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Serving leading biopharmaceutical companies globally:

Novartis
Chinese Patent Office
QuintilesIMS
Healthtrust
Federal Trade Commission
Merck
US Department of Justice
Harvard Business School
Argus Health
Chubb

Generated: November 22, 2017

DrugPatentWatch Database Preview

BYSTOLIC Drug Profile

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Which patents cover Bystolic, and what generic Bystolic alternatives are available?

Bystolic is a drug marketed by Forest Labs and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in twenty-two countries and three supplementary protection certificates in three countries.

The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.

Summary for BYSTOLIC

Pharmacology for BYSTOLIC

Medical Subject Heading (MeSH) Categories for BYSTOLIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-002Dec 17, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-005Oct 8, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-003Dec 17, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-004Dec 17, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: BYSTOLIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-002Dec 17, 2007► Subscribe► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-005Oct 8, 2008► Subscribe► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-004Dec 17, 2007► Subscribe► Subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-003Dec 17, 2007► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for BYSTOLIC

Drugname Dosage Strength RLD Submissiondate
nebivolol hydrochlorideTablets2.5 mg, 5 mg, 10 mg, and 20 mgBystolic12/19/2011

International Patent Family for Tradename: BYSTOLIC

Country Document Number Estimated Expiration
Hungary211539► Subscribe
Ireland890906► Subscribe
Israel89691► Subscribe
Ireland62159► Subscribe
European Patent Office0334429► Subscribe
Luxembourg88842► Subscribe
Germany19675037► Subscribe
Spain2052881► Subscribe
Australia3074289► Subscribe
South Africa8902179► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BYSTOLIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
50031Netherlands► SubscribePRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
C/GB96/048United Kingdom► SubscribePRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Novartis
AstraZeneca
Cerilliant
Johnson and Johnson
Teva
Julphar
Covington
Deloitte

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 verifification 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.

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