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Last Updated: September 25, 2022

BYVALSON Drug Patent Profile


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Which patents cover Byvalson, and when can generic versions of Byvalson launch?

Byvalson is a drug marketed by Allergan 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. Additional details are available on the nebivolol hydrochloride; valsartan profile page.

DrugPatentWatch® Generic Entry Outlook for Byvalson

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 29, 2026. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for BYVALSON
Drug Prices for BYVALSON

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for BYVALSON
Generic Entry Date for BYVALSON*:
Constraining patent/regulatory exclusivity:
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.

Paragraph IV (Patent) Challenges for BYVALSON
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 BYVALSON

BYVALSON is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYVALSON is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BYVALSON

Compositions comprising nebivolol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions comprising nebivolol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING HYPERTENSION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 BYVALSON

When does loss-of-exclusivity occur for BYVALSON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 15
Estimated Expiration: See Plans and Pricing

Patent: 96
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05249514
Estimated Expiration: See Plans and Pricing

Patent: 05332300
Estimated Expiration: See Plans and Pricing

Austria

Patent: 9627
Estimated Expiration: See Plans and Pricing

Canada

Patent: 69881
Estimated Expiration: See Plans and Pricing

Patent: 10694
Estimated Expiration: See Plans and Pricing

China

Patent: 1022791
Estimated Expiration: See Plans and Pricing

Patent: 1242827
Estimated Expiration: See Plans and Pricing

Patent: 2188708
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 53418
Estimated Expiration: See Plans and Pricing

Patent: 90691
Estimated Expiration: See Plans and Pricing

Patent: 82711
Estimated Expiration: See Plans and Pricing

Patent: 74658
Estimated Expiration: See Plans and Pricing

Patent: 08015
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 04570
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9999
Estimated Expiration: See Plans and Pricing

Patent: 7552
Estimated Expiration: See Plans and Pricing

Japan

Patent: 08545742
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1910
Estimated Expiration: See Plans and Pricing

Patent: 3759
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 03037
Estimated Expiration: See Plans and Pricing

Patent: 41653
Estimated Expiration: See Plans and Pricing

Patent: 93335
Estimated Expiration: See Plans and Pricing

Patent: 06147220
Estimated Expiration: See Plans and Pricing

Patent: 07148414
Estimated Expiration: See Plans and Pricing

Patent: 10130950
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 2255
Estimated Expiration: See Plans and Pricing

Patent: 2734
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0610708
Estimated Expiration: See Plans and Pricing

Patent: 0710355
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1236166
Estimated Expiration: See Plans and Pricing

Patent: 1310037
Estimated Expiration: See Plans and Pricing

Patent: 070044833
Estimated Expiration: See Plans and Pricing

Patent: 080025699
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BYVALSON around the world.

Country Patent Number Title Estimated Expiration
Japan 2008545742 See Plans and Pricing
South Korea 101236166 See Plans and Pricing
Canada 2610694 COMPOSITIONS A BASE DE NEBIVOLOL (COMPOSITIONS COMRISING NEBIVOLOL) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005117858 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYVALSON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 SPC/GB96/048 United Kingdom See Plans and Pricing 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:

Dow
Boehringer Ingelheim
Johnson and Johnson
McKinsey
Moodys
Baxter

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.