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Last Updated: September 27, 2021

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Nebivolol hydrochloride - Generic Drug Details

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

Nebivolol hydrochloride is the generic ingredient in three branded drugs marketed by Allergan, Alkem Labs Ltd, Ani Pharms, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Torrent, and Watson Labs Inc, and is included in nine 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. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for nebivolol hydrochloride
Recent Clinical Trials for nebivolol hydrochloride

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

SponsorPhase
Daewoong Pharmaceutical Co. LTD.Phase 1
Betaliq, Inc.Phase 2
Summit Analytical, LLCPhase 2

See all nebivolol hydrochloride clinical trials

Generic filers with tentative approvals for NEBIVOLOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free2.5MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free20MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nebivolol hydrochloride
Medical Subject Heading (MeSH) Categories for nebivolol hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for nebivolol hydrochloride
Paragraph IV (Patent) Challenges for NEBIVOLOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BYSTOLIC TABLET;ORAL nebivolol hydrochloride 021742 2011-12-19

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
Indchemie Health NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203828-002 Jul 29, 2015 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Torrent NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203966-001 Mar 2, 2018 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Torrent NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203966-004 Mar 2, 2018 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Indchemie Health NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203828-004 Jul 29, 2015 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Glenmark Pharms Ltd NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203821-003 May 25, 2017 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 nebivolol hydrochloride

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

Supplementary Protection Certificates for nebivolol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0334429 C950031 Netherlands ⤷  Try it Free PRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018
0334429 SPC/GB96/048 United Kingdom ⤷  Try it Free 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 ⤷  Try it Free PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Baxter
Boehringer Ingelheim
Dow
AstraZeneca
Colorcon

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