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Last Updated: May 29, 2024

BYSTOLIC Drug Patent Profile


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When do Bystolic patents expire, and when can generic versions of Bystolic launch?

Bystolic is a drug marketed by Allergan and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Bystolic

A generic version of BYSTOLIC was approved as nebivolol hydrochloride by ANI PHARMS on April 16th, 2015.

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Drug patent expirations by year for BYSTOLIC
Drug Prices for BYSTOLIC

See drug prices for BYSTOLIC

Drug Sales Revenue Trends for BYSTOLIC

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Recent Clinical Trials for BYSTOLIC

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

SponsorPhase
Massachusetts General HospitalPhase 4
Martin M. Miner, MDPhase 4
State University of New York at BuffaloPhase 3

See all BYSTOLIC clinical trials

Pharmacology for BYSTOLIC
Paragraph IV (Patent) Challenges for BYSTOLIC
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BYSTOLIC Tablets nebivolol hydrochloride 2.5 mg, 5 mg, 10 mg, and 20 mg 021742 7 2011-12-19

US Patents and Regulatory Information for BYSTOLIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-002 Dec 17, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-005 Oct 8, 2008 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-004 Dec 17, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BYSTOLIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007 ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-002 Dec 17, 2007 ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-004 Dec 17, 2007 ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-005 Oct 8, 2008 ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-005 Oct 8, 2008 ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007 ⤷  Sign Up ⤷  Sign Up
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-002 Dec 17, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BYSTOLIC

See the table below for patents covering BYSTOLIC around the world.

Country Patent Number Title Estimated Expiration
Finland 963227 ⤷  Sign Up
China 1140991 ⤷  Sign Up
Canada 1337432 METHODE DE REDUCTION DE LA TENSION ARTERIELLE (METHOD OF LOWERING THE BLOOD PRESSURE) ⤷  Sign Up
Ireland 62159 Agents for lowering the blood pressure ⤷  Sign Up
Brazil 9506828 ⤷  Sign Up
Japan H0637487 ⤷  Sign Up
Australia 3074289 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYSTOLIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 SPC/GB96/048 United Kingdom ⤷  Sign Up PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
0334429 97C0002 Belgium ⤷  Sign Up PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0334429 C950031 Netherlands ⤷  Sign Up PRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018
>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.