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 |
Recent Clinical Trials for KETOTIFEN FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Peking University Third Hospital | Phase 4 |
EyeMax, LLC | Phase 3 |
Eton Pharmaceuticals, Inc. | Phase 3 |
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
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sentiss | KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 077958-001 | Jul 26, 2007 | OTC | No | 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 | ||||
Bayshore Pharms Llc | KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 204059-001 | Jun 1, 2020 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Johnson Johnson Visn | ACUVUE THERAVISION WITH KETOTIFEN | ketotifen fumarate | DRUG-ELUTING CONTACT LENS;OPHTHALMIC | 022388-001 | Feb 25, 2022 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
---|---|---|---|
Hong Kong | 1132176 | 用於使氧化不穩定的組合物穩定的方法 (STABILIZED OPHTHALMIC COMPOSITIONS COMPRISING OXIDATIVELY UNSTABLE COMPONENTS) | ⤷ Sign Up |
Japan | 5275214 | ⤷ Sign Up | |
China | 101541303 | Methods and ophthalmic devices used in the treatment of ocular allergies | ⤷ Sign Up |
European Patent Office | 2471507 | Dispositifs ophtalmiques utilisés dans le traitement d'allergies oculaires (Ophthalmic devices used in the treatment of ocular allergies) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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