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Last Updated: December 22, 2024

DARIFENACIN Drug Patent Profile


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

Darifenacin is a drug marketed by Macleods Pharms Ltd, Alembic, Aurobindo Pharma, Cipla, Endo Operations, Jubilant Generics, Polygen Pharms, Torrent, and Xiromed. and is included in nine NDAs.

The generic ingredient in DARIFENACIN is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Darifenacin

A generic version of DARIFENACIN was approved as darifenacin hydrobromide by CIPLA on September 1st, 2016.

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

See drug prices for DARIFENACIN

Recent Clinical Trials for DARIFENACIN

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

SponsorPhase
Universidad de ValparaisoPhase 3
Recalcine (GynoPharm)Phase 3
Center for Clinical Pharmacology Research Bdbeq S.A.Phase 1

See all DARIFENACIN clinical trials

Pharmacology for DARIFENACIN

US Patents and Regulatory Information for DARIFENACIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd DARIFENACIN darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207302-001 Jul 28, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 209571-001 Oct 22, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cipla DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207664-001 Sep 1, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alembic DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207681-002 Dec 8, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Jubilant Generics DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 205550-002 Oct 12, 2016 DISCN 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

EU/EMA Drug Approvals for DARIFENACIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
pharmaand GmbH Emselex darifenacin hydrobromide EMEA/H/C/000554
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Authorised no no no 2004-10-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

DARIFENACIN Market Analysis and Financial Projection Experimental

Darifenacin Hydrobromide Market Dynamics and Financial Trajectory

Overview of Darifenacin Hydrobromide

Darifenacin hydrobromide, marketed under the brand name Enablex, is a medication used to treat symptoms of an overactive bladder, such as incontinence and frequent urination. It works by relaxing the muscles of the bladder to prevent incontinence[5].

Market Growth and Forecast

The global darifenacin hydrobromide market is projected to experience significant growth over the coming years. Here are some key forecasts and trends:

  • CAGR and Market Size: The market is expected to grow with a Compound Annual Growth Rate (CAGR) of 6.1% from 2024 to 2030. This growth is driven by the increasing prevalence of overactive bladder, particularly among the aging population[3].
  • Regional Growth: North America is anticipated to witness the highest growth, followed by other regions such as Europe, Asia Pacific, and the Rest of the World. The U.S. market, in particular, has seen increased patient awareness and education initiatives, leading to higher prescription rates[1][3].

Key Drivers of the Market

Several factors are driving the growth of the darifenacin hydrobromide market:

Increasing Prevalence of Urinary Disorders

The growing incidence of urinary disorders, especially among the elderly, is a significant driver. Awareness campaigns promoting early diagnosis and treatment further contribute to this trend, leading to increased prescription rates[1][3].

Advancements in Pharmaceutical Technology

Innovations in drug formulation and delivery systems, such as extended-release options, are enhancing patient adherence and reducing side effects. These advancements attract both healthcare providers and patients seeking effective and convenient treatment solutions[1][3].

Supportive Regulatory Environment

Favorable regulatory policies and expedited approval processes for new drugs, including generics, are facilitating market growth. Governments are recognizing the need for effective treatments for urinary disorders, leading to streamlined approval pathways[1][3].

Rising Healthcare Expenditure

Increasing healthcare expenditure, particularly in developing countries, is improving access to medications. Higher healthcare spending allows for broader coverage of treatments for overactive bladder, increasing prescription rates[1][3].

Emerging Trends

E-Pharmacy Platforms

The proliferation of e-pharmacy platforms is providing a unique opportunity for darifenacin hydrobromide’s market penetration. Patients prefer online purchasing for convenience and privacy, which enhances access to medications and enables better patient education and treatment adherence[1].

Telehealth and Geriatric Care

Telehealth services are facilitating better patient monitoring and adherence to treatment, especially in geriatric care. This trend is particularly significant in regions like Germany, where increased funding for research and development has led to innovative delivery systems[1][3].

Combination Therapies

Advances in combination therapies are enhancing treatment efficacy and patient outcomes. This includes the development of new formulations and the integration of darifenacin hydrobromide with other treatments to manage overactive bladder more effectively[3].

Challenges and Considerations

Anticholinergic Side Effects

There is a growing concern about the long-term use of anticholinergic drugs, including darifenacin hydrobromide, due to their association with an increased risk of dementia. Studies have shown that prolonged exposure to these drugs can significantly increase the risk of dementia, which may impact long-term prescription rates[2].

Regulatory Hurdles

While the regulatory environment is generally supportive, there are still challenges related to the approval and monitoring of new drugs. Ensuring compliance with regulatory standards can be complex and may slow down market entry for new formulations[1][3].

Intense Competition

The market for overactive bladder treatments is highly competitive, with various drugs and therapies available. Pharmaceutical companies must invest in marketing strategies and R&D to maintain market share and drive growth[1][3].

Regional Market Analysis

United States

The U.S. market has benefited from increased patient awareness and education initiatives. Recent studies highlighting the drug's effectiveness have led to a rise in prescriptions. The FDA's expedited approval processes for generic versions have also enhanced accessibility and affordability[1].

China

The Chinese market has expanded significantly due to the growing elderly population and rising prevalence of urinary disorders. Local manufacturers are producing affordable generics, and clinical trials are ongoing to evaluate the drug’s effectiveness across diverse populations[1].

Germany

In Germany, advancements in pharmaceutical technology have led to improved formulations that enhance patient compliance. Increased funding for R&D and the rise of telemedicine have facilitated better patient monitoring and adherence to treatment[1].

India

The Indian market is experiencing robust growth due to an increase in lifestyle-related urinary disorders. Government initiatives aimed at improving healthcare access and affordability have resulted in an uptick in prescriptions. The rise of e-pharmacy platforms is also facilitating easier access to medication[1].

Financial Trajectory

Market Size Estimates

The darifenacin hydrobromide market size is estimated in terms of value, with projections indicating significant growth from 2024 to 2030. The market is valued in billions of dollars, reflecting the increasing demand for effective overactive bladder treatments[3].

Revenue Streams

Revenue is expected to come from various segments, including hospital and clinic markets. The 7.5mg dosage is anticipated to witness higher growth, and clinic applications are expected to drive significant revenue[1][3].

Investment Opportunities

Strategic opportunities exist across various applications, driven by demographic shifts, evolving healthcare policies, and advances in drug formulation. Stakeholders can capitalize on growth potential by focusing on applications like geriatric care, telehealth, combination therapies, awareness campaigns, and e-pharmacy platforms[3].

Key Takeaways

  • The darifenacin hydrobromide market is poised for significant growth driven by the increasing prevalence of urinary disorders and advancements in pharmaceutical technology.
  • Emerging trends such as e-pharmacy platforms, telehealth, and combination therapies are reshaping the market landscape.
  • Regulatory support and rising healthcare expenditure are key drivers, but challenges such as anticholinergic side effects and intense competition must be navigated.
  • Regional markets, particularly in the U.S., China, Germany, and India, are experiencing robust growth due to various factors including government initiatives and technological advancements.

FAQs

Q: What is darifenacin hydrobromide used for?

Darifenacin hydrobromide is used to treat symptoms of an overactive bladder, such as incontinence and frequent urination[5].

Q: What are the key drivers of the darifenacin hydrobromide market?

Key drivers include the increasing prevalence of urinary disorders, advancements in pharmaceutical technology, a supportive regulatory environment, and rising healthcare expenditure[1][3].

Q: What are the potential side effects of darifenacin hydrobromide?

Potential side effects include bladder pain, bloody or cloudy urine, difficult or painful urination, and dizziness. Long-term use is also associated with an increased risk of dementia[2][5].

Q: How is the darifenacin hydrobromide market expected to grow in the future?

The market is expected to grow with a CAGR of 6.1% from 2024 to 2030, driven by emerging trends and increasing demand for effective overactive bladder treatments[3].

Q: What are the strategic growth opportunities in the darifenacin hydrobromide market?

Strategic opportunities include focusing on geriatric care, telehealth, combination therapies, awareness campaigns, and e-pharmacy platforms to drive demand and enhance treatment outcomes[3].

Sources

  1. Research and Markets: Darifenacin Hydrobromide Market Report: Trends, Forecast and Competitive Analysis.
  2. JAMA Network: Anticholinergic Drug Exposure and the Risk of Dementia.
  3. Lucintel: Darifenacin Hydrobromide Market Report: Trends, Forecast and Competitive Analysis.
  4. Market Research Reports: Global Darifenacin Hydrobromide Market Research Report 2024.
  5. Mayo Clinic: Darifenacin (oral route) - Mayo Clinic.

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