Last Updated: June 23, 2026

KETOTIFEN Drug Patent Profile

Name: KETOTIFEN Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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When do Ketotifen patents expire, and when can generic versions of Ketotifen launch?

Ketotifen is a drug marketed by Apotex Inc, Sentiss, and Unichem. and is included in three NDAs.

The generic ingredient in KETOTIFEN is ketotifen fumarate. There are five drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ketotifen

A generic version of KETOTIFEN was approved as ketotifen fumarate by SENTISS on July 26^th, 2007.

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Summary for KETOTIFEN

US Patents:	0
Applicants:	3
NDAs:	3
Drug Prices:	Drug price information for KETOTIFEN
DailyMed Link:	KETOTIFEN at DailyMed

Drug patent expirations by year for KETOTIFEN

US Patents and Regulatory Information for KETOTIFEN

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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
Apotex Inc	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077354-001	May 9, 2006		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sentiss	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077958-001	Jul 26, 2007		OTC	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Unichem	KETOTIFEN FUMARATE	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	204059-001	Jun 1, 2020		OTC	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

DrugChatter Q&A for KETOTIFEN

Ketotifen fumarate tablets?
Ketotifen hydrogen fumarate?
What is ketotifen fumarate?
Ketotifen eye drops vs pataday?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.