ZADITOR Drug Patent Profile

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When do Zaditor patents expire, and what generic alternatives are available?

Zaditor is a drug marketed by Alcon Pharma and Alcon Pharms Ltd and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zaditor

A generic version of ZADITOR was approved as ketotifen fumarate by APOTEX INC on May 9^th, 2006.

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Summary for ZADITOR

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	4
Patent Applications:	3,734
Drug Prices:	Drug price information for ZADITOR
DailyMed Link:	ZADITOR at DailyMed

Drug patent expirations by year for ZADITOR

Recent Clinical Trials for ZADITOR

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

Sponsor	Phase
Sen-Jam Pharmaceutical	Phase 2
National University, Singapore	Phase 2
EyeMax, LLC	Phase 3

See all ZADITOR clinical trials

Pharmacology for ZADITOR

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

Paragraph IV (Patent) Challenges for ZADITOR

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 ZADITOR

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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
Alcon Pharma	ZADITOR	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	021066-002	Oct 19, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alcon Pharms Ltd	ZADITOR	ketotifen fumarate	SOLUTION/DROPS;OPHTHALMIC	077200-001	Sep 2, 2008		OTC	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 ZADITOR

See the table below for patents covering ZADITOR around the world.

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Country	Patent Number	Title	Estimated Expiration
Hungary	230738	Ophthalmic composition comprising ketotifen	⤷ Sign Up
Japan	2003505419		⤷ Sign Up
Canada	2315767	COMPOSITIONS PHARMACEUTIQUES AUTOCLAVABLES, CONTENANT UN CHELATEUR (AUTOCLAVABLE PHARMACEUTICAL COMPOSITIONS CONTAINING A CHELATING AGENT)	⤷ Sign Up
Poland	352382		⤷ Sign Up
Denmark	1172098		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration