Last Updated: August 2, 2026

Strides Pharma Intl Company Profile


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Summary for Strides Pharma Intl
International Patents:10
US Patents:5
Tradenames:74
Ingredients:71
NDAs:108

Drugs and US Patents for Strides Pharma Intl

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 DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 076161-003 Jun 10, 2004 DISCN No No ⤷  Start Trial ⤷  Start Trial
Strides Pharma Intl LYVISPAH baclofen GRANULE;ORAL 215422-001 Nov 22, 2021 DISCN Yes No 11,850,225 ⤷  Start Trial Y ⤷  Start Trial
Strides Pharma Intl DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 205673-002 Oct 31, 2017 DISCN No No ⤷  Start Trial ⤷  Start Trial
Strides Pharma Intl SUMYCIN tetracycline hydrochloride TABLET;ORAL 061147-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Start Trial ⤷  Start Trial
Strides Pharma Intl ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 090598-002 Aug 11, 2010 DISCN No No ⤷  Start Trial ⤷  Start Trial
Strides Pharma Intl METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 077878-002 Aug 28, 2006 AB RX No No ⤷  Start Trial ⤷  Start Trial
Strides Pharma Intl LETROZOLE letrozole TABLET;ORAL 090789-001 Jun 3, 2011 DISCN No No ⤷  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

Expired US Patents for Strides Pharma Intl

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 5,612,367 ⤷  Start Trial
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 5,294,636 ⤷  Start Trial
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 4,859,692 ⤷  Start Trial
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 4,859,692 ⤷  Start Trial
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 5,319,097 ⤷  Start Trial
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 6,143,775 ⤷  Start Trial
Strides Pharma Intl ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 5,612,367 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for STRIDES PHARMA INTL drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 10 mg and 20 mg ➤ Subscribe 2008-02-29

Supplementary Protection Certificates for Strides Pharma Intl Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526171 SPC/GB01/047 United Kingdom ⤷  Start Trial PRODUCT NAME: NATEGLINIDE; REGISTERED: CH 55401 01 20000928; CH 55401 02 20000928; UK EU/1/01/174/001 20010403; UK EU/1/01/174/002 20010403; UK EU/1/01/174/003 20010403; UK EU/1/01/174/004 20010403; UK EU/1/01/174/005 20010403; UK EU/1/01/174/006 20010403; UK EU/1/01/174/007 20010403; UK EU/1/01/174/008 20010403; UK EU/1/01/174/009 20010403; UK EU/1/01/174/010 20010403; UK EU/1/01/174/011 20010403; UK EU/1/01/174/012 20010403; UK EU/1/01/174/013 20010403; UK EU/1/01/174/014 20010403; UK EU/1/01/174/015 20010403; UK EU/1/01/174/016 20010403; UK EU/1/01/174/017 20010403; UK EU/1/01/174/018 20010403; UK EU/1/01/174/019 20010403; UK EU/1/01/174/020 20010403; UK EU/1/01/174/021 20010403
1020461 C300482 Netherlands ⤷  Start Trial PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
1499331 122014000007 Germany ⤷  Start Trial PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
0480717 98C0022 France ⤷  Start Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0984957 122012000051 Germany ⤷  Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1507558 12C0033 France ⤷  Start Trial PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
1507558 C300528 Netherlands ⤷  Start Trial PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
>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.

Strides Pharma International: Market Position, Strengths & Strategic Insights

Last updated: February 20, 2026

What is Strides Pharma's Global Market Position?

Strides Pharma International is a mid-sized pharmaceutical company based in India with a focus on active pharmaceutical ingredients (APIs), formulations, and generic products. The company operates across North America, Europe, and emerging markets, with revenues reaching approximately $700 million in FY 2022. It ranks among the top 20 Indian pharmaceutical exporters and has a niche footprint in the oral solids, injectables, and topical segments.

In terms of market share, the company holds an estimated 2% share in the global generic formulations market. It is considered a key player within India's domestic sector, while its international presence is primarily within regulated markets, notably the US, through its strategic acquisitions and robust API supply chain.

Revenue Breakdown

Region Revenue (FY 2022) Percentage of Total Revenue Key Markets
North America $300 million 42.9% US, Canada
Europe $150 million 21.4% UK, Germany, France
Asia & ROW $250 million 35.7% India, emerging markets

What are Strides Pharma's Key Strengths?

1. Diversified Portfolio

Strides offers a broad product range across formulations, APIs, and biosimilars. Its formulations fleet includes over 600 products in multiple dosage forms, with significant focus on oral solids and injectables, which are high-growth segments.

2. API Manufacturing Capabilities

The company operates six manufacturing facilities approved by US FDA, European MHRA, and other regulatory bodies. It supplies APIs to major multinational pharmaceutical players, cementing its position as a key supplier within the global API market.

3. Strategic Acquisitions

Strides has acquired companies like WellSpring Pharmaceutical Corporation, expanding its US footprint and strengthening its injectable portfolio. This integration has enhanced its sales, regulatory, and manufacturing capabilities in regulated markets.

4. R&D Focus

Investing 6-8% of annual revenue into R&D, Strides develops complex generic formulations and biosimilars, including insulin analogs and monoclonal antibodies. Its pipeline includes 15 biosimilar development programs and numerous phase 1 and 2 generics projects.

What are the Strategic Challenges and Opportunities?

Challenges

  • Intense price competition in generics, especially in North America.
  • Regulatory pressures and delays in approval processes.
  • Manufacturing cost concerns and quality compliance.
  • Limited pipeline size compared to global top-tier players.

Opportunities

  • Expansion into biosimilars, including insulin and monoclonal antibodies.
  • Growth in emerging markets driven by affordability and tiered healthcare.
  • Strategic licensing agreements to access novel drug candidates.
  • Digital transformation initiatives to streamline R&D and supply chain.

How Does Strides Pharma Compare to Peers?

Company Market Focus Revenue (FY 2022) Regulatory Approvals Key Strengths
Dr. Reddy's Labs Generics, APIs $2.4 billion US, EU, Russia Diverse portfolio, global R&D presence
Aurobindo Pharma APIs, Generics $2.0 billion US, EU, Australia Vertical integration, cost competitiveness
Cipla Respiratory, Oncology $2.2 billion US, EU, South Africa Focus on complex formulations, innovation
Strides Pharma Formulations, APIs, Biosimilars $700 million US, EU, India API supply chain, niche biosimilar pipeline

What are the Key Strategic Recommendations?

  • Increase R&D investments to accelerate biosimilar pipeline development.
  • Expand manufacturing capacity in emerging markets for cost advantages.
  • Pursue targeted licensing and partnership deals in North America.
  • Strengthen regulatory compliance to speed approval processes.
  • Focus on next-generation delivery systems and digital supply chain.

What is the Outlook for Strides Pharma?

The company’s growth trajectory hinges on biosimilar advancements and API supply expansion. It faces competitive pressures from larger peers but has opportunities in biosimilars, emerging markets, and niche formulations. Strategic alliances and operational efficiencies could bolster its global presence.

Key Takeaways

  • Strides Pharma is a mid-sized player with a diversified portfolio and robust API capabilities.
  • Its revenue streams are concentrated in North America and Europe, with expansion in emerging markets.
  • The company's strengths include strategic acquisitions, a focus on biosimilars, and several FDA-approved manufacturing plants.
  • Challenges include regulatory delays and intense price competition, especially in generics.
  • Future growth depends on pipeline development, partnership formation, and operational expansion.

5 FAQs

1. How does Strides Pharma's revenue compare to its major competitors?
Strides generated approximately $700 million in FY 2022, significantly less than peers like Dr. Reddy’s, Aurobindo, and Cipla, which reported revenues exceeding $2 billion. Its niche focus limits scale but offers targeted growth opportunities.

2. What are the company's key regulatory markets?
Primarily the US, Europe, and India. It maintains FDA-approved manufacturing facilities and European certifications to access these markets.

3. Is Strides Pharma investing in biosimilars?
Yes, it has a pipeline of 15 biosimilar programs, including insulin and monoclonal antibodies, with clinical trials underway.

4. What are major risks for Strides Pharma?
Regulatory delays, pricing pressures in North America, and manufacturing cost control are primary risks.

5. What strategic moves could enhance its market position?
Investing in biosimilar R&D, expanding in emerging markets, and forging licensing agreements could improve competitive standing.


Citations

[1] Bloomberg Intelligence. (2023). Global Pharmaceutical Industry Reports.
[2] IQVIA. (2022). The Global Use of Medicines report.
[3] Strides Pharma Annual Report. (2022).
[4] U.S. Food and Drug Administration. (2022). Approved Facilities Directory.

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