE excipients list
DailyMed Link:	KETOTIFEN FUMARATE at DailyMed

See drug prices for KETOTIFEN FUMARATE

Recent Clinical Trials for KETOTIFEN FUMARATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Peking University Third Hospital	Phase 4
Bausch & Lomb Incorporated	Phase 3
ORA, Inc.	Phase 3

See all KETOTIFEN FUMARATE clinical trials

Pharmacology for KETOTIFEN FUMARATE

Drug Class	Histamine-1 Receptor Inhibitor
Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for KETOTIFEN FUMARATE

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Paragraph IV (Patent) Challenges for KETOTIFEN FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZADITOR	Ophthalmic Solution	ketotifen fumarate	0.025%	021066	1	2004-12-23

US Patents and Regulatory Information for KETOTIFEN FUMARATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch And Lomb Inc	ALAWAY	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	208158-001	Sep 24, 2020		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Johnson Johnson Visn	ACUVUE THERAVISION WITH KETOTIFEN	ketotifen fumarate	DRUG-ELUTING CONTACT LENS;OPHTHALMIC	022388-001	Feb 25, 2022		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for KETOTIFEN FUMARATE

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Country	Patent Number	Title	Estimated Expiration
Canada	2646424	METHODS FOR STABILIZING OXIDATIVELY UNSTABLE COMPOSITIONS	⤷ Try a Trial
Japan	2010504984		⤷ Try a Trial
Japan	2009530314		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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