Ketotifen fumarate - Generic Drug Details
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What are the generic drug 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
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
International Patents for ketotifen fumarate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 104614873 | METHODS AND OPHTHALMIC DEVICES USED IN THE TREATMENT OF OCULAR ALLERGIES | ⤷ Try a Trial |
European Patent Office | 2471508 | Procédé de préparation d'un dispositif ophtalmique utilisé dans le traitement d'allergies oculaires (Method of making an ophthalmic device used in the treatment of ocular allergies) | ⤷ Try a Trial |
Russian Federation | 2008141172 | СПОСОБЫ СТАБИЛИЗАЦИИ ОКИСЛИТЕЛЬНО НЕСТАБИЛЬНЫХ КОМПОЗИЦИЙ | ⤷ Try a Trial |
Taiwan | I454286 | ⤷ Try a Trial | |
Brazil | PI0718374 | mÉtodos e dispositivos oftÁlmicos usados no tratamento de alergias oculares | ⤷ Try a Trial |
China | 101420934 | Methods for stabilizing oxidatively unstable compositions | ⤷ Try a Trial |
Taiwan | 200815005 | Methods and ophthalmic devices used in the treatment of ocular allergies | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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