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Generated: April 26, 2019

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Nebivolol hydrochloride; valsartan - Generic Drug Details

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What are the generic sources for nebivolol hydrochloride; valsartan and what is the scope of nebivolol hydrochloride; valsartan freedom to operate?

Nebivolol hydrochloride; valsartan is the generic ingredient in one branded drug marketed by Allergan Sales Llc and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nebivolol hydrochloride; valsartan has thirty-seven patent family members in fifteen countries.

There are fourteen drug master file entries for nebivolol hydrochloride; valsartan. One supplier is listed for this compound.

Summary for nebivolol hydrochloride; valsartan
International Patents:37
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 14
Suppliers / Packagers: 1
Clinical Trials: 3
DailyMed Link:nebivolol hydrochloride; valsartan at DailyMed
Pharmacology for nebivolol hydrochloride; valsartan

US Patents and Regulatory Information for nebivolol hydrochloride; valsartan

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 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
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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Supplementary Protection Certificates for nebivolol hydrochloride; valsartan

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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