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 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
International Patents: | 37 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Clinical Trials: | 4 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for nebivolol hydrochloride; valsartan |
DailyMed Link: | nebivolol hydrochloride; valsartan at DailyMed |
Recent Clinical Trials for nebivolol hydrochloride; valsartan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Allergan Sales, LLC | Phase 4 |
Trinity Hypertension & Metabolic Research Institute | Phase 4 |
State University of New York at Buffalo | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for nebivolol hydrochloride; valsartan
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | BYVALSON | nebivolol hydrochloride; valsartan | TABLET;ORAL | 206302-001 | Jun 3, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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 | |||
>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 |
---|---|---|---|
China | 101242827 | Compositions comprising nebivolol | ⤷ Try a Trial |
Canada | 2610694 | COMPOSITIONS A BASE DE NEBIVOLOL (COMPOSITIONS COMRISING NEBIVOLOL) | ⤷ Try a Trial |
European Patent Office | 1753418 | COMPOSITIONS COMPRENANT DU NÉBIVOLOL (COMPOSITIONS COMPRISING NEBIVOLOL) | ⤷ Try a Trial |
European Patent Office | 2174658 | Compositions comportant du nebivolol (Compositions comprising nebivolol) | ⤷ Try a Trial |
Russian Federation | 2007148414 | КОМПОЗИЦИИ, СОДЕРЖАЩИЕ НЕБИВОЛОЛ | ⤷ Try a Trial |
Japan | 2008545742 | ⤷ 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 |