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Bromocriptine mesylate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for bromocriptine mesylate?

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 nine 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. Eleven suppliers are listed for this compound.

Summary for Generic Name: bromocriptine mesylate

Tradenames:3
Patents:10
Applicants:7
NDAs:8
Drug Master File Entries: see list9
Suppliers / Packagers: see list11
Bulk Api Vendors: see list35
Clinical Trials: see list184
Patent Applications: see list5,272
Therapeutic Class:Antiparkinson Agents
Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bromocriptine mesylate at DailyMed

Pharmacology for Ingredient: bromocriptine mesylate

Ingredient-typeErgolines
Drug ClassErgot Derivative
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYesYes8,613,947► SubscribeY ► Subscribe
Lek Pharm
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
CAPSULE;ORAL075100-001Dec 10, 1998DISCNNoNo► Subscribe► Subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYesYes8,137,994► Subscribe ► Subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYesYes7,888,310► Subscribe ► Subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYesYes8,431,155► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: bromocriptine mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,468,755► Subscribe
Us Pharms Holdings I
PARLODEL
bromocriptine mesylate
CAPSULE;ORAL017962-002Mar 1, 19823,752,814► Subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,716,957► Subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,756,513► Subscribe
Us Pharms Holdings I
PARLODEL
bromocriptine mesylate
TABLET;ORAL017962-001Approved Prior to Jan 1, 19823,752,888► Subscribe
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Non-Orange Book Patents for Generic Ingredient: bromocriptine mesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,352,025Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bromocriptine mesylate

Country Document Number Estimated Expiration
Hong Kong1208173► Subscribe
Japan5883382► Subscribe
Japan2012529434► Subscribe
Argentina091351► Subscribe
Uruguay34776► Subscribe
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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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