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Last Updated: November 22, 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.

Eighteen 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: 18
Raw Ingredient (Bulk) Api Vendors: 67
Clinical Trials: 12
Patent Applications: 1,527
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
Drug Prices for KETOTIFEN FUMARATE

See drug prices for KETOTIFEN FUMARATE

Recent Clinical Trials for KETOTIFEN FUMARATE

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

SponsorPhase
Peking University Third HospitalPhase 4
ORA, Inc.Phase 3
EyeMax, LLCPhase 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
Alcon Pharms Ltd ZADITOR ketotifen fumarate SOLUTION/DROPS;OPHTHALMIC 077200-001 Sep 2, 2008 OTC No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb ALAWAY ketotifen fumarate SOLUTION/DROPS;OPHTHALMIC 021996-001 Dec 1, 2006 OTC Yes Yes ⤷  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

International Patents for KETOTIFEN FUMARATE

Country Patent Number Title Estimated Expiration
European Patent Office 2010143 PROCÉDÉS DE STABILISATION DE COMPOSITIONS INSTABLES DE MANIÈRE OXYDATIVE (STABILIZED OPHTHALMIC COMPOSITIONS COMPRISING OXIDATIVELY UNSTABLE COMPONENTS) ⤷  Sign Up
Spain 2623532 ⤷  Sign Up
Spain 2624960 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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. 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.