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Generated: June 16, 2019

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BIMATOPROST - Generic Drug Details

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What are the generic sources for bimatoprost and what is the scope of bimatoprost freedom to operate?

Bimatoprost is the generic ingredient in three branded drugs marketed by Apotex Inc, Hi-tech Pharma Co, Lupin Ltd, Sandoz Inc, Allergan, and Hi-tech Pharmacal, and is included in ten 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-seven patent family members in twenty-two countries.

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

Pharmacology for BIMATOPROST
Ingredient-typeProstaglandins
Drug ClassProstaglandin Analog
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
Generic filers with tentative approvals for BIMATOPROST
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial0.03SOLUTION; OPHTHALMIC
➤ Try a Free Trial➤ Try a Free Trial0.01%SOLUTION; OPHTHALMIC
➤ Try a Free Trial➤ Try a Free 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.

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;TOPICAL 202719-001 Apr 19, 2016 AT RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allergan LATISSE bimatoprost SOLUTION/DROPS;TOPICAL 022369-001 Dec 24, 2008 AT RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc BIMATOPROST bimatoprost SOLUTION/DROPS;OPHTHALMIC 202565-001 May 5, 2015 AT RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hi-tech Pharmacal BIMATOPROST bimatoprost SOLUTION/DROPS;TOPICAL 203051-001 Oct 9, 2018 AT RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan LUMIGAN bimatoprost SOLUTION/DROPS;OPHTHALMIC 022184-001 Aug 31, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for BIMATOPROST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0660716 02C0033 France ➤ Try a Free Trial PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
0660716 C300099 Netherlands ➤ Try a Free 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 ➤ Try a Free 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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