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Last Updated: May 10, 2024

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. Eight 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:	8
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	6
Patent Applications:	5,197
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
Case Western Reserve University	Phase 1/Phase 2
Andrew Moshfeghi, MD, MBA	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

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
Zydus Pharms Usa Inc	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	CAPSULE;ORAL	078899-001	Jul 30, 2008	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	TABLET;ORAL	074631-001	Jan 13, 1998	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a 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 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	⤷ Try a Trial	⤷ Try a Trial
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	⤷ Try a Trial	⤷ Try a Trial
Ss Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	⤷ Try a Trial	⤷ Try a Trial
Ss Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>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
Japan	5883382		⤷ Try a Trial
European Patent Office	2437732	ASSOCIATION ENTRE AGONISTES DE LA DOPAMINE ET SÉCRÉTAGOGUES D'INSULINE DE PHASE 1, DESTINÉE AU TRAITEMENT DE TROUBLES DU MÉTABOLISME (COMBINATION OF DOPAMINE AGONISTS PLUS FIRST PHASE INSULIN SECRETAGOUGES FOR THE TREATMENT OF METABOLIC DISORDERS)	⤷ Try a Trial
Brazil	PI1009619	método para tratar um distúrbio metabólico ou elementos chaves de um distúrbio metabólico e forma de dosagem farmacêutica	⤷ Try a Trial
Spain	2682644		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2013165902		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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