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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Questions you can ask:
- What is the 5 year forecast for KETOTIFEN FUMARATE?
- What are the global sales for KETOTIFEN FUMARATE?
- What is Average Wholesale Price for KETOTIFEN FUMARATE?
Summary for KETOTIFEN FUMARATE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 12 |
| Patent Applications: | 1,095 |
| Drug Prices: | Drug price information 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 |
| ORA, Inc. | Phase 3 |
| EyeMax, LLC | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
