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Last Updated: November 15, 2019

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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 freedom to operate?

Bimatoprost is the generic ingredient in three branded drugs marketed by Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Hi-tech Pharma Co, Lupin Ltd, Sandoz Inc, Somerset Theraps Llc, Allergan, and Hi Tech, and is included in thirteen NDAs. There are twenty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bimatoprost has sixty-eight patent family members in twenty-two 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

Recent Litigation for bimatoprost

Identify potential future generic entrants

District Court Litigation
Case NameDate
DUKE UNIVERSITY v. AKORN, INC.2018-09-19
Duke University v. Alcon Laboratories, Inc.2018-05-01
Duke University v. Sandoz Inc.2018-04-26

See all bimatoprost litigation

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
Synonyms for bimatoprost
(5Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenylpent-1-en-1-yl]cyclopentyl]-N-ethylhept-5-enamide
(5Z)-7-{(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenylpent-1-en-1-yl]cyclopentyl}-N-ethylhept-5-enamide
(5z)-7-{(1r,2r,3r,5s)-3,5-Dihydroxy-2-[(1e,3s)-3-Hydroxy-5-Phenylpent-1-Enyl]cyclopentyl}-N-Ethylhept-5-Enamide
(E)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(E,3S)-3-hydroxy-5-phenylpent-1-enyl]cyclopentyl]-N-ethylhept-5-enamide
(Z)-7-((1R,2R,3R,5S)-3,5-Dihydroxy-2-((1E,3S)-3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-N-ethyl-5-heptenamide
(Z)-7-((1R,2R,3R,5S)-3,5-dihydroxy-2-((S,E)-3-hydroxy-5-phenylpent-1-en-1-yl)cyclopentyl)-N-ethylhept-5-enamide
(Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(E,3S)-3-hydroxy-5-phenyl-pent-1-enyl]cyclopentyl]-N-ethyl-hept-5-enamide
(Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(E,3S)-3-hydroxy-5-phenylpent-1-enyl]cyclopentyl]-N-ethylhept-5-enamide
155206-00-1
15M
17-PHENYL TRINOR PROSTAGLANDIN F2ALPHA ETHYL AMIDE
17-Phenyl-tri-norprostaglandin F2alpha-ethyl amide
17-Phenyl-tri-norprostaglandin F2alpha-ethyl amide, >=95%, solid
206B001
267244-98-4
5-Heptenamide, 7-((1R,2R,3R,5S)-3,5-dihydroxy-2-((1E,3S)-3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-N-ethyl-, (5Z)-
5-Heptenamide, 7-(3,5-dihydroxy-2-(3-hydrdoxy-5-phenyl-1-pentenyl)cyclopentyl)-N-ethyl-, (1R-(1alpha(Z),2beta(1E,3S*),3alpha,5alpha))-
5-Heptenamide, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-N-ethyl-, (1R-1(alpha(Z),2beta(1E,3S*)3alpha,5alpha))-
5-Heptenamide,7-((1R,2R,3R,5S)-3,5-dihydroxy-2-((1E,3S)-3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-N-ehtyl-,(5Z)
AB0015029
ABP000616
AC1NSJUW
AGN 192024
AGN-192024
AK173142
AKOS015995566
AM84507
AN-5283
AQOKCDNYWBIDND-FTOWTWDKSA-N
AS-35082
BDBM220120
Bimataprost [USAN:INN:BAN]
Bimatoprost (JAN/USAN/INN)
Bimatoprost [USAN:INN:BAN:JAN]
Bimatoprost/Lumigan
bimatoprostum
CHEBI:51230
CHEMBL1200963
CS-2085
D02724
DB00905
EX-A1769
GTPL1958
HY-B0191
I06-1275
I06-1277
Latisse
Latisse (TN)
LS-181817
Lumigan
Lumigan (TN)
M052
MLS006010039
MolPort-006-167-657
NCGC00181745-01
QXS94885MZ
RP17728
SCHEMBL24425
SMR000058996
SR-01000942224
SR-01000942224-1
UNII-QXS94885MZ
US9271961, Bimatoprost
ZINC4474405
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
Allergan LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369-001 Dec 24, 2008 AT 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   Start Trial
Hi-tech Pharma Co BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 203299-001 Nov 8, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Allergan LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369-001 Dec 24, 2008 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369-001 Dec 24, 2008 AT 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
Hi Tech BIMATOPROST bimatoprost SOLUTION/DROPS;TOPICAL 203051-001 Oct 9, 2018 AT RX No No   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 LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010   Start Trial   Start Trial
Allergan LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369-001 Dec 24, 2008   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 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 LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369-001 Dec 24, 2008   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 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 02C0033 France   Start Trial PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
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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Harvard Business School
Medtronic
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Colorcon

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