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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Express Scripts
Harvard Business School
Chubb
Federal Trade Commission
US Department of Justice
QuintilesIMS
Boehringer Ingelheim
Julphar
Cipla

Generated: August 23, 2017

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Dabrafenib mesylate - Generic Drug Details

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What are the generic drug sources for dabrafenib mesylate and what is the scope of dabrafenib mesylate freedom to operate?

Dabrafenib mesylate
is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dabrafenib mesylate has fifty-four patent family members in thirty-two countries.

There is one drug master file entry for dabrafenib mesylate. Two suppliers are listed for this compound.

Summary for Generic Name: dabrafenib mesylate

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list14
Clinical Trials: see list583
Patent Applications: see list31
Drug Prices:see low prices
DailyMed Link:dabrafenib mesylate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
TAFINLAR
dabrafenib mesylate
CAPSULE;ORAL202806-001May 29, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
TAFINLAR
dabrafenib mesylate
CAPSULE;ORAL202806-001May 29, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Novartis Pharms Corp
TAFINLAR
dabrafenib mesylate
CAPSULE;ORAL202806-002May 29, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
TAFINLAR
dabrafenib mesylate
CAPSULE;ORAL202806-002May 29, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
TAFINLAR
dabrafenib mesylate
CAPSULE;ORAL202806-001May 29, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dabrafenib 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
8,952,018Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors► Subscribe
8,642,759Benzene sulfonamide thiazole and oxazole compounds► 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: dabrafenib mesylate

Country Document Number Estimated Expiration
Serbia54725► Subscribe
Brazil112012008854► Subscribe
Dominican RepublicP2012000091► Subscribe
Peru19522009► Subscribe
HungaryE028820► 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:

Deloitte
Fish and Richardson
Chinese Patent Office
Julphar
Johnson and Johnson
Harvard Business School
US Army
Healthtrust
Daiichi Sankyo
UBS

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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