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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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and twenty-four patent family members in twenty-eight countries.

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

Summary for Generic Name: bromocriptine mesylate

Tradenames:3
Patents:9
Applicants:7
NDAs:8
Drug Master File Entries: see list9
Suppliers / Packaging: see list7
Therapeutic Class:Antiparkinson Agents
Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: bromocriptine mesylate

Ingredient-typeErgolines
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

Bromocriptine and Insulin Sensitivity
Status: Recruiting Condition: Insulin Sensitivity

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

Courtesy of ClinicalTrials.org
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
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes7,888,310<disabled><disabled>
Us Pharms Holdings I
PARLODEL
bromocriptine mesylate
TABLET;ORAL017962-001Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
Us Pharms Holdings I
PARLODEL
bromocriptine mesylate
CAPSULE;ORAL017962-002Mar 1, 1982RXYes<disabled><disabled>
Lek Pharms
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
TABLET;ORAL074631-001Jan 13, 1998RXNo<disabled><disabled>
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYes5,716,957<disabled><disabled>
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International Patent Family for Ingredient: bromocriptine mesylate

Country Document Number Publication Date
European Patent Office0735863Aug 20, 1997
Norway970038Jan 06, 1997
European Patent Office0772396Sep 10, 2003
Hungary9603543Feb 28, 1997
Norway965507Feb 11, 1997
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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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