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Last Updated: November 27, 2022

Nebivolol hydrochloride - Generic Drug Details


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What are the generic drug sources for nebivolol hydrochloride and what is the scope of patent protection?

Nebivolol hydrochloride is the generic ingredient in four branded drugs marketed by Allergan, Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Prinston Inc, Reyoung, Torrent, Unichem, and Watson Labs Inc, and is included in sixteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for nebivolol hydrochloride. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for nebivolol hydrochloride

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

SponsorPhase
Clinical Hospital Center ZemunPhase 4
Daewoong Pharmaceutical Co. LTD.Phase 1
Menarini International Operations Luxembourg SAPhase 4

See all nebivolol hydrochloride clinical trials

Generic filers with tentative approvals for NEBIVOLOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing20MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing5MGTABLET;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
Paragraph IV (Patent) Challenges for NEBIVOLOL HYDROCHLORIDE
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 nebivolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203821-003 May 25, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ajanta Pharma Ltd NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 213349-003 Mar 31, 2022 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Indchemie Health NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203828-003 Jul 29, 2015 AB RX No No See Plans and Pricing See Plans and Pricing 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

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 See Plans and Pricing See Plans and Pricing
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007 See Plans and Pricing See Plans and Pricing
Allergan BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-004 Dec 17, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Johnson and Johnson
Merck
Medtronic
Moodys

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.