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.
Seventeen 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: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 12 |
| Patent Applications: | 1,545 |
| Formulation / Manufacturing: | see details |
| 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 |
| 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Johnson Johnson Visn | ACUVUE THERAVISION WITH KETOTIFEN | ketotifen fumarate | DRUG-ELUTING CONTACT LENS;OPHTHALMIC | 022388-001 | Feb 25, 2022 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bausch And Lomb | CHILDREN'S ALAWAY | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 021996-002 | Feb 11, 2015 | OTC | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bausch And Lomb Inc | ALAWAY | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 208158-001 | Sep 24, 2020 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alcon Pharms Ltd | ZADITOR | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 077200-001 | Sep 2, 2008 | OTC | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bayshore Pharms Llc | KETOTIFEN FUMARATE | ketotifen fumarate | SOLUTION/DROPS;OPHTHALMIC | 204059-001 | Jun 1, 2020 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| Hungary | E033597 | ⤷ Try a Trial | |
| Argentina | 059928 | METODOS Y DISPOSITIVOS OFTALMICOS USADOS EN EL TRATAMIENTO DE ALERGIAS OCULARES | ⤷ Try a Trial |
| Japan | 2010504984 | ⤷ Try a Trial | |
| European Patent Office | 2471509 | Procédé de prévention de l'oxydation d'un dispositif ophtalmique comprenant un agent anti-allergique (Method of preventing oxidation of an ophthalmic device comprising an anti-allergic agent) | ⤷ Try a Trial |
| Argentina | 059927 | METODOS PARA LA ESTABILIZACION DE COMPOSICIONES INESTABLES A LA OXIDACION Y COMPOSICIONES OFTALMICAS ESTABILIZADAS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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