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Details for Generic Name: bromocriptine mesylate

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

This ingredient has one hundred and fifteen patent family members in twenty-six countries.

There are nine drug master file entries for bromocriptine mesylate. Two suppliers are listed for this compound.

Summary for Generic Name: bromocriptine mesylate

Drug Master File Entries: see list9
Suppliers: see list2
Therapeutic Class:Antiparkinson Agents
Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: bromocriptine mesylate

Drug ClassErgot Derivative

Clinical Trials for: bromocriptine mesylate

Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects
Status: Recruiting Condition: Type 2 Diabetes

Effect of Cycloset on Glycemic Control When Added to GLP-1 Analogue Therapy
Status: Recruiting Condition: Type 2 Diabetes

Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg
Status: Completed Condition: Healthy

Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets
Status: Completed Condition: Healthy

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes8,137,994<disabled><disabled>
bromocriptine mesylate
CAPSULE;ORAL077226-001Apr 4, 2005RXNo<disabled><disabled>
Lek Pharm
bromocriptine mesylate
CAPSULE;ORAL075100-001Dec 10, 1998DISCNNo<disabled><disabled>
Zydus Pharms Usa Inc
bromocriptine mesylate
CAPSULE;ORAL078899-001Jul 30, 2008RXNo<disabled><disabled>
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes8,613,947<disabled>Y<disabled>
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International Patent Family for Ingredient: bromocriptine mesylate

Country Document Number Publication Date
Canada2193530Dec 28, 1995
World Intellectual Property Organization (WIPO)9518614Jul 13, 1995
Spain2126563Apr 01, 1999
Czech Republic282909Nov 12, 1997
Spain2186711May 16, 2003
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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