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

Last Updated: July 29, 2025

Apotex Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Apotex

Drugs and US Patents for Apotex

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Apotex AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712-001 Apr 28, 2017 AB RX No Yes ⤷  Try for Free ⤷  Try for Free
Apotex DASATINIB dasatinib TABLET;ORAL 203180-001 Nov 23, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free
Apotex Corp LOSARTAN POTASSIUM losartan potassium TABLET;ORAL 090790-003 Oct 6, 2010 DISCN No No ⤷  Try for Free ⤷  Try for Free
Apotex OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 076048-002 Oct 22, 2007 AB RX No No ⤷  Try for Free ⤷  Try for Free
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-002 Feb 16, 1999 AB RX Yes No ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Expired US Patents for Apotex

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 6,172,233*PED ⤷  Try for Free
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-004 Oct 9, 1998 6,063,927*PED ⤷  Try for Free
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-001 Dec 29, 1992 6,063,927*PED ⤷  Try for Free
Apotex PAXIL paroxetine hydrochloride TABLET;ORAL 020031-002 Dec 29, 1992 6,172,233*PED ⤷  Try for Free
Apotex PAXIL CR paroxetine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936-003 Dec 6, 2000 6,133,289*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries
Paragraph IV (Patent) Challenges for APOTEX drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Extended-release Tablets 25 mg ➤ Subscribe 2005-09-09
➤ Subscribe Oral Suspension 10 mg/5 mL ➤ Subscribe 2005-02-10
➤ Subscribe Extended-release Tablets 37.5 mg ➤ Subscribe 2009-05-19

Supplementary Protection Certificates for Apotex Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1419152 122012000038 Germany ⤷  Try for Free PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
1559427 13C0032 France ⤷  Try for Free PRODUCT NAME: MIRABEGRON ET SES SELS; REGISTRATION NO/DATE: EU/1/12/809/001 20130107
0489070 300162 Netherlands ⤷  Try for Free PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920
0780390 PA2004012,C0780390 Lithuania ⤷  Try for Free PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-1,4-DIHIDRO-8-METOKSI-7-((4AS, 7AS)-OKTAHIDRO-6H-PIROLO(3,4-B)PIRIDIN-6-IL)-4-OKSO-3-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
0467488 SPC/GB00/019 United Kingdom ⤷  Try for Free PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Last updated: July 27, 2025


Introduction

Apotex Inc. stands as Canada's largest pharmaceutical manufacturer, specializing in the development, manufacturing, and distribution of generic and biosimilar drugs. As the pharmaceutical landscape evolves with increasing innovation and regulatory complexity, Apotex navigates these dynamics by leveraging its market position, operational strengths, and strategic initiatives. This analysis delineates Apotex’s standing within global and regional markets, explores its core strengths, identifies competitive challenges, and outlines strategic pathways to reinforce its position amidst intensifying competition.


Market Position

Global Footprint and Revenue Streams

Apotex operates in over 100 countries, with a robust presence across North America, Latin America, Asia, and select European markets. Its revenue predominantly stems from the generic drug segment, which accounts for approximately 60-70% of total sales, supplemented by biosimilars and branded pharmaceuticals. In 2022, Apotex reported revenues nearing CAD 1.2 billion, reflecting steady growth driven by targeted product launches and strategic acquisitions [1].

Competitive Landscape

Within the generic pharmaceutical space, Apotex is ranked among the top ten global providers. Its key competitors include Teva Pharmaceuticals, Sandoz (Novartis), Mylan (now part of Viatris), and Lupin. Unlike some peers, Apotex emphasizes a strategic balance between manufacturing capacity and R&D to diversify its offerings, particularly focusing on biosimilars—a segment experiencing rapid growth given recent patent expirations.

Regulatory and Patent Challenges

Like other generics players, Apotex faces patent litigations and regulatory hurdles, notably in the US and EU markets, where patent disputes are common before gaining market approval. Its ability to secure ANDA (Abbreviated New Drug Application) approvals and navigate these challenges influences its competitive timeline and market share expansion.


Strengths

Manufacturing Capabilities and Quality Standards

Apotex’s vertically integrated manufacturing facilities demonstrate high operational efficiency, with facilities accredited by regulatory authorities including the FDA, EMA, and Health Canada. Its extensive quality assurance (QA) systems afford it a competitive edge, enabling rapid approval cycles for generic and biosimilar products.

R&D Focus in Biosimilars

A strategic pivot toward biosimilars positions Apotex for sustainable growth amid patent cliffs. Its pipeline comprises biosimilar candidates targeting oncology, autoimmune, and inflammatory diseases, aligning with industry trends toward biologics. The company's investment in analytical tools and clinical development capabilities facilitates accelerated biosimilar approvals.

Cost Leadership and Market Access

Apotex maintains cost efficiency through its integrated supply chain and strategic sourcing, allowing competitive pricing without compromising quality. Its extensive distribution network and presence in emerging markets bolster access to price-sensitive segments.

Intellectual Property Strategy

While navigating patent litigations, Apotex adopts proactive licensing, collaborations, and strategic acquisitions to mitigate risks. Its emphasis on developing a diverse product portfolio reduces dependence on key patents and enhances resilience.


Strategic Insights

Innovation and Investment in Biosimilars

Given the expiration of patents for blockbuster biologics such as Humira and Enbrel, biosimilars present lucrative opportunities. Apotex should amplify R&D investment to expedite biosimilar development, especially focused on novel molecular pathways and delivery mechanisms. Establishing collaborations with biotech firms and academic institutions can catalyze innovation.

Geographic Expansion in Emerging Markets

Emerging economies (e.g., India, Latin America, Southeast Asia) present fewer regulatory barriers and larger demand for affordable medicines. Apotex should deepen market penetration through local manufacturing partnerships, joint ventures, or licensing agreements to capture market share and diversify revenue streams.

Digital Transformation

Adopting advanced manufacturing analytics, quality systems, and digital supply chain management can improve efficiencies and compliance. Implementing AI-driven R&D platforms enhances candidate screening and accelerates time-to-market for biosimilars and generics.

Regulatory and Patent Strategy Optimization

Proactive patent landscape analysis and strategic patent filings can mitigate litigations and extend market exclusivity. Developing a global regulatory affairs team can streamline approval processes across key markets, reducing time-to-market gaps.

Mergers & Acquisitions (M&A) and Strategic Alliances

Engaging in M&A to acquire niche generics portfolios or biosimilar assets accelerates growth. Forming alliances with biotech firms and research institutions fosters innovation and access to advanced technologies.


Competitive Challenges

  • Intensifying R&D Costs: High investments needed for biosimilar development and regulatory compliance can impede margins.
  • Patent Litigation Risks: Patent challenges and litigation delays can hinder timely market entry.
  • Regulatory Complexity: Evolving global regulatory standards increase costs and extend timeframes.
  • Market Consolidation: Larger players pursuing aggressive M&A strategies threaten market share stability.
  • Pricing Pressure: Governments and payers implement price controls which constrain profit margins.

Concluding Remarks

Apotex’s strategic positioning leverages its manufacturing prowess, regulatory expertise, and biosimilar pipeline to remain competitive. To sustain growth amid patent expirations and market commoditization, the firm must intensify innovation, expand geographically, enhance operational efficiencies, and foster strategic partnerships. Its adaptability to regulatory changes and commitment to quality underpin its resilience in a consolidating industry.


Key Takeaways

  • Apotex maintains a strong market position as a leading North American generic and biosimilar producer, with a growing international footprint.
  • Its strengths include integrated manufacturing, high-quality standards, and a strategic focus on biosimilars aligned with industry shifts.
  • Future growth hinges on increased investment in biosimilar R&D, geographic expansion into emerging markets, and digital transformation initiatives.
  • Effective patent management and regulatory navigation remain critical to minimizing legal risks and expediting product launches.
  • Strategic M&A and alliances will be instrumental in diversifying product offerings and accelerating innovation.

FAQs

  1. What are Apotex’s primary growth areas?
    Apotex’s primary growth drivers include biosimilars development, expansion into emerging markets, and strategic innovation in manufacturing and R&D.

  2. How does Apotex stay competitive against larger pharmaceutical firms?
    By emphasizing cost efficiency, high-quality manufacturing, targeted biosimilar pipelines, and strategic regional expansion, Apotex maintains competitiveness.

  3. What challenges does Apotex face in the biosimilar market?
    Challenges include high R&D costs, complex regulatory pathways, patent litigations, and market acceptance hurdles.

  4. What strategies should Apotex adopt to mitigate patent litigation risks?
    Proactive patent landscape analysis, diversified portfolio development, licensing agreements, and strategic filings can reduce litigation risks.

  5. In which regions should Apotex focus its expansion efforts?
    Apotex should prioritize emerging markets such as India, Latin America, and Southeast Asia for growth, leveraging local partnerships and manufacturing facilities.


Sources

[1] Apotex Annual Report 2022.

More… ↓

⤷  Try for 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. 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.