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Serving leading biopharmaceutical companies globally:

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McKesson
US Army
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Generated: December 18, 2017

DrugPatentWatch Database Preview

BYVALSON Drug Profile

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Which patents cover Byvalson, and what generic alternatives are available?

Byvalson is a drug marketed by Forest Labs Llc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in fifteen countries and one supplementary protection certificate in one country.

The generic ingredient in BYVALSON is nebivolol hydrochloride; valsartan. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nebivolol hydrochloride; valsartan profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs LlcBYVALSONnebivolol hydrochloride; valsartanTABLET;ORAL206302-001Jun 3, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Forest Labs LlcBYVALSONnebivolol hydrochloride; valsartanTABLET;ORAL206302-001Jun 3, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Forest Labs LlcBYVALSONnebivolol hydrochloride; valsartanTABLET;ORAL206302-001Jun 3, 2016RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for BYVALSON

Drugname Dosage Strength RLD Submissiondate
nebivolol hydrochloride and valsartanTablets5 mg/80 mgByvalson6/9/2017

International Patent Family for Tradename: BYVALSON

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2006130174► Subscribe
Russian Federation2593335► Subscribe
European Patent Office2174658► Subscribe
Hong Kong1204570► Subscribe
New Zealand563759► Subscribe
China101022791► Subscribe
Russian Federation2403037► Subscribe
Austria509627► Subscribe
Australia2005249514► Subscribe
European Patent Office1890691► 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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Supplementary Protection Certificates for Tradename: BYVALSON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB96/048United Kingdom► SubscribePRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
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Serving leading biopharmaceutical companies globally:

Fuji
Farmers Insurance
Mallinckrodt
UBS
Boehringer Ingelheim
Express Scripts
Federal Trade Commission
Queensland Health
AstraZeneca
McKesson

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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