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Details for Generic Name: bimatoprost

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Bimatoprost is the generic ingredient in three branded drugs marketed by Alcon Res Ltd, Apotex Inc, Lupin Ltd, and Allergan, and is included in seven NDAs. There are twenty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has eigthy-four patent family members in twenty-four countries.

There are eleven drug master file entries for bimatoprost. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: bimatoprost

Drug Master File Entries: see list11
Suppliers / Packaging: see list16
Therapeutic Class:Ophthalmic Agents

Pharmacology for Ingredient: bimatoprost

Drug ClassProstaglandin Analog

Tentative approvals for BIMATOPROST

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; OPHTHALMIC0.03
<disabled><disabled>SOLUTION; OPHTHALMIC0.01%

Clinical Trials for: bimatoprost

Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
Status: Completed Condition: Alopecia Areata

Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes
Status: Completed Condition: Hypertrichosis

Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
Status: Completed Condition: Hypotrichosis

Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
Status: Completed Condition: Eyelash Hypotrichosis

Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
Status: Completed Condition: Eyelash Hypotrichosis

Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-Weeks, Masked Evaluator, Phase IV Multi-Center Study in the US
Status: Completed Condition: Glaucoma; Ocular Hypertension

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
SOLUTION/DROPS;TOPICAL201894-001Dec 1, 2014RXNo<disabled><disabled>
SOLUTION/DROPS;OPHTHALMIC022184-001Aug 31, 2010RXYes8,309,605<disabled> <disabled>
SOLUTION/DROPS;TOPICAL022369-001Dec 24, 2008RXYes8,541,466<disabled> <disabled>
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International Patent Family for Ingredient: bimatoprost

Country Document Number Publication Date
Netherlands300099Nov 01, 2002
Australia2003207843Apr 17, 2008
Canada2585691May 19, 2009
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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