BIMATOPROST - Generic Drug Details

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

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. Twelve 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:	12
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	130
Patent Applications:	6,597
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
⤷ Sign Up	⤷ Sign Up	0.03	SOLUTION; OPHTHALMIC
⤷ Sign Up	⤷ Sign Up	0.01%	SOLUTION; OPHTHALMIC
⤷ Sign Up	⤷ Sign Up	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
Sandoz	BIMATOPROST	bimatoprost	SOLUTION/DROPS;TOPICAL	202719-001	Apr 19, 2016	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	090449-001	Jul 20, 2015	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	BIMATOPROST	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	207601-001	Jun 19, 2019	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	⤷ Sign Up	⤷ Sign Up
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	⤷ Sign Up	⤷ Sign Up
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	021275-001	Mar 16, 2001	⤷ Sign Up	⤷ Sign Up
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	021275-001	Mar 16, 2001	⤷ Sign Up	⤷ Sign Up
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	⤷ Sign Up	⤷ Sign Up
>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
Australia	2022200742	Prostamide-containing intraocular implants and methods of use thereof	⤷ Sign Up
European Patent Office	1944032	Implants intraoculaires biodégradables contenant des prostamides (Biodegradable intraocular implants containing prostamides)	⤷ Sign Up
Slovenia	3351239		⤷ Sign Up
South Korea	20120085330	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	⤷ Sign Up
Canada	2673294	PROCEDES DE FABRICATION D'IMPLANTS LIPIDES CYCLIQUES POUR UTILISATION INTRAOCULAIRE (PROCESSES FOR MAKING CYCLIC LIPID IMPLANTS FOR INTRAOCULAR USE)	⤷ Sign Up
>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	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: BIMATOPROST; REGISTERED: UK EU/1/02/205/001 20020308
0660716	02C0033	France	⤷ Sign Up	PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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