You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 30, 2026

Endo Operations Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Endo Operations
International Patents:76
US Patents:7
Tradenames:23
Ingredients:19
NDAs:23
Patent Litigation for Endo Operations: See patent lawsuits for Endo Operations

Drugs and US Patents for Endo Operations

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations EDEX alprostadil INJECTABLE;INJECTION 020649-007 Jul 30, 1998 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Endo Operations NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Endo Operations EDEX alprostadil INJECTABLE;INJECTION 020649-002 Jun 12, 1997 AP RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-002 Jun 22, 2006 DISCN Yes No 8,808,737 ⤷  Get Started Free ⤷  Get Started Free
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-006 Feb 29, 2008 DISCN Yes No 8,808,737 ⤷  Get Started Free ⤷  Get Started Free
Endo Operations PERCOCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 040330-002 Jun 25, 1999 AA RX No Yes ⤷  Get Started Free ⤷  Get Started Free
Endo Operations PERCOCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 040330-001 Jun 25, 1999 AA RX No Yes ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Endo Operations

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Operations SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 6,135,979 ⤷  Get Started Free
Endo Operations TESTIM testosterone GEL;TRANSDERMAL 021454-001 Oct 31, 2002 7,935,690 ⤷  Get Started Free
Endo Operations FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463-001 Dec 29, 2010 6,579,865 ⤷  Get Started Free
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006 5,958,456 ⤷  Get Started Free
Endo Operations SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 8,241,243 ⤷  Get Started Free
Endo Operations SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 5,891,086 ⤷  Get Started Free
Endo Operations NASCOBAL cyanocobalamin SPRAY, METERED;NASAL 021642-001 Jan 31, 2005 7,879,349 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ENDO OPERATIONS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Nasal Spray 500 mcg/spray ➤ Subscribe 2017-04-28
➤ Subscribe Gel 1% ➤ Subscribe 2008-08-21
➤ Subscribe Extended-release Tablets 5 mg, 10 mg, 20 mg and 40 mg ➤ Subscribe 2007-11-23
➤ Subscribe Extended-release Tablets 30 mg ➤ Subscribe 2008-06-12
➤ Subscribe Gel 10 mg/actuation ➤ Subscribe 2012-08-14
➤ Subscribe Injection 250 mg/mL ➤ Subscribe 2014-06-11
➤ Subscribe Extended-release Tablets 7.5 mg and 15 mg ➤ Subscribe 2008-05-29
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2011-03-09

Supplementary Protection Certificates for Endo Operations Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0591280 01C0019 France ⤷  Get Started Free PRODUCT NAME: FROVATRIPTAN SUCCINATE MONOHYDRATE; NAT. REGISTRATION NO/DATE: NL 24548 20001212; FIRST REGISTRATION: FR - NL 24548 20001212
0591280 SPC/GB03/014 United Kingdom ⤷  Get Started Free PRODUCT NAME: 3 METHYLAMINO-6-CARBOXAMIDO-1, 2, 3, 4-TETRAHYDROCARBAZOLE ("FROVATRIPTAN") INCLUDING A SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: FR NL 24548 20001212; UK PL 16239/0017 20021007; UK PL 16239/0018 20021007
0591280 C300103 Netherlands ⤷  Get Started Free PRODUCT NAME: FROVATRIPTAN EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 27211RVG 27212 2002190419; FIRST REGISTRATION: NL 24548 20001212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Endo Operations – Market Position, Strengths & Strategic Insights

Last updated: January 3, 2026

Summary

Endo International plc is a prominent player in the global pharmaceutical landscape, primarily operating within specialty branded pharmaceuticals and generics markets. This analysis provides a comprehensive overview of Endo’s market position, operational strengths, competitive strategies, product portfolio, and future growth prospects. It emphasizes how Endo navigates challenges within a highly competitive, regulated environment and identifies strategic avenues for sustained expansion amid evolving industry dynamics.

Introduction

Endo operates across multiple therapeutic areas, including pain management, urology, and dermatology. With a focus on specialty pharmaceuticals, Endo's operations are characterized by a mix of innovation, strategic acquisitions, and a diversified product pipeline. As of 2022, Endo’s revenue primarily stems from North America, with international markets contributing progressively.

Market Overview

The pharmaceutical industry is marked by rapid innovation, patent expiries, and intense competition. Key drivers include evolving drug approval landscapes, pricing pressures, and digital transformation. Endo faces competition from both large pharmaceutical firms and niche players, emphasizing the need for strong operational execution and strategic agility.


What Is Endo’s Current Market Position?

Market Share & Revenue Breakdown

Metric 2022 Figures Notes
Global Revenue ~$2.63 billion Revenue decline of ~5% YoY attributed to patent cliffs and restructuring
North America Revenue ~$2.0 billion (~76%) Largest contributor, driven by pain management and urology products
International Revenue ~$630 million (~24%) Growth driven by emerging markets and portfolio expansion

Core Therapeutic Areas & Product Segments

Segment Major Products Market Position Key Competitors
Pain Management Lidoderm, Voltaren Leading in transdermal patches Pfizer (Negotiate), Novartis
Urology & Women's Health Androgel, Fortesta Top-tier US market share Abbott, Teva, Pfizer
Dermatology Benzaclin, Tactupump Niche but competitive Galderma, Valeant

Distribution & Market Penetration

Endo’s distribution channels include specialty pharmacies, hospitals, and retail pharmacies. Its robust footprint, especially in the US, solidifies its position, although regulatory hurdles and patent expiries threaten future dominance.


What Are Endo’s Strengths and Competitive Advantages?

Operational and Strategic Strengths

Strength Description Impact
Diversified Product Portfolio Combines branded, generic, and OTC assets Minimizes risk; buffers against patent losses
Strong Presence in Pain Management Portfolio of established brands Ensures steady revenue streams
Strategic Acquisitions Acquired Par Pharmaceuticals and other assets Expands market share, enhances R&D pipeline
Regulatory & Quality Compliance Maintenance of high standards Trust among physicians and pharmacies
Focus on Specialty Pharmaceuticals High-margin niche markets Improved profitability compared to generics

Market-driven Operational Strengths

  • Effective commercialization of complex formulations.
  • Focused R&D on high-value, specialty drugs.
  • Strategic geographic expansion, notably into China, Latin America, and Southeast Asia.

Financial Strengths

Metric 2022 Data Insights
EBITDA Margin ~23% Healthy profitability amid market challenges
R&D Investment ~$100 million Emphasizes innovation pipeline
Debt Levels Moderate, with strategic deleveraging Enables acquisition and operational agility

What Are Key Challenges Facing Endo?

Challenge Details Strategic Implications
Patent Expiries & Generics Competition Loss of exclusivity on flagship products Need for pipeline diversification
Regulatory & Litigation Risks Ongoing litigations on opioid-related lawsuits (notably in the US) Impact on financial stability
Pricing Pressures & Reimbursements Increasing governmental and payer scrutiny Necessitate value-based strategies
Market Saturation & Innovation Gap Slower pipeline development compared to large peers Critical focus area for R&D investments

How Does Endo’s Strategic Approach Position It for Future Growth?

Innovation & Pipeline Development

Endo prioritizes advancing its pipeline in pain management, urology, and dermatology. Highlights include:

  • New Chemical Entities (NCEs): Focused on niche formulations.
  • Biosimilars & Generics: Leveraging cost advantages.
  • Digital & Companion Diagnostics: Implementing tech for personalized therapy.

Market Expansion Strategies

  • Strengthening presence in emerging markets.
  • Expanding specialty distribution channels.
  • Forming strategic alliances to enhance R&D capabilities.

Operational Efficiency & Restructuring

  • Cost-cutting initiatives, including headcount reduction and process automation.
  • Divestment of non-core assets to optimize capital allocation.
  • Reorganisation of R&D to accelerate bringing innovative products to market.

How Does Endo Compare to Peers?

Company Key Strengths Market Cap (USD) Focus Areas Key Challenges
Endo Specialized niche, strong US presence ~$1.5 billion Pain, urology, dermatology Patent cliffs, litigations
Pfizer Diversified global portfolio, R&D prowess ~$220 billion Broad medicine spectrum Patent expiries, pricing pressures
Teva Generics pioneer, cost leadership ~$12 billion Generics, biosimilars Debt, patent cliff recovery
Novartis Innovation-driven, pipeline strength ~$210 billion Specialty, ophthalmology Pricing policies, patent cliffs

Note: Endo’s smaller scale affords agility but imposes limitations on large-scale R&D investments relative to giants like Pfizer or Novartis.


Future Outlook & Strategic Recommendations

Emerging Opportunities

  • Innovative Pain Therapies: Developing therapies targeting neuropathic pain and other high unmet needs.
  • Biosimilars & Generic Expansion: Capitalizing on patent expirations of major brands.
  • Digital Health Integration: Using digital platforms for outcomes monitoring.

Risks to Monitor

  • Growing regulatory and legal scrutiny, especially opioid-related cases.
  • Competitive moves from large pharmaceutical players.
  • Pricing reforms impacting profitability.

Recommended Strategic Focus

Focus Area Actions Expected Outcomes
Pipeline Acceleration Invest in novel formulations & delivery systems New revenue streams
Market Diversification Enter or expand in emerging markets Growth in high-growth regions
Operational Optimization Enhance manufacturing efficiency Cost savings
Legal & Regulatory Preparedness Robust compliance & litigation strategies Minimize legal risks

Key Takeaways

  • Endo maintains a strong foothold in niche, high-margin markets within the US, especially pain management and urology.
  • The company's diversified portfolio and strategic acquisitions provide resilience but face headwinds from patent expiries and legal challenges.
  • Emphasizing innovation, market expansion, and operational efficiency is vital for future growth.
  • Competitively, Endo benefits from agility and specialization but must navigate increased regulatory scrutiny and intensifying competition.
  • To sustain its positioning, Endo should focus on pipeline diversification, enter high-growth emerging markets, and leverage digital health.

FAQs

1. How vulnerable is Endo to patent expiries?
Endo’s revenue heavily relies on a few core products nearing patent cliffs, which pose significant risks. Diversification and pipeline development are critical to mitigate this vulnerability.

2. What are Endo’s most promising areas for future growth?
Pain management, biosimilars, and dermatological innovations offer substantial growth potential, especially as the company expands in emerging markets and invests in digital therapeutics.

3. How does Endo’s competitor landscape impact its strategy?
Large players like Pfizer and Novartis emphasize innovation and R&D, pressuring Endo to accelerate its pipeline and expand market share through strategic alliances and geographic expansion.

4. What legal challenges does Endo face?
Endo has faced opioid-related litigation in the US, which could result in significant financial liabilities and reputation impact, necessitating strong compliance and legal risk management.

5. What steps should Endo take to enhance its competitive edge?
Focusing on R&D acceleration, diversifying its product pipeline, expanding internationally, and adopting digital health tools will be crucial for preserving and enhancing its market position.


References

[1] Endo International Annual Report 2022.
[2] MarketWatch, Endo Pharmaceuticals Profile.
[3] IQVIA, Pharmaceutical Market Trends 2022.
[4] Reuters, Endo Litigation Updates.
[5] Bloomberg, Industry Competitive Analysis 2023.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.