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Last Updated: December 12, 2025

Accord Company Profile


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Summary for Accord

Drugs and US Patents for Accord

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare SPIRONOLACTONE spironolactone TABLET;ORAL 203512-003 Sep 19, 2016 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206434-002 Oct 31, 2016 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare REGADENOSON regadenoson SOLUTION;INTRAVENOUS 213236-001 Apr 11, 2022 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare DOCETAXEL docetaxel INJECTABLE;INJECTION 201195-005 Apr 20, 2012 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Accord Hlthcare TADALAFIL tadalafil TABLET;ORAL 209167-003 Oct 23, 2019 AB1 RX 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
Paragraph IV (Patent) Challenges for ACCORD drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01

Supplementary Protection Certificates for Accord Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3191475 LUC00372 Luxembourg ⤷  Get Started Free PRODUCT NAME: CRYSTALLINE FORMS OF 6-((6, 7-DIMETHOXYQUINAZOLIN-4-YL)OXY) - N,2-DIMETHYLBENZOFURAN-3-CARBOXAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/24/1827 20240625
2217577 7/2019 Austria ⤷  Get Started Free PRODUCT NAME: ALLOPURINOL UND LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180827
2217577 122019000008 Germany ⤷  Get Started Free PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2059246 2024C/552 Belgium ⤷  Get Started Free PRODUCT NAME: EEN COMBINATIE VAN (A) MACITENTAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN EN (B) TADALAFIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/24/1859 20240930
0536515 06C0031 France ⤷  Get Started Free PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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

Last updated: July 27, 2025

Introduction

Accord Healthcare has established itself as a significant player in the global pharmaceutical industry, primarily through its focus on high-quality generics and biosimilar products. The company's strategic positioning, operational strengths, and market penetration have contributed to its competitiveness against both multinational pharmaceutical giants and other generic manufacturers. This analysis assesses Accord’s market standing, core strengths, and provides strategic insights that can help stakeholders make informed decisions.

Accord’s Market Position

Global Footprint and Market Share

Founded in 2005, Accord Healthcare has rapidly expanded its global footprint, operating in over 80 countries across Europe, Asia, Africa, and the Americas [1]. Its presence in mature markets like Europe and North America, especially through the US subsidiary, Accord Healthcare Inc., enables it to tap into lucrative, high-margin segments for generic and biosimilar medicines.

Within the global generic drugs market, Accord is recognized among top-tier players, ranking in the top 10 most active generics suppliers in several key markets [2]. Its strategic focus on high-volume, high-demand therapeutic areas—such as oncology, cardiology, and infectious diseases—resonates with its objective to cement a resilient market presence.

Competitive Positioning

Unlike many competitors that primarily focus on mature markets or generic competition following patent expiry, Accord strategically invests in biosimilar R&D, aligning with current industry trends favoring biologics. Its early entry into biosimilars with products like infliximab and insulin has an increasing impact on its competitive differentiation [3].

Despite intense price competition in generics, Accord leverages cost efficiencies, strategic manufacturing, and robust regulatory compliance to maintain a competitive advantage. This balanced approach allows it to sustain margins while expanding volume.

Core Strengths of Accord

Manufacturing Excellence and Regulatory Compliance

Accord’s manufacturing facilities, especially its plants in India and Europe, meet stringent quality standards such as WHO-GMP, and US FDA approvals, ensuring access to regulated markets [4]. Its capacity to produce complex molecules, including biosimilars, demonstrates technical proficiency, reducing reliance on contract manufacturing and safeguarding quality controls.

Cost Leadership and Supply Chain Optimization

Accord’s vertically integrated supply chain and economies of scale contribute to competitive pricing, enabling aggressive market penetration. Its investments in advanced manufacturing technologies and process engineering reduce production costs and expedite time-to-market for new products.

Product Portfolio and R&D Investment

While primarily focused on generics, Accord has progressively diversified into biosimilars and complex specialty medicines. R&D investments have increased in recent years, aligning product pipeline expansion with evolving market demands, particularly in biosimilars—estimated to reach $55 billion by 2025 [5].

Strategic Partnerships and Market Access

Accord’s alliances with local distributors and government tenders facilitate market access, especially in emerging markets. Its proactive engagement with regulatory bodies accelerates approval timelines, offering a competitive edge.

Cost-Effective Regulatory Navigation

Accord’s experienced regulatory teams efficiently navigate complex approval pathways across jurisdictions, enabling faster entry into regulated markets—a critical advantage amid rising compliance costs globally.

Strategic Insights

Capitalizing on Biosimilars Growth

Accord’s early investments in biosimilar R&D position it favorably in a market expected to grow at a CAGR of 20% through 2025. Executing a focused strategy on high-value biologics, especially in autoimmune diseases and oncology, can lead to significant market share gains.

Digital and Supply Chain Innovation

Leveraging digital technologies, such as real-time supply chain tracking, AI-driven forecasting, and automation, can further optimize cost efficiencies and reduce lead times. This enhances responsiveness to market dynamics and demand fluctuations.

Portfolio Expansion and Strategic Alliances

Integrating emerging therapeutic areas like rare diseases and personalized medicine could diversify revenue streams. Collaborations with biotechnology firms and academic institutions could accelerate innovation, especially in novel biologics and complex generics.

Geographic Market Focus

Emerging markets like Africa and Southeast Asia offer growth opportunities driven by healthcare infrastructure expansion and increasing access initiatives. Tailoring product portfolios to local needs and forging public-private partnerships can maximize penetration.

Strengthening Regulatory and Patent Strategies

Expanding regulatory capabilities to include accelerated pathways (e.g., orphan drug designations) and patent litigations can protect market share and delay generic competition, ensuring sustained profitability.

Challenges and Competitive Risks

  • Pricing Pressure: Continued global discounting and tender-based procurement can erode margins.
  • Regulatory Hurdles: Stringent approval processes, especially for biosimilars, prolong product launch timelines.
  • Intellectual Property Barriers: Patent litigations in key markets may delay market entry for certain products.
  • Market Saturation: Competitor consolidation might intensify price wars and reduce available market segments.

Conclusion

Accord Healthcare’s strategic focus on quality manufacturing, cost leadership, and timely regulatory navigation positions it advantageously within the competitive pharmaceutical landscape. Its investments in biosimilars and emerging markets are poised to drive future growth, provided it continues to innovate and adapt to industry trends.

Stakeholders should monitor Accord’s pipeline developments, regional expansion strategies, and manufacturing innovations to assess long-term growth trajectories and competitive resilience.

Key Takeaways

  • Accord’s global footprint and diversified product portfolio strengthen its market positioning against competitors.
  • Investment in biosimilars aligns with industry growth trends and offers high-margin opportunities.
  • Operational efficiencies and strategic partnerships underpin its cost leadership.
  • Focused expansion into emerging markets and personalized medicine can unlock new revenue streams.
  • Continuous innovation and regulatory agility remain critical for maintaining competitive advantage amid industry challenges.

FAQs

1. What differentiates Accord Healthcare from other generic pharmaceutical companies?
Accord emphasizes high-quality manufacturing, early biosimilar investments, and a strategic global presence, enabling it to compete effectively in both generics and biologics.

2. How significant is Accord’s role in the biosimilars market?
Accord is emerging as a notable biosimilar manufacturer, with a growing pipeline targeting high-value biologics, positioning it to capture a substantial share as biosimilar adoption accelerates globally.

3. What strategic initiatives should Accord prioritize to sustain growth?
Priorities include expanding biosimilar R&D, strengthening regional market access, leveraging digital supply chain tools, and forging alliances for pipeline diversification.

4. What are the main risks facing Accord in the current pharmaceutical landscape?
Key risks include pricing pressures, regulatory hurdles, patent litigations, and market saturation, which could impact margins and growth prospects.

5. How can stakeholders leverage Accord’s strengths for investment decisions?
Investors should consider Accord’s growth in biosimilars, operational efficiencies, and regional expansion strategies as indicators of long-term value creation amid industry shifts.


Sources:

[1] Accord Healthcare Official Website. "Global Presence."
[2] IQVIA. "Top Generics Manufacturers."
[3] 글로벌 바이오시밀러 시장 전망 보고서 (2023).
[4] WHO-GMP Accreditation Reports.
[5] Grand View Research. "Biosimilars Market Forecast, 2025."

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