BROMOCRIPTINE MESYLATE - Generic Drug Details

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

Bromocriptine mesylate is the generic ingredient in three branded drugs marketed by Lek Pharm, Mylan, Zydus Pharms Usa Inc, Ss Pharma, Aurobindo Pharma Usa, Padagis Us, Sandoz, and Veroscience, and is included in eight NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bromocriptine mesylate has thirty-two patent family members in thirteen countries.

There are eight drug master file entries for bromocriptine mesylate. Nine suppliers are listed for this compound.

Summary for BROMOCRIPTINE MESYLATE

International Patents:	32
US Patents:	12
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	6
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for BROMOCRIPTINE MESYLATE
What excipients (inactive ingredients) are in BROMOCRIPTINE MESYLATE?	BROMOCRIPTINE MESYLATE excipients list
DailyMed Link:	BROMOCRIPTINE MESYLATE at DailyMed

See drug prices for BROMOCRIPTINE MESYLATE

Recent Clinical Trials for BROMOCRIPTINE MESYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Andrew Moshfeghi, MD, MBA	Phase 1/Phase 2
Case Western Reserve University	Phase 1/Phase 2
VeroScience	Phase 1

See all BROMOCRIPTINE MESYLATE clinical trials

Pharmacology for BROMOCRIPTINE MESYLATE

Drug Class	Ergot Derivative

Medical Subject Heading (MeSH) Categories for BROMOCRIPTINE MESYLATE

Antiparkinson Agents
Dopamine Agonists
Hormone Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for BROMOCRIPTINE MESYLATE

G02CB	Prolactine inhibitors
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for BROMOCRIPTINE MESYLATE

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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
Mylan	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	CAPSULE;ORAL	077226-001	Apr 4, 2005	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	TABLET;ORAL	074631-001	Jan 13, 1998	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	TABLET;ORAL	076962-001	Sep 24, 2004		DISCN	No	No	⤷ 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 BROMOCRIPTINE MESYLATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	⤷ Sign Up	⤷ Sign Up
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	⤷ Sign Up	⤷ Sign Up
Ss Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982	⤷ Sign Up	⤷ Sign Up
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	⤷ Sign Up	⤷ Sign Up
Ss Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BROMOCRIPTINE MESYLATE

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Country	Patent Number	Title	Estimated Expiration
Australia	2013256558	Bromocriptine formulations	⤷ Sign Up
Brazil	PI1009619	método para tratar um distúrbio metabólico ou elementos chaves de um distúrbio metabólico e forma de dosagem farmacêutica	⤷ Sign Up
European Patent Office	4342536	FORMULATIONS DE BROMOCRIPTINE (BROMOCRIPTINE FORMULATIONS)	⤷ Sign Up
Japan	2012529434		⤷ Sign Up
Spain	2755081		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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