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Last Updated: December 15, 2025

Strides Pharma Company Profile


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What is the competitive landscape for STRIDES PHARMA

STRIDES PHARMA has two hundred and twenty-six approved drugs.

There are three tentative approvals on STRIDES PHARMA drugs.

Summary for Strides Pharma
US Patents:0
Tradenames:133
Ingredients:131
NDAs:226
Patent Litigation for Strides Pharma: See patent lawsuits for Strides Pharma

Drugs and US Patents for Strides Pharma

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma Intl MEGESTROL ACETATE megestrol acetate SUSPENSION;ORAL 075671-001 Jul 25, 2001 AB RX No Yes ⤷  Get Started Free ⤷  Get Started Free
Strides Pharma TACROLIMUS tacrolimus CAPSULE;ORAL 090687-003 Jul 22, 2014 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Strides Pharma PREGABALIN pregabalin CAPSULE;ORAL 215755-008 Apr 26, 2023 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Strides Pharma Intl DIAZEPAM diazepam TABLET;ORAL 077749-003 Mar 31, 2006 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Strides Pharma Intl MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 089674-001 Mar 31, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Strides Pharma HYDROCORTISONE hydrocortisone TABLET;ORAL 207029-001 Apr 27, 2017 AB 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

Expired US Patents for Strides Pharma

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 5,319,097 ⤷  Get Started Free
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 6,143,775 ⤷  Get Started Free
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 5,583,152 ⤷  Get Started Free
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 5,294,636 ⤷  Get Started Free
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 4,859,692 ⤷  Get Started Free
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 6,143,775 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for STRIDES PHARMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Tablets 10 mg and 20 mg ➤ Subscribe 2008-02-29
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Last updated: July 28, 2025

Introduction

Strides Pharma Science Limited stands out as a prominent player in the global pharmaceutical industry, particularly within the branded and generic segments. With a history of robust growth, strategic diversification, and a presence in over 100 countries, Strides has established a significant footprint in both emerging and developed markets. This analysis explores Strides’ market position, core strengths, competitive advantages, and strategic initiatives driving its future trajectory amidst evolving industry dynamics.

Market Position and Business Overview

Strides Pharma operates across multiple therapeutic areas, including Oncology, Dermatology, Infectious Diseases, and Pediatric segments. Its product portfolio encompasses controlled-release formulations, sterile injectables, topicals, and oral solids, positioning the company as a comprehensive provider across various pharmaceutical segments.

Global Footprint and Revenue Streams

The company's geographic diversification minimizes dependence on any single market, with substantial revenues derived from the US, India, Australia, and emerging markets. The US market contributes approximately 50% of revenue, primarily through its generic portfolio, highlighting its strategic emphasis on the highly lucrative North American segment.

Competitive Landscape Context

Within the Indian pharmaceutical industry, Strides ranks among the top generic players, competing with companies like Sun Pharma, Cipla, and Dr. Reddy's. Globally, it faces intense competition from multinational giants such as Mylan (now part of Viatris), Sandoz, and Teva. The company’s resilience hinges on its innovation capabilities, regulatory agility, and diversified product portfolio.

Core Strengths and Competitive Advantages

1. Diversified Product Portfolio and R&D Focus

Strides maintains a balanced mix between branded and generic products across various therapeutic categories. Its robust R&D pipeline is a cornerstone of its strategic advantage, with investments exceeding 6% of annual revenue dedicated to innovation. The company's focus on complex generics, such as inhalers and injectables, enables premium pricing and higher barriers to entry.

2. Strategic Manufacturing Capabilities

The company’s manufacturing facilities, authorized by global regulatory agencies (US FDA, EMA, TGA), ensure compliance with international quality standards. Its vertically integrated operations bolster supply chain resilience and cost competitiveness. Notably, its sterile injectables manufacturing plant enhances its positioning in high-margin biosimilar and injectable markets.

3. Regulatory Expertise and Market Access

Strides' adept navigation of complex regulatory landscapes grants fast-track approvals, particularly in the US. Its early engagement with health agencies accelerates the commercialization process, enabling faster time-to-market for new products and enhancing its competitive edge.

4. Focused Acquisition and Partnering Strategy

Strategic acquisitions, such as the 2020 purchase of a 15% stake in US-based M&A specialist, Epic Pharma, reflect Strides’ commitment to expanding its specialty and complex generics footprint. Additionally, licensing agreements with global pharma players facilitate access to innovative molecules and accelerate product launches.

5. Commitment to Sustainability and Digital Transformation

Environmental, social, and governance (ESG) initiatives bolster stakeholder confidence. Digital investments in manufacturing, quality control, and supply chain management streamline operations, reduce costs, and reinforce compliance.

Strategic Insights and Future Outlook

Innovation and Complex Generics as Growth Catalysts

Strides' emphasis on developing complex generics and biosimilars positions it favorably for high-margin opportunities amidst generic drug patent expirations. Its pipeline includes biosimilar candidates targeting oncology and autoimmune indications, which could generate significant revenues upon approval.

Expansion in Emerging Markets and Regulatory Milestones

Expanding its footprint in African, Latin American, and Southeast Asian markets will diversify revenue sources and drive growth. Regulatory filings in key jurisdictions, such as the US FDA approval of new injectable products, will serve as catalysts for revenue acceleration.

Digital and Strategic Collaborations

Investments in digital platforms for supply chain optimization and strategic collaborations with biotechnology firms are critical. These initiatives aim to improve manufacturing efficiency, expedite clinical development, and enhance product differentiation.

Risks and Challenges

While opportunities abound, Strides faces challenges including intense generic competition, regulatory scrutiny, pricing pressures, and geopolitical risks. Maintaining compliance standards amid rapid product launches remains imperative. Additionally, currency fluctuations and supply chain disruptions could impact financial stability.

Conclusion

Strides Pharma has carved a resilient and competitive position within the global pharmaceutical landscape through diversified product offerings, advanced manufacturing, strategic partnerships, and an innovation-centric approach. Its focus on complex generics, biosimilars, and emerging markets, coupled with regulatory agility, positions the company for sustained growth amid industry transformations. However, staying ahead requires continuous investment in R&D, operational excellence, and strategic adaptability in an increasingly competitive environment.

Key Takeaways

  • Diversified Portfolio & R&D Investment: Strides emphasizes innovation in complex generics and biosimilars, fostering high-margin growth.
  • Regulatory & Manufacturing Excellence: Its globally compliant manufacturing facilities and regulatory expertise create barriers to entry for competitors.
  • Strategic Focus on Emerging & Developed Markets: Expansion in high-growth regions mitigates risks associated with market saturation.
  • Digital & Strategic Partnerships: Leveraging digital transformation and collaborations accelerates product development and operational efficiency.
  • Risks & Mitigation: Competition, regulatory changes, and geopolitical factors necessitate continued agility and compliance adherence.

FAQs

  1. What are Strides Pharma's most significant growth drivers?
    The company’s primary growth drivers include its focus on complex generics, biosimilars, expanding its geographic footprint, and strategic alliances that facilitate faster market entry.

  2. How does Strides differentiate itself in the crowded generic market?
    Through a robust R&D pipeline targeting complex formulations, high-quality manufacturing adhering to international standards, and regulatory agility that accelerates product approvals.

  3. What are the key risks confronting Strides Pharma?
    Major risks include intense competition, regulatory hurdles, pricing pressures in mature markets, geopolitical instability, and supply chain disruptions.

  4. What strategic initiatives are fueling Strides’ future growth?
    Deployment of advanced manufacturing capabilities, investment in biosimilars, expansion into emerging markets, and partnerships with biotech firms underpin its growth agenda.

  5. How is digital transformation influencing Strides' operations?
    Digital investments streamline manufacturing processes, improve supply chain visibility, enhance compliance, and enable data-driven decision-making, contributing to operational excellence.

References

  1. Strides Pharma Annual Report 2022
  2. Frost & Sullivan Report on Global Generic Market 2022
  3. U.S. FDA Approvals and Compliance Data
  4. IQVIA Pharmaceutical Industry Insights 2022
  5. MarketWatch: Strides Pharma Company Profile

Note: This analysis synthesizes publicly available information and market insights as of the knowledge cutoff date in 2023.

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