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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Teva
McKesson
Farmers Insurance
Chinese Patent Office
Covington
Express Scripts
Novartis
Fish and Richardson
US Department of Justice

Generated: January 18, 2018

DrugPatentWatch Database Preview

Nebivolol hydrochloride - Generic Drug Details

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What are the generic drug sources for nebivolol hydrochloride and what is the scope of nebivolol hydrochloride freedom to operate?

Nebivolol hydrochloride
is the generic ingredient in three branded drugs marketed by Forest Labs, Alkem Labs Ltd, Amerigen Pharms Ltd, Glenmark Pharms Ltd, Indchemie Health, Watson Labs Inc, and Forest Labs Llc, and is included in seven NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nebivolol hydrochloride has twenty-seven patent family members in twenty-two countries.

There are fourteen drug master file entries for nebivolol hydrochloride. Seven suppliers are listed for this compound.
Summary for nebivolol hydrochloride
International Patents:27
US Patents:3
Tradenames:3
Applicants:7
NDAs:7
Drug Master File Entries: 14
Suppliers / Packagers: 7
Bulk Api Vendors: 83
Clinical Trials: 75
Drug Prices:see low prices
DailyMed Link:nebivolol hydrochloride at DailyMed
Pharmacology for nebivolol hydrochloride
Medical Subject Heading (MeSH) Categories for nebivolol hydrochloride

US Patents and Regulatory Information for nebivolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs Inc NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203683-004 Nov 27, 2015 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Llc BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302-001 Jun 3, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glenmark Pharms Ltd NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203821-001 May 25, 2017 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Indchemie Health NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203828-003 Jul 29, 2015 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glenmark Pharms Ltd NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203821-002 May 25, 2017 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-004 Dec 17, 2007 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Indchemie Health NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203828-002 Jul 29, 2015 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Indchemie Health NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203828-004 Jul 29, 2015 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Indchemie Health NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203828-001 Jul 29, 2015 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for nebivolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-002 Dec 17, 2007 ➤ Subscribe ➤ Subscribe
Forest Labs BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007 ➤ Subscribe ➤ Subscribe
Forest Labs BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-005 Oct 8, 2008 ➤ Subscribe ➤ Subscribe
Forest Labs BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-004 Dec 17, 2007 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for nebivolol hydrochloride

Supplementary Protection Certificates for nebivolol hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0002 Belgium ➤ Subscribe PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
C/GB96/048 United Kingdom ➤ Subscribe PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
50031 Netherlands ➤ Subscribe PRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
Medtronic
Julphar
Novartis
Colorcon
McKesson
Cipla
Express Scripts

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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