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Last Updated: March 28, 2024

Nebivolol hydrochloride; valsartan - Generic Drug Details


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

Nebivolol hydrochloride; valsartan is the generic ingredient in two branded drugs marketed by Abbvie and Prinston Inc, and is included in two NDAs. 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.

Summary for nebivolol hydrochloride; valsartan
Recent Clinical Trials for nebivolol hydrochloride; valsartan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Trinity Hypertension & Metabolic Research InstitutePhase 4
Allergan Sales, LLCPhase 4
State University of New York at BuffaloPhase 3

See all nebivolol hydrochloride; valsartan clinical trials

Paragraph IV (Patent) Challenges for NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BYVALSON Tablets nebivolol hydrochloride; valsartan 5 mg/80 mg 206302 1 2017-06-09

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
Prinston Inc VYDUO nebivolol hydrochloride; valsartan TABLET;ORAL 210596-001 Sep 19, 2022 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for nebivolol hydrochloride; valsartan

Country Patent Number Title Estimated Expiration
Russian Federation 2006147220 КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ В СЕБЯ НЕБИВОЛОЛ ⤷  Try a Trial
South Korea 20070044833 COMPOSITIONS COMPRISING NEBIVOLOL ⤷  Try a Trial
New Zealand 551910 Compositions comprising nebivolol and an angiotensin II receptor antagonist (ARB) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for nebivolol hydrochloride; valsartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 SPC/GB96/048 United Kingdom ⤷  Try a Trial 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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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 verification 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.