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Last Updated: December 22, 2024

NEBIVOLOL HYDROCHLORIDE Drug Patent Profile


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When do Nebivolol Hydrochloride patents expire, and when can generic versions of Nebivolol Hydrochloride launch?

Nebivolol Hydrochloride is a drug marketed by 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, and Watson Labs Inc. and is included in seventeen NDAs.

The generic ingredient in NEBIVOLOL HYDROCHLORIDE is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nebivolol Hydrochloride

A generic version of NEBIVOLOL HYDROCHLORIDE was approved as nebivolol hydrochloride by ANI PHARMS on April 16th, 2015.

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Drug patent expirations by year for NEBIVOLOL HYDROCHLORIDE
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

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 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
Mankind Pharma NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 216172-003 Nov 14, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd Iii NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203825-002 Nov 3, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Prinston Inc NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 212682-003 Apr 7, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unichem NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 213830-002 Mar 15, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Msn NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 217397-003 Oct 1, 2024 AB RX 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

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.

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