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Generated: April 18, 2019

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BYVALSON Drug Profile

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

Byvalson is a drug marketed by Allergan Sales 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.

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.

Summary for BYVALSON
Drug patent expirations by year for BYVALSON
Generic Entry Opportunity Date for BYVALSON
Generic Entry Date for BYVALSON*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for BYVALSON
1268819-57-3
Nebivolol / valsartan
Nebivolol and valsartan
Nebivolol HCl mixture with valsartan
Nebivolol hydrochloride / valsartan
Nebivolol hydrochloride mixture with valsartan

US Patents and Regulatory Information for BYVALSON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan Sales Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan Sales Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for BYVALSON
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 5 mg/80 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for BYVALSON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 SPC/GB96/048 United Kingdom ➤ Sign Up PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
QuintilesIMS
Teva
Healthtrust
UBS
Deloitte

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