NEBIVOLOL HYDROCHLORIDE - Generic Drug Details

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

Nebivolol hydrochloride is the generic ingredient in four branded drugs marketed by Allergan, Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Beximco Pharms Usa, Cadila Pharms Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Mankind Pharma, MSN, Prinston Inc, Reyoung, Torrent, Unichem, Watson Labs Inc, and Abbvie, and is included in twenty 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. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for NEBIVOLOL HYDROCHLORIDE

US Patents:	2
Tradenames:	4
Applicants:	19
NDAs:	20
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	95
Patent Applications:	137
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEBIVOLOL HYDROCHLORIDE
What excipients (inactive ingredients) are in NEBIVOLOL HYDROCHLORIDE?	NEBIVOLOL HYDROCHLORIDE excipients list
DailyMed Link:	NEBIVOLOL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NEBIVOLOL HYDROCHLORIDE

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

Sponsor	Phase
Clinical Hospital Center Zemun	Phase 4
Daewoong Pharmaceutical Co. LTD.	Phase 1
Menarini International Operations Luxembourg SA	Phase 4

See all NEBIVOLOL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for NEBIVOLOL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2.5MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	20MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	10MG	TABLET;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

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for NEBIVOLOL HYDROCHLORIDE

Adrenergic beta-1 Receptor Agonists
Antihypertensive Agents
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for NEBIVOLOL HYDROCHLORIDE

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs Inc	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	203683-004	Nov 27, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	203821-003	May 25, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Reyoung	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	212917-003	Dec 17, 2021	AB	RX	No	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 NEBIVOLOL HYDROCHLORIDE

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

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