Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
AstraZeneca
Colorcon
Dow
McKesson

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

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 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.

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

See all nebivolol hydrochloride; valsartan clinical trials

Paragraph IV (Patent) Challenges for NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Tradename Dosage Ingredient NDA Submissiondate
BYVALSON TABLET;ORAL nebivolol hydrochloride; valsartan 206302 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
Allergan Sales Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan Sales Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan Sales Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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   Start 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Express Scripts
Merck
Moodys
Mallinckrodt

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