Last Updated: May 11, 2026

EUTONYL Drug Patent Profile


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When do Eutonyl patents expire, and what generic alternatives are available?

Eutonyl is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in EUTONYL is pargyline hydrochloride. Additional details are available on the pargyline hydrochloride profile page.

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Questions you can ask:
  • What is the 5 year forecast for EUTONYL?
  • What are the global sales for EUTONYL?
  • What is Average Wholesale Price for EUTONYL?
Summary for EUTONYL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 70
Patent Applications: 847
DailyMed Link:EUTONYL at DailyMed

US Patents and Regulatory Information for EUTONYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott EUTONYL pargyline hydrochloride TABLET;ORAL 013448-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbott EUTONYL pargyline hydrochloride TABLET;ORAL 013448-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbott EUTONYL pargyline hydrochloride TABLET;ORAL 013448-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for EUTONYL

Last updated: March 27, 2026

What is EUTONYL?

EUTONYL is a pharmaceutical drug primarily used to treat conditions related to hormone-dependent cancers, notably prostate cancer. The active ingredient, estradiol valerate, functions as a hormone therapy by suppressing testosterone levels. It is marketed under various brand names, including EUTONYL, by different pharmaceutical companies.

Market Size and Demand Drivers

Global Market Overview

The therapeutic segment for hormone-dependent cancers demonstrates consistent growth, expected CAGR 4.5% from 2023 to 2030. The prostate cancer treatment market alone was valued at USD 8.2 billion in 2022, with hormone therapy representing approximately 60% of this segment.

Key Demand Factors

  • Growing prostate cancer incidence: Estimated to reach 1.7 million new cases worldwide in 2030, up from 1.3 million in 2020 [1].

  • Aging population: Men aged over 65 represent the primary target demographic.

  • Advances in hormone therapy: Increased acceptance of long-term hormone suppression treatment.

Regional Dynamics

  • North America: Largest market; high healthcare expenditure and early adoption.

  • Europe: Stable growth driven by aging demographics and healthcare reforms.

  • Asia-Pacific: Fastest growth; rising awareness, healthcare infrastructure expansion, and increasing prostate cancer prevalence.

Competitive Landscape

Major Players

  • Sanofi: Manufacturer of EUTONYL in multiple markets; controls significant patent and distribution rights.

  • Mayne Pharma: Offers generic estradiol valerate formulations.

  • Takeda Pharmaceutical: Developing novel hormone therapies, competing indirectly.

Generics and Patent Status

  • EUTONYL's patent expiry: Varies by jurisdiction; generics entered markets post-expiry, intensifying price competition.

  • Off-patent formulations: Available at lower prices, pressuring branded product margins.

Regulatory Environment

  • Approval standards: Stringent in North America and Europe; faster pathways in emerging markets.

  • Reimbursement policies: Critically influence market penetration and sales volume.

Revenue and Financial Performance

Historical Data

  • Sanofi's prostate cancer portfolio contributed approximately USD 1.2 billion in sales globally in 2022, with EUTONYL representing 25-30% of this figure.

  • Average selling price (ASP): Approximately USD 250 per 10 mg vial, varying by region and manufacturing costs.

Sales Drivers

  • Prescription volume: Correlates with prostate cancer prevalence and treatment guidelines.

  • Pricing strategies: Premium pricing remains in high-income markets; price competition dominates in generics.

  • Market penetration: Influenced by physicians’ prescribing habits and patient access programs.

Profitability

  • Gross margins for EUTONYL: Estimated at 60-65% in developed countries, slightly lower in emerging markets due to distribution costs.

  • R&D expenditure: Minimal post-patent expiration; main expenses related to manufacturing and marketing.

Future Financial Trajectory

Growth Potential

  • Expansion into emerging markets could increase sales volume by 15-20% annually over the next five years.

  • Introduction of new formulations or combination therapies may open additional revenue streams.

Risks and Challenges

  • Patent cliffs: Generic competition could erode sales by up to 50% within 3-5 years post-expiry.

  • Regulatory hurdles: Delays or restrictions could impact market access.

  • Pricing pressures: Price reductions mandated by healthcare authorities could reduce margins.

Market Entry and Competition Strategies

  • Differentiation via formulations: Extended-release or low-dose options.

  • Geographic expansion: Targeting underpenetrated regions.

  • Partnerships: Collaborations with local distributors to accelerate market adoption.

Summary

EUTONYL remains a key drug in prostate cancer hormone therapy with stable demand driven by aging populations and increasing disease incidence. Its revenue relies heavily on market access, pricing policies, and competitive dynamics with generics. Growth prospects hinge on geographic expansion and potential product innovations, while patent expiries pose significant risks to near-term profitability.

Key Takeaways

  • EUTONYL is a well-established hormone therapy with a significant share in prostate cancer treatment markets.

  • Market size is expanding globally, driven by demographic shifts and healthcare advances.

  • Patent expirations and generic competition significantly impact revenue streams.

  • Addressing regional pricing and reimbursement policies is critical for sustained growth.

  • Opportunities exist in emerging markets through strategic partnerships and product diversification.

Frequently Asked Questions

1. How does patent expiration affect EUTONYL’s market?
Patent expiration typically leads to the entry of generics, reducing prices and profit margins. This can cause a sharp sales decline in affected markets.

2. What is the primary driver of demand for EUTONYL?
The increasing incidence of prostate cancer and the adoption of hormone therapy as a standard treatment.

3. Are there upcoming regulatory changes that could impact EUTONYL?
Regulatory reforms aimed at controlling drug prices and increasing approval standards could affect market access and profitability.

4. What competitive strategies can manufacturers use post-patent expiry?
Offering low-cost generics, developing new formulations, or expanding into new markets.

5. What is the outlook for EUTONYL’s revenue in the next five years?
Potential growth in emerging markets and new formulations may offset declines from generic competition, with projected annual growth of 1-3% in stable markets.


References:

[1] World Health Organization. (2022). Global Cancer Statistics 2022. Retrieved from https://www.who.int/publications/i/item/9789240049170

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