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Serving 500+ biopharmaceutical companies globally:

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Healthtrust
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Generated: June 28, 2017

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Bromocriptine mesylate - Generic Drug Details

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What are the generic sources for bromocriptine mesylate and what is the scope of bromocriptine mesylate patent protection?

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

Bromocriptine mesylate has twenty patent family members in twelve countries.

There are nine drug master file entries for bromocriptine mesylate. Thirteen 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 list13
Bulk Api Vendors: see list36
Clinical Trials: see list538
Patent Applications: see list6,376
Therapeutic Class: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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYesYes9,522,117► SubscribeY ► Subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 2009RXYesYes8,613,947► SubscribeY ► Subscribe
Sandoz Inc
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
TABLET;ORAL074631-001Jan 13, 1998ABRXNoNo► Subscribe► Subscribe
Paddock Llc
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
TABLET;ORAL077646-001Oct 1, 2008ABRXNoYes► Subscribe► Subscribe
Mylan
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
CAPSULE;ORAL077226-001Apr 4, 2005ABRXNoYes► Subscribe► 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
Us Pharms Holdings I
PARLODEL
bromocriptine mesylate
TABLET;ORAL017962-001Approved Prior to Jan 1, 19823,752,888► Subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,679,685► Subscribe
Us Pharms Holdings I
PARLODEL
bromocriptine mesylate
CAPSULE;ORAL017962-002Mar 1, 19823,752,814► Subscribe
Us Pharms Holdings I
PARLODEL
bromocriptine mesylate
TABLET;ORAL017962-001Approved Prior to Jan 1, 19823,752,814► Subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,716,957► 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
Japan2012529434► Subscribe
Hong Kong1208173► Subscribe
Japan5883382► Subscribe
China102458376► Subscribe
Australia2016202572► 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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Serving 500+ biopharmaceutical companies globally:

Novartis
Johnson and Johnson
US Army
QuintilesIMS
Federal Trade Commission
Merck
Colorcon
Medtronic
Baxter
Deloitte

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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