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Last Updated: March 13, 2025

APOTEX Company Profile


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Summary for APOTEX

Drugs and US Patents for APOTEX

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Apotex Inc BALSALAZIDE DISODIUM balsalazide disodium CAPSULE;ORAL 077883-001 Dec 28, 2007 AB RX No No ⤷  Try for Free ⤷  Try for Free
Apotex Inc CILOSTAZOL cilostazol TABLET;ORAL 077030-002 Dec 10, 2004 AB RX No No ⤷  Try for Free ⤷  Try for Free
Apotex Inc MINOXIDIL (FOR MEN) minoxidil SOLUTION;TOPICAL 074924-001 Apr 29, 1998 DISCN No 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 3 of 3 entries

Expired US Patents for APOTEX

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Apotex PAXIL paroxetine hydrochloride CAPSULE;ORAL 020885-002 Oct 9, 1998 6,063,927*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 CAPSULE;ORAL 020885-003 Oct 9, 1998 4,721,723*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 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
1343782 122010000038 Germany ⤷  Try for Free PRODUCT NAME: PAZOPANIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/10/628/001-004 20100614
0817637 C300195 Netherlands ⤷  Try for Free PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDB AAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HEMISULFAAT, EN LAMIV UDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT; REGISTRTION NO/DATE: EU/04/298/001-002 20041217
2924034 PA2019507 Lithuania ⤷  Try for Free PRODUCT NAME: DORAVIRINAS ARBA JO DRUSKA, LAMIVUDINAS ARBA JO DRUSKA, TENOFOVIRAS ARBA JO ESTERIS, YPAC DIZOPROKSILO ESTERIS ARBA JO DRUSKA, YPAC FUMARATO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1333 20181122
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 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

In the ever-evolving pharmaceutical industry, Apotex stands out as a major player with a strong focus on generic medications and biosimilars. As Canada's largest pharmaceutical company, Apotex has made significant strides in improving access to affordable medicines worldwide. Let's delve into the company's market position, strengths, and strategic insights to understand its competitive landscape better.

Apotex's Market Position

Apotex has established itself as a formidable force in the pharmaceutical industry, particularly in the generic drug sector. The company's market position is characterized by its extensive global reach and impressive production capabilities.

Global Presence

Apotex's operations span across multiple countries, showcasing its international influence:

  • Exports to more than 115 countries[3]
  • Operations in over 45 countries[8]
  • Presence in the Americas, Europe, the Middle East, Africa, and Asia Pacific[9]

This widespread global presence allows Apotex to adapt to diverse market demands and capitalize on emerging opportunities in various regions.

Production Capacity

The company's manufacturing prowess is evident in its impressive production figures:

  • Produces 25 billion dosages annually[3]
  • Manufactures over 300 generic pharmaceuticals in more than 4,000 dosages and formats[3]
  • Fills 1 in 5 prescriptions in Canada – the largest amount of any company in the country[3]

These statistics highlight Apotex's significant market share and its ability to meet large-scale pharmaceutical demands.

Apotex's Key Strengths

Apotex's competitive edge stems from several key strengths that have propelled its growth and market dominance.

Research and Development Focus

Apotex places a strong emphasis on innovation and product development:

  • Invested over $2 billion in research and development in the past decade[5]
  • Launches more than 60 new products every year[5]

This commitment to R&D ensures a steady pipeline of new products, keeping Apotex at the forefront of pharmaceutical advancements.

Manufacturing Excellence

The company's manufacturing capabilities are a cornerstone of its success:

  • Seven world-class manufacturing sites with a capacity to produce 25 billion finished doses annually[5]
  • Three world-class active pharmaceutical ingredients (API) manufacturing sites[5]
  • Investments of more than $1 billion in manufacturing and commercial operations over the last five years[5]

These state-of-the-art facilities and substantial investments underscore Apotex's commitment to quality and efficiency in production.

Diverse Product Portfolio

Apotex boasts a comprehensive range of pharmaceutical offerings:

  • Generic pharmaceuticals
  • Biosimilars
  • Active pharmaceutical ingredients
  • Consumer health products[7]

This diversified portfolio allows Apotex to cater to various market segments and mitigate risks associated with reliance on a single product category.

Strategic Insights

Apotex's strategic approach to the pharmaceutical market reveals several key insights that contribute to its competitive positioning.

Focus on Affordability and Access

"We improve everyday access to affordable, innovative medicines and health products for patients and consumers worldwide."[1]

This mission statement underscores Apotex's commitment to making medicines accessible and affordable, a strategy that resonates well in both developed and emerging markets.

Expansion into Specialty Branded Pharmaceuticals

Apotex is strategically expanding its presence in the specialty branded pharmaceutical market:

  • Acquired Searchlight Pharma, adding a diverse portfolio of over 60 products[6]
  • Acquired exclusive rights to certain branded ophthalmic products from Harrow, Inc.[6]

These acquisitions demonstrate Apotex's intent to diversify beyond its core generics business and capture higher-margin opportunities in specialty pharmaceuticals.

Vertical Integration

Apotex's business model includes vertical integration:

  • Owns and operates manufacturing facilities[2]
  • Produces active pharmaceutical ingredients (API) through its Global Active Pharmaceutical Ingredients (GAPI) division[3]

This integrated approach allows for better control over the supply chain, ensuring quality and potentially reducing costs.

Strategic Partnerships and Acquisitions

Apotex actively pursues growth through strategic partnerships and acquisitions:

  • Positioned as a partner of choice for pharmaceutical licensing and acquisition opportunities in the Americas[6]
  • Recent acquisitions include CanPrev and US rights to PROVIGIL and NUVIGIL[9]

These strategic moves enable Apotex to expand its product portfolio and market reach rapidly.

Competitive Landscape

To fully appreciate Apotex's position, it's crucial to understand its standing within the competitive landscape.

Market Share

While specific market share figures are not provided in the search results, Apotex's significant production capacity and its claim to fill 1 in 5 prescriptions in Canada indicate a substantial market share, particularly in its home market.

Key Competitors

The pharmaceutical industry is highly competitive, with several major players vying for market share. While the search results don't provide a comprehensive list of Apotex's competitors, they do mention some companies for comparison:

  • Liminal BioSciences Inc (Canada)
  • Duchesnay Inc (Canada)
  • Eloxx Pharmaceuticals Inc (USA)
  • Resilience Biotechnologies Inc (USA)[9]

It's important to note that Apotex's competitors would likely include other major generic drug manufacturers and pharmaceutical companies operating globally.

Competitive Advantages

Apotex's competitive advantages include:

  1. Strong Canadian roots and market leadership
  2. Extensive global reach
  3. Significant manufacturing capacity
  4. Diverse product portfolio spanning generics, biosimilars, and branded products
  5. Vertical integration, including API production
  6. Focus on affordability and accessibility

These advantages position Apotex favorably in the competitive pharmaceutical landscape.

Challenges and Opportunities

Like any pharmaceutical company, Apotex faces both challenges and opportunities in the evolving market landscape.

Challenges

  1. Regulatory hurdles: The pharmaceutical industry is heavily regulated, and Apotex must navigate complex and changing regulations across multiple markets[2].
  2. Patent disputes: The company has been involved in several patent disputes, which can impact its ability to market certain generic products[2].
  3. Pricing pressures: Increasing product price pressure is a significant challenge in the generic drug market[4].
  4. Currency fluctuations: Given its global operations, Apotex is exposed to risks associated with currency exchange rate fluctuations[2].

Opportunities

  1. Emerging markets: There's potential for expansion into emerging markets with growing healthcare needs[2].
  2. Biosimilars: The biosimilar market presents significant growth opportunities, and Apotex is well-positioned with its Apobiologix division[3].
  3. Strategic collaborations: Partnerships with other pharmaceutical companies can provide access to new technologies and research[2].
  4. Specialty branded pharmaceuticals: The recent acquisitions in this space open up new growth avenues for Apotex[6].

Future Outlook

Apotex's future outlook appears promising, driven by several factors:

  1. Continued focus on R&D and new product launches
  2. Strategic expansion into specialty branded pharmaceuticals
  3. Potential for further acquisitions and partnerships
  4. Ongoing commitment to improving access to affordable medicines

The company's diverse portfolio, global presence, and strategic initiatives position it well for continued growth and market leadership.

Key Takeaways

  • Apotex is Canada's largest pharmaceutical company with a significant global presence.
  • The company's strengths lie in its manufacturing excellence, R&D focus, and diverse product portfolio.
  • Apotex is strategically expanding beyond generics into specialty branded pharmaceuticals.
  • Vertical integration and strategic partnerships are key components of Apotex's business model.
  • While facing challenges such as regulatory hurdles and pricing pressures, Apotex has significant opportunities in emerging markets and biosimilars.
  • The company's future outlook is positive, supported by its strategic initiatives and commitment to affordable medicine access.

FAQs

  1. What is Apotex's main focus in the pharmaceutical industry? Apotex primarily focuses on developing and manufacturing generic pharmaceuticals, biosimilars, and active pharmaceutical ingredients, with a recent expansion into specialty branded pharmaceuticals.

  2. How does Apotex contribute to global healthcare? Apotex improves access to affordable medicines worldwide by producing high-quality generic drugs and biosimilars, exporting to over 115 countries, and launching numerous new products annually.

  3. What sets Apotex apart from its competitors? Apotex's competitive advantages include its strong Canadian roots, extensive global reach, significant manufacturing capacity, diverse product portfolio, vertical integration, and focus on affordability and accessibility.

  4. How is Apotex adapting to changes in the pharmaceutical market? Apotex is adapting by expanding into specialty branded pharmaceuticals, investing heavily in R&D, pursuing strategic acquisitions and partnerships, and maintaining a focus on emerging markets and biosimilars.

  5. What are the main challenges Apotex faces in the current market? Key challenges for Apotex include navigating complex regulatory environments, managing patent disputes, addressing pricing pressures in the generic drug market, and mitigating risks associated with global currency fluctuations.

Sources cited: [1] https://www.apotex.com/ca/en/about-us/our-purpose [2] https://www.coursehero.com/file/212504844/Assignment-5-bussiness-swot-reportdocx/ [3] https://careers.apotex.com/content/What-We-Have-Created/?locale=en_US [4] https://www.businesswire.com/news/home/20211229005207/en/Insights-on-the-Branded-Generics-Global-Market-to-2026---Featuring-Apotex-AstraZeneca-and-Pfizer-Among-Others---ResearchAndMarkets.com [5] https://www.apotex.com/us/about-us/our-operations [6] https://www.apotex.com/ca/en/about-us/news/2024/04/02/apotex-to-acquire-searchlight-pharma--a-canadian-specialty-branded-pharmaceutical-leader [7] https://www.apotex.com/us/about-us/our-purpose [8] https://www.coursehero.com/file/57962118/Company-Analysis-of-Apotexdocx/ [9] https://www.globaldata.com/company-profile/apotex-inc/

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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.