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-three 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:	33
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
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
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	Y			⤷ Sign Up
Padagis Us	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	TABLET;ORAL	077646-001	Oct 1, 2008	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	Y			⤷ 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
Ss Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982	⤷ 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
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	⤷ 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
Canada	2872300		⤷ Sign Up
Spain	2682644		⤷ Sign Up
European Patent Office	3375437	COMBINAISON D'AGONISTES DE LA DOPAMINE ET DE SÉCRÉTAGOGUES D'INSULINE DE PHASE 1 POUR LE TRAITEMENT DE TROUBLES MÉTABOLIQUES (COMBINATION OF DOPAMINE AGONISTS PLUS FIRST PHASE INSULIN SECRETAGOUGES FOR THE TREATMENT OF METABOLIC DISORDERS)	⤷ Sign Up
Argentina	091351	FORMULACIONES DE BROMOCRIPTINA, METODO PARA MEJORAR EL CONTROL GLUCEMICO Y METODO PARA LA FABRICACION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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