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Last Updated: December 21, 2024

NORLIQVA Drug Patent Profile


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Which patents cover Norliqva, and what generic alternatives are available?

Norliqva is a drug marketed by Cmp Dev Llc and is included in one NDA. There are four patents protecting this drug.

The generic ingredient in NORLIQVA is amlodipine besylate. There are fifty drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Norliqva

A generic version of NORLIQVA was approved as amlodipine besylate by COREPHARMA on May 23rd, 2007.

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Summary for NORLIQVA
Drug patent expirations by year for NORLIQVA
Drug Prices for NORLIQVA

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Pharmacology for NORLIQVA

US Patents and Regulatory Information for NORLIQVA

NORLIQVA is protected by eleven US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cmp Dev Llc NORLIQVA amlodipine besylate SOLUTION;ORAL 214439-001 Feb 24, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Cmp Dev Llc NORLIQVA amlodipine besylate SOLUTION;ORAL 214439-001 Feb 24, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Cmp Dev Llc NORLIQVA amlodipine besylate SOLUTION;ORAL 214439-001 Feb 24, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NORLIQVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norliqva

Introduction to Norliqva

Norliqva, also known as amlodipine, is an oral solution approved by the FDA in February 2022 for the treatment of hypertension in adults and children 6 years and older. This medication is designed to lower blood pressure and manage coronary artery disease.

Market Context

The approval of Norliqva is set against the backdrop of a growing cardiovascular drugs market. Here are some key market dynamics that influence the trajectory of Norliqva:

Global Cardiovascular Drugs Market

The cardiovascular drugs market is projected to reach USD 155.27 billion in 2024 and grow at a CAGR of 3.30% to reach USD 182.63 billion by 2029. This growth is driven by the rising prevalence of cardiovascular diseases (CVDs) globally, increasing R&D investments, and the availability of reimbursement policies[1].

Regional Market Dominance

North America is expected to hold a significant share of the cardiovascular drugs market, driven by factors such as a sedentary lifestyle, lack of physical activity, and rising obesity rates. These factors contribute to an increase in hypertension and other cardiovascular conditions, thereby driving the demand for medications like Norliqva[1].

Product Approval and Innovation

Recent Approvals

The FDA approval of Norliqva in February 2022 is a significant milestone. Such approvals are anticipated to accelerate the growth of the cardiovascular drugs segment. Other recent approvals, such as Leqvio (inclisiran) for lowering LDL-C, also indicate a favorable regulatory environment that supports innovation in cardiovascular treatments[1].

Impact on Market Growth

The approval of Norliqva and similar drugs is expected to drive market growth through increased product availability and patient access. These approvals often lead to higher adoption rates among healthcare providers, contributing to the overall market expansion.

Financial Trajectory

Revenue Potential

Given the growing demand for cardiovascular medications, Norliqva is poised to contribute significantly to the revenue streams of its manufacturers. The global market for cardiovascular drugs is expanding, and new product approvals are key drivers of this growth.

Competitive Landscape

The market for cardiovascular drugs is highly competitive, with several established players. However, the approval of Norliqva provides a competitive edge due to its unique formulation as an oral solution, which can be particularly beneficial for patients who have difficulty swallowing tablets.

Regulatory and Economic Factors

Inflation Reduction Act (IRA) Impact

The Inflation Reduction Act (IRA) introduces new Medicare pricing rules that can affect the economic lifecycle of branded medications. This could lead to shorter timelines for product exclusivity and lower economic incentives, potentially impacting the long-term revenue projections for Norliqva. However, since Norliqva is a generic formulation of amlodipine, it may be less affected by these changes compared to new, innovative molecules[3].

Generic and Biosimilar Market Dynamics

The IRA's impact on the late lifecycle net price of branded products can also affect the economic incentives for launching generic or biosimilar versions. However, Norliqva, being a generic oral solution, is likely to benefit from the existing demand for amlodipine and the favorable regulatory environment in regions like North America[3].

Consumer and Healthcare Provider Adoption

Patient Needs and Preferences

The oral solution formulation of Norliqva addresses a specific patient need, particularly for those who have difficulty with traditional tablets. This can lead to higher patient compliance and satisfaction, driving adoption rates among healthcare providers.

Healthcare System Support

Advanced healthcare systems in regions like North America, equipped with modern medical technologies and favorable regulatory environments, support the diagnosis and treatment of cardiovascular conditions effectively. This infrastructure facilitates the prescription and use of medications like Norliqva[4].

Challenges and Opportunities

Market Competition

Despite the competitive landscape, Norliqva's unique formulation and FDA approval present opportunities for market penetration. Manufacturers must focus on marketing strategies and clinical trials to differentiate their product and demonstrate its efficacy.

Future Growth Strategies

To maintain growth, manufacturers of Norliqva should focus on expanding their geographical reach, enhancing operational efficiencies, and investing in research and development. This includes exploring new indications and formulations to stay competitive in the market[5].

Key Takeaways

  • Market Growth: The cardiovascular drugs market is expected to grow significantly, driven by rising CVD prevalence and favorable regulatory environments.
  • Product Approval: The FDA approval of Norliqva is a key driver for market growth and patient access.
  • Financial Trajectory: Norliqva is poised to contribute to revenue growth, especially in regions like North America.
  • Regulatory Impact: The IRA may affect the economic lifecycle of branded medications but has less impact on generic formulations like Norliqva.
  • Consumer Adoption: The oral solution formulation of Norliqva addresses specific patient needs, leading to higher adoption rates.

FAQs

  1. What is Norliqva, and what is it used for? Norliqva is an oral solution of amlodipine, approved by the FDA for treating hypertension in adults and children 6 years and older, as well as managing coronary artery disease.

  2. How does the FDA approval of Norliqva impact the market? The FDA approval of Norliqva is expected to drive market growth by increasing product availability and patient access, contributing to the overall expansion of the cardiovascular drugs segment.

  3. What are the key factors driving the growth of the cardiovascular drugs market? The growth is driven by the rising prevalence of CVDs globally, increasing R&D investments, and the availability of reimbursement policies.

  4. How does the Inflation Reduction Act (IRA) affect Norliqva? The IRA introduces new pricing rules that could affect the economic lifecycle of branded medications, but Norliqva, being a generic formulation, is likely to be less affected.

  5. What are the future growth strategies for Norliqva? Manufacturers should focus on expanding geographical reach, enhancing operational efficiencies, and investing in R&D to explore new indications and formulations.

References

[1] https://www.mordorintelligence.com/industry-reports/cardiovascular-drugs-market [3] https://www.iqvia.com/locations/united-states/blogs/2024/09/impact-of-the-inflation-reduction-act [4] https://www.transparencymarketresearch.com/calcium-channel-blockers-market.html [5] https://stockdiscovery.s3.amazonaws.com/india/company/3315/2279/AR-24.pdf

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