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Last Updated: January 30, 2023

Bimatoprost - Generic Drug Details


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What are the generic drug sources for bimatoprost and what is the scope of patent protection?

Bimatoprost is the generic ingredient in four branded drugs marketed by Allergan Inc, Akorn, Alembic Pharms Ltd, Apotex Inc, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Micro Labs, Sandoz Inc, Somerset Theraps Llc, and Allergan, and is included in seventeen NDAs. There are twenty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bimatoprost has two hundred and twenty-five patent family members in thirty-four countries.

There are twelve drug master file entries for bimatoprost. Eleven suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for bimatoprost

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Drug Sales Revenue Trends for bimatoprost

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Recent Clinical Trials for bimatoprost

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Amneal Pharmaceuticals, LLCPhase 3
Medical University of South CarolinaEarly Phase 1
Mankind Pharma LimitedPhase 3

See all bimatoprost clinical trials

Generic filers with tentative approvals for BIMATOPROST
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing0.03SOLUTION; OPHTHALMIC
See Plans and PricingSee Plans and Pricing0.01%SOLUTION; OPHTHALMIC
See Plans and PricingSee Plans and Pricing0.01%SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bimatoprost
Medical Subject Heading (MeSH) Categories 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
Sandoz Inc BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 202565-001 May 5, 2015 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Apotex Inc BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 090449-001 Jul 20, 2015 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for bimatoprost

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 021275-001 Mar 16, 2001 See Plans and Pricing See Plans and Pricing
Allergan Inc DURYSTA bimatoprost IMPLANT;OPHTHALMIC 211911-001 Mar 4, 2020 See Plans and Pricing See Plans and Pricing
Allergan LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369-001 Dec 24, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

International Patents for bimatoprost

Country Patent Number Title Estimated Expiration
South Africa 201203883 7-[3,5-DIHYDROXY-2-(3-HYDROXY-5-PHENYL-PENT-1-ENYL)-CYCLOPENTYL]-N-ETHYL-HEPT-5-ENAMIDE (BIMATOPROST)IN CRYSTALLINE FORM II, METHODS FOR PREPARATION, AND METHODS FOR USE THEREOF See Plans and Pricing
Spain 2657143 See Plans and Pricing
Poland 2558081 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bimatoprost

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0660716 02C0033 France See Plans and Pricing PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
0660716 SPC/GB02/035 United Kingdom See Plans and Pricing PRODUCT NAME: BIMATOPROST; REGISTERED: UK EU/1/02/205/001 20020308
0660716 C300099 Netherlands See Plans and Pricing PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION: EU/1/02/205/001 20020308
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.