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Last Updated: December 22, 2024

ELDEPRYL Drug Patent Profile


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

Eldepryl is a drug marketed by Norvium Bioscience and is included in one NDA.

The generic ingredient in ELDEPRYL is selegiline hydrochloride. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.

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Recent Clinical Trials for ELDEPRYL

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SponsorPhase
Second Affiliated Hospital of Soochow UniversityPhase 4
University of South FloridaPhase 4

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US Patents and Regulatory Information for ELDEPRYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Norvium Bioscience ELDEPRYL selegiline hydrochloride CAPSULE;ORAL 020647-001 May 15, 1996 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

ELDEPRYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ELDEPRYL

Introduction

ELDEPRYL, also known as selegiline, is a medication primarily used in the treatment of Parkinson's disease. It belongs to the class of monoamine oxidase B (MAO-B) inhibitors, which help increase the levels of dopamine in the brain, thereby alleviating symptoms of Parkinson's disease. Here, we will delve into the market dynamics and financial trajectory of ELDEPRYL.

Market Overview

Parkinson's Disease Market

The global Parkinson's disease market is driven by the increasing prevalence of the disease, advancements in treatment options, and the growing demand for effective therapies. As the population ages, the incidence of Parkinson's disease is expected to rise, creating a larger market for treatments like ELDEPRYL[5].

Competitive Landscape

The Parkinson's disease treatment market is highly competitive, with various drugs and therapies available. ELDEPRYL competes with other MAO-B inhibitors, dopamine agonists, and combination therapies. The competitive landscape is further complicated by the development of new drugs and formulations, such as extended-release versions and fixed-dose combinations[3].

Clinical Significance and Usage

Efficacy and Safety

ELDEPRYL is known for its efficacy in managing Parkinson's disease symptoms, particularly when used as an adjunct to levodopa/carbidopa therapy. However, it also comes with a range of side effects, including nausea, hallucinations, confusion, and orthostatic hypotension. These side effects can impact patient compliance and market demand[1][4].

Patient Population

ELDEPRYL is primarily prescribed for patients with Parkinson's disease, particularly those in the earlier phases of the disease. The drug's effectiveness and safety profile vary across different patient demographics, with older patients being at a higher risk for certain side effects like hypertension and somnolence[1].

Regulatory Environment

FDA Approval and Guidelines

ELDEPRYL was approved by the FDA for the treatment of Parkinson's disease, and its use is subject to specific guidelines. The FDA warns against the concurrent use of ELDEPRYL with certain antidepressants due to the risk of severe CNS toxicity. This regulatory environment can influence prescribing practices and market dynamics[4].

Financial Performance

Revenue and Sales

The financial performance of ELDEPRYL is tied to its market share and the overall demand for Parkinson's disease treatments. While specific revenue figures for ELDEPRYL are not publicly disclosed, the drug's sales are influenced by factors such as prescription rates, competition from generic versions, and the introduction of new therapies.

Pricing and Reimbursement

The pricing of ELDEPRYL can vary based on geographical location, insurance coverage, and government reimbursement policies. In many markets, the drug is covered by health insurance plans, which can affect its financial trajectory. Changes in reimbursement policies or pricing strategies can significantly impact the drug's revenue[3].

Strategic Partnerships and Development

Collaborations and Licensing

Companies involved in the development and marketing of ELDEPRYL often engage in strategic partnerships to enhance their market position. For example, partnerships with other pharmaceutical companies can facilitate distribution, marketing, and the development of new formulations or combinations[3].

Research and Development

Continuous research and development are crucial for maintaining a competitive edge in the Parkinson's disease treatment market. Companies invest in clinical trials to explore new indications and improve existing treatments. For instance, the development of extended-release versions or fixed-dose combinations can expand the market for ELDEPRYL[3].

Market Trends and Future Outlook

Growing Demand for Personalized Medicine

There is an increasing trend towards personalized medicine, which could impact the market for ELDEPRYL. As genetic and biomarker testing become more prevalent, treatments may be tailored to individual patient profiles, potentially altering the demand for specific drugs[5].

Emerging Therapies

The emergence of new therapies, including gene therapies and stem cell treatments, could disrupt the market for traditional Parkinson's disease treatments like ELDEPRYL. However, these new therapies are still in the experimental stages, and ELDEPRYL is likely to remain a significant player in the near future[5].

Challenges and Opportunities

Side Effect Management

One of the significant challenges for ELDEPRYL is managing its side effects, which can lead to treatment discontinuation. Addressing these issues through dose adjustments or combination therapies presents an opportunity to improve patient outcomes and market performance[1].

Expanding Indications

Exploring new indications for ELDEPRYL, such as treating other CNS disorders, could expand its market potential. For example, if ELDEPRYL were approved for additional uses, it could attract a broader patient population and increase revenue[3].

Key Takeaways

  • Market Growth: The Parkinson's disease market is growing due to increasing prevalence and demand for effective treatments.
  • Competitive Landscape: ELDEPRYL faces competition from other MAO-B inhibitors and combination therapies.
  • Regulatory Environment: Strict guidelines govern the use of ELDEPRYL, particularly regarding concurrent use with antidepressants.
  • Financial Performance: Revenue is influenced by prescription rates, competition, and reimbursement policies.
  • Strategic Partnerships: Collaborations are essential for market expansion and new formulation development.
  • Future Outlook: Emerging therapies and personalized medicine trends may impact the market, but ELDEPRYL remains a significant player.

FAQs

What is ELDEPRYL used for?

ELDEPRYL (selegiline) is used as an adjunct in the treatment of Parkinson's disease to manage symptoms.

What are the common side effects of ELDEPRYL?

Common side effects include nausea, hallucinations, confusion, loss of balance, insomnia, and orthostatic hypotension.

Can ELDEPRYL be used with antidepressants?

No, ELDEPRYL should not be used concurrently with certain antidepressants due to the risk of severe CNS toxicity.

How does the FDA regulate ELDEPRYL?

The FDA has specific guidelines for the use of ELDEPRYL, including warnings against its use with certain antidepressants and recommendations for dose adjustments.

What is the future outlook for ELDEPRYL in the market?

While emerging therapies may impact the market, ELDEPRYL is likely to remain a significant player due to its established efficacy and ongoing research into new formulations and indications.

Sources

  1. Drugs.com: Eldepryl Side Effects: Common, Severe, Long Term.
  2. Annual Reports: Putting the Pieces in Place - Annual Reports.
  3. Accessdata.fda.gov: CAPSULES - accessdata.fda.gov.
  4. BioRxiv: Parkinson's Disease affects the contextual control, but not ... - bioRxiv.
  5. Effectivehealthcare.ahrq.gov: Attention Deficit Hyperactivity Disorder (ADHD).

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