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Last Updated: November 2, 2024

KETOTIFEN FUMARATE Drug Patent Profile


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

Ketotifen Fumarate is a drug marketed by Apotex Inc, Bayshore Pharms Llc, and Sentiss. and is included in three NDAs.

The generic ingredient in KETOTIFEN FUMARATE 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 Ketotifen Fumarate

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

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Summary for KETOTIFEN FUMARATE
Drug patent expirations by year for KETOTIFEN FUMARATE
Drug Prices for KETOTIFEN FUMARATE

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Recent Clinical Trials for KETOTIFEN FUMARATE

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

SponsorPhase
Peking University Third HospitalPhase 4
EyeMax, LLCPhase 3
Eton Pharmaceuticals, Inc.Phase 3

See all KETOTIFEN FUMARATE clinical trials

Pharmacology for KETOTIFEN FUMARATE
Medical Subject Heading (MeSH) Categories for KETOTIFEN FUMARATE
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

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 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayshore Pharms Llc KETOTIFEN FUMARATE ketotifen fumarate SOLUTION/DROPS;OPHTHALMIC 204059-001 Jun 1, 2020 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sentiss KETOTIFEN FUMARATE ketotifen fumarate SOLUTION/DROPS;OPHTHALMIC 077958-001 Jul 26, 2007 OTC No No ⤷  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

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