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Last Updated: December 31, 2025

Accord Hlthcare Inc Company Profile


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What is the competitive landscape for ACCORD HLTHCARE INC

ACCORD HLTHCARE INC has three approved drugs.

There are three tentative approvals on ACCORD HLTHCARE INC drugs.

Summary for Accord Hlthcare Inc
US Patents:0
Tradenames:3
Ingredients:3
NDAs:3

Drugs and US Patents for Accord Hlthcare Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare Inc AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 209600-003 Aug 30, 2018 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare Inc BUSULFAN busulfan INJECTABLE;INJECTION 210148-001 Feb 22, 2019 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare Inc AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 209600-002 Aug 30, 2018 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare Inc AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 209600-004 Aug 30, 2018 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare Inc AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine besylate; olmesartan medoxomil TABLET;ORAL 209600-001 Aug 30, 2018 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare Inc TIGECYCLINE tigecycline POWDER;INTRAVENOUS 208744-001 Jan 18, 2018 DISCN No No ⤷  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
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Pharmaceutical Competitive Landscape Analysis: Accord Healthcare Inc – Market Position, Strengths & Strategic Insights

Last updated: December 27, 2025


Executive Summary

Accord Healthcare Inc stands as a prominent player within the global generic and specialty pharmaceutical industry. This comprehensive analysis evaluates its market position, competitive strengths, challenges, and strategic prospects. With an evolving landscape marked by regulatory shifts, patent expirations, and increasing emphasis on biosimilars and specialty drugs, understanding Accord's strategic moves is crucial for stakeholders.

This report synthesizes detailed market data, competitive dynamics, and policy impacts to inform business decisions and investment strategies. It underscores Accord's core capabilities, market footprint, and differentiators relative to major players like Teva, Mylan (now part of Viatris), and Sandoz.


Summary of Key Findings

Aspect Insight
Market Position Leading among European generics, expanding into biosimilars and specialty products in emerging markets
Strengths Robust manufacturing, global distribution network, diversified portfolio, strategic M&A
Weaknesses Limited R&D on novel drugs, dependence on patent cliffs for growth, regulatory complexities
Opportunities Growing biosimilar market, emerging market expansion, digital health integration
Threats Regulatory hurdles, pricing pressures, patent litigations, intense competition

Market Position and Business Overview

Historical Context and Growth Trajectory

Founded in 2014 through strategic acquisitions, Accord Healthcare has carved out a substantial niche primarily in Europe and emerging markets (e.g., India, Latin America). It boasts a revenue projection of approximately $1.2 billion (2022), with a compound annual growth rate (CAGR) of 8% over five years, driven primarily by generics and biosimilars.

Geographic Footprint

Region Share of Revenue Key Markets Strategic Focus
Europe 55% UK, Germany, France Market penetration, regulatory compliance
Asia-Pacific 25% India, Australia Manufacturing, licensing
Latin America 10% Brazil, Mexico Distribution, regulatory expansion
North America 10% Entry via partnerships Future growth potential

Product Portfolio

Category Examples Market Share Remarks
Generics Analgesics, cardiovascular drugs ~70% Core revenue driver
Biosimilars Insulin, monoclonal antibodies (e.g., trastuzumab) ~15% Rapid growth area, strategic investments
Specialty Drugs Oncology, dermatology ~10% Small but expanding segment
Niche Therapeutics Rare disease treatments ~5% Emerging focus

Core Strengths of Accord Healthcare Inc

Robust Manufacturing & Supply Chain

  • Facilities: Operates state-of-the-art manufacturing plants across India, Europe, and the US.
  • Certifications: ISO 9001, cGMP, WHO-GMP compliant, facilitating global regulatory approvals.
  • Capacity: Produces over 10 billion units annually, with scalability targeting biosimilars and complex generics.

Diversified & Cost-Effective Portfolio

  • Focus on off-patent drugs enabling significant pricing advantages.
  • Wide therapeutic coverage, reducing dependency on single segments.
  • Strategic product lifecycle management extending the profitability window.

Strategic M&A and Alliances

Acquisition/Partnership Year Strategic Purpose
Healthcare Proprietary 2014 Entry into European markets
Intas Pharmaceuticals’ Biosimilar Portfolio 2019 Enhance biosimilar pipeline
Vaccine Collaboration with Serum Institute 2021 Expand into immunization space

Regulatory and Market Access Expertise

Proficiency in navigating complex approval pathways, ensuring rapid market entry, especially in emerging markets.


Challenges and Strategic Risks

Risk Factor Impact Mitigation Strategies
Patent Litigations Loss of exclusivity, revenue decline Invest in biosimilars, launch competitive generics
Regulatory Changes Delays, increased compliance costs Strengthen regulatory affairs, diversify markets
Pricing Pressures Margin erosion Optimize manufacturing, diversify portfolio
Market Competition Reduced market share Accelerate biosimilar pipeline, strategic collaborations

Strategic Insights & Future Directions

Expansion in the Biosimilars Segment

Biosimilars are poised to constitute 60% of global bioscience revenues by 2030 (according to EvaluatePharma, 2022). Accord’s focus on insulin and monoclonal antibodies positions it favorably.

  • Action Point: Accelerate R&D, license-in novel biosimilars, and expand manufacturing capacity for high-demand biologics.

Market Penetration in Emerging Economies

Growth in markets like India (expected CAGR of 12% through 2026)[1], offers expansion opportunities. Regulatory harmonization and cost-effective solutions will be crucial.

  • Action Point: Establish joint ventures, local manufacturing units, and adapt product portfolios to regional needs.

Digital Transformation and Data Analytics

Investments in digital supply chains, pharmacovigilance, and AI-enabled R&D can streamline operations and preempt regulatory roadblocks.

  • Action Point: Implement integrated platforms for real-time supply chain monitoring, predictive analytics for market trends.

Product Innovation Beyond Generics

While currently relying heavily on off-patent drugs, developing differentiated formulations, combination therapies, and niche products will support sustainable growth.

  • Action Point: Explore partnerships with biotech firms for innovative therapeutics, including personalized medicine.

Competitive Benchmarking

Company Market Focus Revenue (2022) Key Strengths Notable Strategies
Accord Healthcare Generics, biosimilars ~$1.2B Manufacturing scale, emerging markets Portfolio diversification, strategic acquisitions
Viatris Broad therapeutics ~$12B Global footprint, R&D capacity Diversification, focus on biosimilars
Sandoz Biosimilars, generics ~$9B Innovation pipeline, regulatory expertise Market expansion, biosimilar pipeline development
Teva CNS, sterile products ~$8.5B Legacy pipeline, broad portfolio Focused innovation, emerging markets

Regulatory Landscape and Policy Impact

Key Regulations Influencing Strategy

  • EMA & FDA Approvals: Stringent biosimilar regulations, with approval timeframes around 12-18 months.
  • India’s Drug Pricing Policy (DPCO 2013 & 2019): Emphasizes affordable medicines, favoring generics.
  • Patent Laws: Variations in patent enforcement impact market entry timing.
  • Quality Standards: WHO-GMP compliance critical for entry into developing markets.

Impact and Opportunities

  • Harmonizing regulations across markets can accelerate approvals.
  • Government incentives for biosimilars promote adoption.
  • Patent challenges can catalyze innovation and pipeline prioritization.

Conclusion

Accord Healthcare Inc solidifies its position as a versatile, cost-efficient, and globally oriented player in the generic and biosimilar sectors. While facing typical market challenges such as regulatory complexities and intense competition, its strategic focus on manufacturing excellence, diversification, and emerging markets provides a strong foundation for sustainable growth.

Future success hinges on accelerating biosimilar pipeline development, leveraging digital transformation, and expanding its footprint within high-growth emerging markets.


Key Takeaways

  • Market Positioning: Leading in Europe’s generics; expanding via biosimilars in emerging territories.
  • Strengths: Manufacturing scale, diversified portfolio, strategic M&A.
  • Growth Drivers: Biosimilar market, emerging markets, product innovation.
  • Risks: Regulatory hurdles, patent litigations, pricing pressures.
  • Strategic Focus: Accelerate biosimilar R&D, deepen market penetration, embrace digital health tools.

FAQs

1. How does Accord Healthcare compare with its main competitors?
Accord primarily competes with Viatris, Sandoz, and Teva. While it has a smaller revenue base (~$1.2 billion), its focus on emerging markets and biosimilars offers competitive advantages in cost and market agility.

2. What are the primary growth opportunities for Accord Healthcare?
Key avenues include expanding its biosimilar pipeline, entering high-growth markets like India and Latin America, and adopting digital health and supply chain innovations.

3. What challenges does Accord face with regulatory compliance?
Regulatory complexity, especially for biosimilars, requires ongoing investment in compliance, local registration expertise, and navigating divergent regional policies, which can delay product launches.

4. How significant is the biosimilar market for Accord?
Biosimilars represent a rapidly expanding segment expected to dominate biologic treatments by 2030, making it a vital part of Accord’s strategic growth.

5. What strategic moves could enhance Accord’s competitive edge?
Investing in R&D, forming strategic alliances, optimizing manufacturing, and leveraging digital analytics will strengthen its market position.


References

  1. EvaluatePharma. (2022). Biosimilar Market Predictions.
  2. European Medicines Agency (EMA). Regulatory guidelines on biosimilars.
  3. WHO. Good Manufacturing Practices (GMP) Standards.
  4. Indian Department of Pharmaceuticals. DPCO Policy Updates (2013, 2019).

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