BIMATOPROST Drug Patent Profile
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Which patents cover Bimatoprost, and what generic alternatives are available?
Bimatoprost is a drug marketed by Alembic, Apotex, Eugia Pharma, Gland Pharma Ltd, Hikma, Lupin Ltd, Micro Labs, Sandoz, and Somerset Theraps Llc. and is included in thirteen NDAs.
The generic ingredient in BIMATOPROST is bimatoprost. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bimatoprost
A generic version of BIMATOPROST was approved as bimatoprost by APOTEX on December 1st, 2014.
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Questions you can ask:
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Summary for BIMATOPROST
Recent Clinical Trials for BIMATOPROST
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
SpyGlass Pharma, Inc. | Phase 1/Phase 2 |
Latham Fund | Phase 2 |
Medstar Health Research Institute | Phase 2 |
Pharmacology for BIMATOPROST
Drug Class | Prostaglandin Analog |
Medical Subject Heading (MeSH) Categories for BIMATOPROST
Anatomical Therapeutic Chemical (ATC) Classes for BIMATOPROST
Paragraph IV (Patent) Challenges for BIMATOPROST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LUMIGAN | Ophthalmic Solution | bimatoprost | 0.01% | 022184 | 1 | 2011-04-05 |
LATISSE | Topical Solution | bimatoprost | 0.03% | 022369 | 1 | 2010-05-03 |
LUMIGAN | Ophthalmic Solution | bimatoprost | 0.03% | 021275 | 1 | 2008-12-22 |
US Patents and Regulatory Information for BIMATOPROST
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alembic | BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 210263-001 | Apr 12, 2019 | AT | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Micro Labs | BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 202505-001 | Sep 8, 2020 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gland Pharma Ltd | BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 210126-001 | Mar 22, 2019 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | BIMATOPROST | bimatoprost | SOLUTION/DROPS;TOPICAL | 203051-001 | Oct 9, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sandoz | BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 202565-001 | May 5, 2015 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apotex | BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 090449-001 | Jul 20, 2015 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Eugia Pharma | BIMATOPROST | bimatoprost | SOLUTION/DROPS;OPHTHALMIC | 205537-001 | Oct 6, 2022 | AT | RX | 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 |
EU/EMA Drug Approvals for BIMATOPROST
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
AbbVie Deutschland GmbH & Co. KG | Lumigan | bimatoprost | EMEA/H/C/000391 Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers)., |
Authorised | no | no | no | 2002-03-08 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |