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Last Updated: October 22, 2020

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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, Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Hi-tech Pharma Co, Lupin Ltd, Micro Labs, Sandoz Inc, Somerset Theraps Llc, Allergan, and Hi Tech, and is included in sixteen NDAs. There are thirty-three 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 forty patent family members in thirty-three countries.

There are twelve drug master file entries for bimatoprost. Eight suppliers are listed for this compound. There are four 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
Sun Pharma Global FZEPhase 3
Laboratoires TheaPhase 3
Manistee PartnersPhase 2

See all bimatoprost clinical trials

Generic filers with tentative approvals for BIMATOPROST
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.03SOLUTION; OPHTHALMIC
  Start Trial  Start Trial0.01%SOLUTION; OPHTHALMIC
  Start Trial  Start Trial0.01%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 NDA Submissiondate
LUMIGAN SOLUTION/DROPS;OPHTHALMIC bimatoprost 022184 2011-04-05
LATISSE SOLUTION/DROPS;TOPICAL bimatoprost 022369 2010-05-03
LUMIGAN SOLUTION/DROPS;OPHTHALMIC bimatoprost 021275 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
Hi Tech BIMATOPROST bimatoprost SOLUTION/DROPS;TOPICAL 203051-001 Oct 9, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Inc DURYSTA bimatoprost IMPLANT;OPHTHALMIC 211911-001 Mar 4, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Inc DURYSTA bimatoprost IMPLANT;OPHTHALMIC 211911-001 Mar 4, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 Inc DURYSTA bimatoprost IMPLANT;OPHTHALMIC 211911-001 Mar 4, 2020   Start Trial   Start Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 021275-001 Mar 16, 2001   Start Trial   Start Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 021275-001 Mar 16, 2001   Start Trial   Start Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010   Start Trial   Start Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for bimatoprost

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

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