Nebivolol hydrochloride - Generic Drug Details

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 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-four 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:	24
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
		20MG	TABLET;ORAL
		10MG	TABLET;ORAL
		5MG	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	203659-003	Apr 16, 2015	AB	RX	No	No
Abbvie	BYVALSON	nebivolol hydrochloride; valsartan	TABLET;ORAL	206302-001	Jun 3, 2016		DISCN	Yes	No
Unichem	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	213830-003	Mar 15, 2022	AB	RX	No	No

Expired US Patents for nebivolol hydrochloride

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

Nebivolol hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nebivolol Hydrochloride

Market Overview

The nebivolol hydrochloride market has been experiencing significant growth in recent years, and this trend is expected to continue through the forecast period of 2023 to 2031. Here are the key points that outline the market dynamics and financial trajectory of nebivolol hydrochloride.

Market Size and Growth Projections

The nebivolol hydrochloride market has seen a swift and substantial rise, with forecasts indicating sustained significant expansion. The market size is projected to grow at a robust rate, driven by increasing demand for effective treatments for essential hypertension and chronic heart failure[1][4].

Segmentation

The market is segmented based on type (20mg, 50mg, 100mg, and others) and application (treatment of essential hypertension, treatment of chronic heart failure, and others). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation helps in understanding the specific drivers and challenges in different regions and application areas[1].

Drivers of Growth

Several factors are driving the growth of the nebivolol hydrochloride market:

• Increasing Prevalence of Hypertension and Heart Failure: The rising incidence of cardiovascular diseases globally is a significant driver. Nebivolol hydrochloride's effectiveness in treating these conditions makes it a preferred choice among healthcare providers[1][5].
• Cost-Effectiveness: Studies have shown that nebivolol is a cost-effective treatment for elderly patients with heart failure compared to standard care, which adds to its market appeal[3].
• Pharmacological Advantages: Nebivolol hydrochloride acts as a β1-adrenergic receptor antagonist, providing unique therapeutic benefits that differentiate it from other beta-blockers[5].

Market Constraints and Challenges

Despite the positive growth trajectory, there are several challenges that the market faces:

• Regulatory Hurdles: Ensuring compliance with regulatory standards, such as stability studies and bioequivalence tests, can be time-consuming and costly. For instance, the stability studies for nebivolol hydrochloride must be conducted under ICH conditions to justify the re-test period[2].
• Market Competition: The presence of other beta-blockers and cardiovascular drugs in the market can pose a challenge to the growth of nebivolol hydrochloride. However, its unique pharmacological profile helps it maintain a competitive edge[5].

Key Players and Market Competition

The nebivolol hydrochloride market is characterized by the presence of several key players, including Tocris Bioscience, Cayman Chemical, Meck, Targetmol, and others. These companies are involved in the production and distribution of nebivolol hydrochloride across various regions. The market competition is driven by factors such as product pricing, product penetration, and the quality of the drug substance and finished product[1].

Financial Trajectory

Revenue Projections

The market is expected to generate significant revenue, measured in USD million, across the forecast period. The revenue growth is anticipated to be robust, driven by the increasing demand for nebivolol hydrochloride in treating cardiovascular diseases[1].

Cost-Effectiveness Analysis

Studies have shown that nebivolol is cost-effective, particularly in the treatment of heart failure in elderly patients. For example, a cost-effectiveness analysis from the UK NHS perspective indicated that nebivolol provided better quality-adjusted life years (QALYs) at a lower incremental cost compared to standard care[3].

Economic Impact

The economic impact of nebivolol hydrochloride extends beyond direct drug costs. It includes costs associated with GP visits, outpatient specialist visits, and cardiovascular-related hospitalizations. The overall economic analysis suggests that nebivolol hydrochloride can reduce healthcare costs in the long term by reducing the need for frequent hospitalizations and other medical interventions[3].

Geographical Analysis

The market for nebivolol hydrochloride varies geographically, with different regions exhibiting different growth rates and market dynamics.

• North America and Europe: These regions are expected to remain significant markets due to the high prevalence of cardiovascular diseases and well-established healthcare systems.
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a growing awareness of cardiovascular health[1].

Future Outlook

The future outlook for the nebivolol hydrochloride market is positive, driven by the ongoing need for effective treatments for cardiovascular diseases. Here are some key points:

• Sustained Growth: The market is expected to continue its upward trend, driven by increasing demand and the cost-effectiveness of nebivolol hydrochloride.
• New Indications: Research into new indications, such as pulmonary disease and peripheral arterial disease, could further expand the market for nebivolol hydrochloride[5].

Key Takeaways

• Robust Market Growth: The nebivolol hydrochloride market is expected to grow significantly from 2023 to 2031.
• Cost-Effectiveness: Nebivolol hydrochloride is a cost-effective treatment for cardiovascular diseases, particularly in elderly patients.
• Geographical Variations: The market dynamics vary across different regions, with North America, Europe, and Asia-Pacific being key markets.
• Regulatory Compliance: Ensuring regulatory compliance is crucial for market success.
• Competitive Landscape: The market is competitive, with several key players involved in the production and distribution of nebivolol hydrochloride.

FAQs

Q: What are the primary applications of nebivolol hydrochloride?

A: The primary applications of nebivolol hydrochloride include the treatment of essential hypertension and chronic heart failure.

Q: What is the expected growth rate of the nebivolol hydrochloride market?

A: The market is expected to grow at a robust rate from 2023 to 2031, driven by increasing demand and cost-effectiveness.

Q: Who are the key players in the nebivolol hydrochloride market?

A: Key players include Tocris Bioscience, Cayman Chemical, Meck, Targetmol, and others.

Q: Is nebivolol hydrochloride cost-effective?

A: Yes, nebivolol hydrochloride has been shown to be cost-effective, particularly in the treatment of heart failure in elderly patients.

Q: What are the geographical regions driving the growth of the nebivolol hydrochloride market?

A: North America, Europe, and Asia-Pacific are the key geographical regions driving the market growth.

Sources

1. Market Research Intellect: Nebivolol Hydrochloride Market Size, Scope And Forecast Report.
2. Public Assessment Report: Scientific discussion Nebivolol ARX 5 mg.
3. PubMed: Long-term cost-effectiveness analysis of nebivolol compared with standard care.
4. News Channel Nebraska: Nebivolol Hydrochloride Market Dynamics till 2032.
5. Synapse: Nebivolol hydrochloride - Drug Targets, Indications, Patents.