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Bromocriptine mesylate - Generic Drug Details

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Bromocriptine mesylate is the generic ingredient in three branded drugs marketed by Lek Pharm, Mylan, Sandoz Inc, Paddock Llc, Us Pharms Holdings I, Veroscience, and Zydus Pharms Usa Inc, 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 nineteen patent family members in eleven countries.

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

Summary for Generic Name: bromocriptine mesylate

Tradenames:3
Patents:8
Applicants:7
NDAs:8
Drug Master File Entries: see list9
Suppliers / Packaging: see list10
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

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, 2009RXYes8,877,708<disabled>Y <disabled>
Mylan
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
TABLET;ORAL076962-001Sep 24, 2004RXNo<disabled><disabled>
Lek Pharm
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
CAPSULE;ORAL075100-001Dec 10, 1998DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: bromocriptine mesylate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,679,685<disabled>
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,468,755<disabled>
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,716,957<disabled>
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International Patent Family for Ingredient: bromocriptine mesylate

Country Document Number Estimated Expiration
China102458376<disabled in preview>
European Patent Office2844229<disabled in preview>
Argentina091351<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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