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 Abbvie, Alembic, Apotex, Eugia Pharma, Gland Pharma Ltd, Hikma, Lupin Ltd, Micro Labs, Sandoz, and Somerset Theraps Llc, and is included in seventeen NDAs. There are twenty-two 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-eight patent family members in thirty-five 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.

Summary for bimatoprost

International Patents:	228
US Patents:	22
Tradenames:	4
Applicants:	10
NDAs:	17
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	130
Patent Applications:	6,684
Drug Prices:	Drug price trends for bimatoprost
Drug Sales Revenues:	Drug sales revenues for bimatoprost
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bimatoprost
What excipients (inactive ingredients) are in bimatoprost?	bimatoprost excipients list
DailyMed Link:	bimatoprost at DailyMed

See drug prices for bimatoprost

Drug Sales Revenue Trends for bimatoprost

See drug sales revenues 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

See all bimatoprost clinical trials

Generic filers with tentative approvals for BIMATOPROST

Applicant	Application No.	Strength	Dosage Form
⤷ Subscribe	⤷ Subscribe	0.03	SOLUTION; OPHTHALMIC
⤷ Subscribe	⤷ Subscribe	0.01%	SOLUTION; OPHTHALMIC
⤷ Subscribe	⤷ Subscribe	0.01%	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

Drug Class	Prostaglandin Analog

Medical Subject Heading (MeSH) Categories for bimatoprost

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for bimatoprost

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010	⤷ Subscribe	⤷ Subscribe
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	⤷ Subscribe	⤷ Subscribe
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	⤷ Subscribe	⤷ Subscribe
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for bimatoprost

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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

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1207570	晶型 -二羥基- -羥基- -苯基-戊- -烯基 -環戊基 -乙基-庚- -烯酰胺比馬前列素、其製備方法和使用方法 (7-[3,5-DIHYDROXY-2-(3-HYDROXY-5-PHENYL-PENT-1-ENYL)-CYCLOPENTYL]-N- ETHYL-HEPT-4-ENAMIDE (BIMATOPROST) IN CRYSTALLINE FORM II, METHODS FOR PREPARATION, AND METHODS FOR USE THEREOF II 7-[35--2-(3--5---1-)-]-N-- -5-())	⤷ Subscribe
Japan	2016094471	結晶形態ＩＩの７−［３，５−ジヒドロキシ−２−（３−ヒドロキシ−５−フェニル−ペント−１−エニル）−シクロペンチル］−Ｎ−エチル−ヘプト−５−エナミド（ビマトプロスト）、その調製方法、およびその使用方法 (7-[3,5-DIHYDROXY-2-(3-HYDROXY-5-PHENYL-PENT-1-ENYL)-CYCLOPENTYL]-N-ETHYL-HEPT-5-ENAMIDE (BIMATOPROST) IN CRYSTALLINE FORM II, METHOD FOR PREPARATION, AND METHOD FOR USE THEREOF)	⤷ Subscribe
Cyprus	1119961		⤷ Subscribe
Brazil	112012026535	redução de pressão intraocular com implantes de bimatoprost intracameral	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for bimatoprost

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