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Last Updated: January 7, 2025

COGENTIN Drug Patent Profile


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Which patents cover Cogentin, and when can generic versions of Cogentin launch?

Cogentin is a drug marketed by Epic Pharma Llc and Merck and is included in two NDAs.

The generic ingredient in COGENTIN is benztropine mesylate. There are seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cogentin

A generic version of COGENTIN was approved as benztropine mesylate by PLIVA on August 10th, 1988.

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Summary for COGENTIN
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 58
Clinical Trials: 5
Patent Applications: 1,316
Drug Prices: Drug price information for COGENTIN
What excipients (inactive ingredients) are in COGENTIN?COGENTIN excipients list
DailyMed Link:COGENTIN at DailyMed
Drug patent expirations by year for COGENTIN
Drug Prices for COGENTIN

See drug prices for COGENTIN

Recent Clinical Trials for COGENTIN

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

SponsorPhase
Tanta UniversityPhase 2/Phase 3
University of California, San DiegoPhase 2
National Institute of Mental Health (NIMH)Phase 4

See all COGENTIN clinical trials

US Patents and Regulatory Information for COGENTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc COGENTIN benztropine mesylate INJECTABLE;INJECTION 012015-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck COGENTIN benztropine mesylate TABLET;ORAL 009193-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck COGENTIN benztropine mesylate TABLET;ORAL 009193-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck COGENTIN benztropine mesylate TABLET;ORAL 009193-003 Approved Prior to Jan 1, 1982 DISCN Yes 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

COGENTIN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Benztropine Mesylate (COGENTIN)

Introduction to Benztropine Mesylate (COGENTIN)

Benztropine mesylate, marketed under the brand name Cogentin, is an anticholinergic medication used to treat symptoms of Parkinson's disease and involuntary movements caused by certain psychiatric drugs. It works by blocking the neurotransmitter acetylcholine, thereby reducing muscle stiffness, sweating, and saliva production, and improving walking ability in patients with Parkinson's disease[1][4].

Market Dynamics

Drivers of the Market

The benztropine mesylate market is driven by several key factors:

  • Aging Population: The global increase in the aging population is associated with a higher prevalence of Parkinson's disease, which in turn drives the demand for benztropine mesylate[1].
  • Government Funding: Increased government funding for research and development in the healthcare sector, particularly for neurological disorders, supports the growth of this market[1].
  • Clinical Need: The ongoing need for effective treatments for Parkinson's disease and extrapyramidal symptoms ensures a steady demand for benztropine mesylate.

Restraints on the Market

Despite the positive drivers, there are several restraints that impact the market:

  • Alternative Treatments: The availability of alternative treatments and newer medications can reduce the market share of benztropine mesylate[1].
  • Stringent Regulations: Strict regulatory requirements and the need for continuous compliance can create barriers to market growth[1].

Market Segmentation

Route of Administration

The benztropine mesylate market is segmented based on the route of administration:

  • Oral: This is the most common route, with tablets or capsules being the preferred form.
  • Injection: Benztropine mesylate can also be administered intramuscularly or intravenously, particularly in acute situations[1][4].

Application

The market is also segmented based on application:

  • Parkinsonism: Benztropine mesylate is primarily used to treat symptoms of Parkinson's disease.
  • Extrapyramidal Symptoms: It is used to manage involuntary movements caused by antipsychotic medications[1].

Regional Framework

The benztropine mesylate market is analyzed across five major regions:

  • North America: This region is a significant market due to the high prevalence of Parkinson's disease and well-established healthcare infrastructure.
  • Europe: Countries in Europe also have a high incidence of Parkinson's disease, contributing to the market size.
  • Asia-Pacific (APAC): The APAC region is expected to grow rapidly due to an increasing aging population and improving healthcare facilities.
  • Middle East and Africa (MEA): This region presents opportunities for growth, though it is currently smaller compared to other regions.
  • South & Central America: This region also shows potential for market expansion, driven by increasing healthcare spending and awareness[1].

Market Players and Strategies

The benztropine mesylate market includes several key players:

  • Akorn
  • Zydus Pharmaceuticals
  • ANI Pharmaceuticals
  • PLIVA
  • Fresenius Kabi
  • Hikma Pharmaceuticals
  • Cipla
  • Navinta
  • Aspen Pharmacare
  • Hospira Inc.
  • LGM Pharma
  • SG Pharma

These companies employ various strategies to maintain and expand their market presence, including:

  • Organic Growth: Launches of new applications and end-user approvals, as well as patent filings and events.
  • Inorganic Growth: Acquisitions, partnerships, and collaborations to expand business and customer base[1].

Financial Trajectory

Market Size and Growth

The benztropine mesylate market is expected to witness significant growth during the forecast period from 2024 to 2031. The market size is projected to increase from its current value, driven by the factors mentioned above.

  • Historical Data: The market has shown steady growth from 2021 to 2022.
  • Forecast: The global CAGR for the benztropine mesylate market is expected to be substantial, indicating a robust growth trajectory[1].

Revenue Forecast

The revenue forecast for the benztropine mesylate market includes detailed analysis by region and segment. The report provides historical data from 2021 to 2022 and forecasts from 2024 to 2031, helping stakeholders understand the market's financial trajectory.

Cost and Pricing

The cost of benztropine mesylate can vary significantly depending on the region and the specific formulation. However, it is generally more affordable compared to some of the newer, more expensive treatments for Parkinson's disease.

  • Global Spending: While not as high as some other medications, the global spending on benztropine mesylate contributes to the overall healthcare expenditure. For instance, global spending on prescription drugs has topped $1.3 trillion, with a significant portion attributed to neurological treatments[3].

Financial Implications for Patients

The financial burden of long-term medications, including benztropine mesylate, can be substantial for patients. This includes higher health insurance premiums and direct out-of-pocket expenses such as co-pays and co-insurance.

  • Financial Toxicity: The cost of long-term medications can lead to financial toxicity, characterized by medical debt, income loss, and psychological stress. Patient access programs and cost-management strategies are crucial to mitigate these effects[3].

Competitive Landscape

The competitive landscape of the benztropine mesylate market is characterized by the presence of several key players. These companies compete based on factors such as product quality, pricing, and market reach.

  • SWOT Analysis: The report includes SWOT analyses of the leading players, providing insights into their strengths, weaknesses, opportunities, and threats. This helps in understanding their market strategies and competitive positioning[1].

PEST Analysis

A comprehensive PEST analysis (Political, Economic, Social, and Technological) is conducted for all five major regions. This analysis helps in understanding the external factors that affect the benztropine mesylate market.

  • Political Factors: Government policies and regulations play a crucial role in shaping the market.
  • Economic Factors: Economic conditions, including healthcare spending and reimbursement policies, impact market growth.
  • Social Factors: Demographic changes, such as the aging population, influence the demand for benztropine mesylate.
  • Technological Factors: Advances in medical technology and drug development can affect the market dynamics[1].

Key Takeaways

  • The benztropine mesylate market is driven by the growing aging population and the increasing prevalence of Parkinson's disease.
  • Government funding for research and stringent regulations are significant factors influencing market growth.
  • The market is segmented by route of administration (oral, injection) and application (parkinsonism, extrapyramidal symptoms).
  • Key players employ organic and inorganic growth strategies to maintain market presence.
  • The financial trajectory of the market is positive, with a significant CAGR expected during the forecast period.
  • Patient access programs and cost-management strategies are essential to mitigate the financial burden of long-term medications.

FAQs

What is benztropine mesylate used for?

Benztropine mesylate is used to treat symptoms of Parkinson's disease and involuntary movements caused by certain psychiatric drugs.

Which companies are key players in the benztropine mesylate market?

Key players include Akorn, Zydus Pharmaceuticals, ANI Pharmaceuticals, PLIVA, Fresenius Kabi, and others.

What are the main drivers of the benztropine mesylate market?

The main drivers include the growth in the aging population, the associated increase in the prevalence of Parkinson's disease, and government funding for research.

How is the benztropine mesylate market segmented?

The market is segmented by route of administration (oral, injection) and application (parkinsonism, extrapyramidal symptoms).

What are the financial implications for patients using benztropine mesylate?

Patients may face higher health insurance premiums and direct out-of-pocket expenses, contributing to financial toxicity if not managed properly.

What is the expected growth rate of the benztropine mesylate market?

The market is expected to witness significant growth, with a substantial CAGR during the forecast period from 2024 to 2031.

Sources

  1. The Insight Partners, Benztropine Mesylate Market SWOT Analysis by 2031, https://www.theinsightpartners.com/reports/benztropine-mesylate-market
  2. Escalent, Cogent Syndicated - Financial Services, https://escalent.co/industries/financial-services/cogent-syndicated-reports/
  3. Oxford University Press, Financial challenges of being on long-term, high-cost medications, https://academic.oup.com/nop/advance-article/doi/10.1093/nop/npae098/7915953?searchresult=1
  4. Wikipedia, Benzatropine, https://en.wikipedia.org/wiki/Benzatropine

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