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Last Updated: December 15, 2025

Astrazeneca Company Profile


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Summary for Astrazeneca

Drugs and US Patents for Astrazeneca

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 DISCN Yes No 8,628,799 ⤷  Get Started Free Y ⤷  Get Started Free
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes 11,903,955*PED ⤷  Get Started Free Y ⤷  Get Started Free
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No 8,361,972*PED ⤷  Get Started Free Y ⤷  Get Started Free
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-002 May 2, 2019 DISCN Yes No 8,716,251*PED ⤷  Get Started Free Y ⤷  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 Astrazeneca

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 6,369,085*PED ⤷  Get Started Free
Astrazeneca PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-002 Aug 8, 2000 6,598,603*PED ⤷  Get Started Free
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 4,738,974*PED ⤷  Get Started Free
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 9,198,925 ⤷  Get Started Free
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 6,479,065 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ASTRAZENECA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe HydrochlorideExtended-release Tablets 2.5 mg/1000 mg ➤ Subscribe 2018-10-29
➤ Subscribe Nasal Spray 0.032 mg (32 mcg)/spray ➤ Subscribe 2007-05-14
➤ Subscribe Delayed-release for Oral Suspension 2.5 mg and 5 mg ➤ Subscribe 2018-09-24
➤ Subscribe Injection 50 mg/mL, 2.5 mL and 5 mL syringe ➤ Subscribe 2009-10-01
➤ Subscribe Inhalation Suspension 1 mg/2 mL ➤ Subscribe 2010-05-28
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2012-03-30
➤ Subscribe Tablets 60 mg ➤ Subscribe 2015-09-30
➤ Subscribe Tablets 500 mcg ➤ Subscribe 2015-03-02
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe 2013-07-31
➤ Subscribe Tablets 2.5 mg and 5 mg ➤ Subscribe 2013-07-31
➤ Subscribe Delayed-release 20 mg and 40 mg ➤ Subscribe 2005-08-05
➤ Subscribe For Injection 20 mg/vial and 40 mg/vial ➤ Subscribe 2009-11-23
➤ Subscribe Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL ➤ Subscribe 2005-09-15
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 2007-03-19
➤ Subscribe Tablets 90 mg ➤ Subscribe 2015-07-20
➤ Subscribe Tablets 5 mg, 10 mg, 20 mg and 40 mg ➤ Subscribe 2007-08-13
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 2014-06-11

Supplementary Protection Certificates for Astrazeneca Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1482932 648 Finland ⤷  Get Started Free
0823900 C300429 Netherlands ⤷  Get Started Free PRODUCT NAME: GEFITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/526/00156154 2009020624
0823900 PA2009009,C0823900 Lithuania ⤷  Get Started Free PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
2465580 SPC/GB21/030 United Kingdom ⤷  Get Started Free PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
1261586 SZ 4/2010 Austria ⤷  Get Started Free PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
>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: ASTRAZENECA – Market Position, Strengths & Strategic Insights

Last updated: October 15, 2025

Introduction

AstraZeneca PLC stands as a global leader in the biopharmaceutical industry, renowned for its innovative portfolio spanning oncology, cardiovascular, respiratory, and autoimmune diseases. With a robust pipeline and strategic focus, AstraZeneca continues to carve a competitive niche in an increasingly complex pharmaceutical landscape. This analysis examines AstraZeneca’s market position, core strengths, and strategic initiatives, providing critical insights for stakeholders seeking informed engagement with the company’s future trajectory.

Market Position Overview

AstraZeneca ranks among the top-tier global pharmaceutical companies, consistently positioning itself within the top ten by revenue. In 2022, the company's revenue surpassed $44 billion, reflecting its resilient growth amid rising competition and patent expirations (source: Company Annual Report 2022). The company's geographic footprint encompasses North America, Europe, Asia-Pacific, and emerging markets, with the United States accounting for approximately 45% of sales, underscoring its strong foothold in key markets (Financial Times, 2022).

AstraZeneca’s diverse portfolio yields strategic resilience; notably, the company experienced a revenue boost from its COVID-19 vaccine, Vaxzevria, while maintaining a focus on its core therapeutic areas. The oncology division now accounts for nearly 60% of revenues, positioning AstraZeneca as a dominant oncological innovator.

Competitive Positioning in Key Therapeutic Areas

  • Oncology: AstraZeneca’s oncology pipeline is among the most vigorous globally, with blockbuster drugs like Tagrisso (osimertinib), Imfinzi (durvalumab), and Lynparza (olaparib). The company leads the immuno-oncology segment, leveraging a combination of targeted therapies and immune checkpoint inhibitors.
  • Cardiovascular & Renal: The company continues to innovate in hypertension and heart failure, with Farxiga (dapagliflozin) cementing its position in diabetes management.
  • Respiratory & Autoimmune: While competitive, AstraZeneca’s newer molecules aim to expand its footprint in asthma and COPD.

The strategic pivot away from its previous focus on non-core assets into high-growth, specialty therapy domains underscores AstraZeneca’s ambition to sustain competitive advantage.

Strengths Driving Competitive Edge

1. Robust R&D Innovation

AstraZeneca invests approximately 20% of its revenue into R&D, enabling a pipeline with over 120 ongoing clinical trials. The company’s emphasis on precision medicine and immunotherapy has positioned it at the forefront of oncology breakthroughs ([1]).

2. Strategic Collaborations and Partnerships

AstraZeneca’s strategic alliances bolster innovation and market access. Notable collaborations include partnerships with Merck & Co. on immunotherapies and with Daiichi Sankyo on ascending antibody-drug conjugates. These alliances expand scientific capacity and accelerate product development.

3. Diversified Portfolio & Focused Therapeutic Areas

While heavily invested in oncology, AstraZeneca’s diversified portfolio mitigates risks associated with patent cliffs. Its presence across cardiovascular, respiratory, and immunological domains fosters stability amid market fluctuations.

4. Geographic Expansion

The company’s strategic expansion into emerging markets, especially in Asia and Latin America, provides access to high-growth populations. Approaches include tailored pricing strategies and regional partnerships.

5. Advanced Manufacturing & Supply Chain Capabilities

AstraZeneca’s global manufacturing footprint ensures supply chain resilience, essential during pandemic-driven disruptions. Such infrastructure supports rapid response to global health crises.

Strategic Initiatives and Future Outlook

1. Focused Investment in Oncology & Immunotherapy

AstraZeneca’s pipeline emphasizes immunotherapy, targeted treatments, and bispecific antibodies, such as Enhertu (trastuzumab deruxtecan) through collaboration with Daiichi Sankyo. The company's recent acquisitions and licensing deals aim to strengthen its oncology offerings ([2]).

2. Digital Transformation & Data-Driven Drug Development

AstraZeneca leverages artificial intelligence, machine learning, and real-world evidence to facilitate drug discovery, trial design, and personalized treatment solutions. These initiatives enhance productivity and reduce time-to-market.

3. Emphasis on Precision Medicine

Integrating genetic insights into product development secures AstraZeneca’s leadership in personalized therapies, especially in oncology where biomarker-driven approaches dominate.

4. Commitment to Sustainability and Access

The company’s environmental initiatives, including carbon neutrality targets and equitable access programs, align with stakeholder expectations and bolster its corporate reputation.

5. Rapid Response to Emerging Health Challenges

AstraZeneca remains agile in addressing unmet needs, exemplified by its COVID-19 vaccine deployment and ongoing research into infectious diseases.

Challenges and Risks

Despite its strengths, AstraZeneca faces inherent threats:

  • Intense Competition: From firms such as Pfizer, Roche, Merck, and Novartis, especially in high-growth areas like immuno-oncology.
  • Regulatory Dynamics: Evolving regulatory frameworks could impede drug approvals or lead to increased compliance burdens.
  • Patent Expirations: Although diversification mitigates this, patent cliffs remain a concern in flagship products.
  • Pricing & Reimbursement Pressures: Public and governmental pushback on drug prices could impact profitability.

Conclusion

AstraZeneca’s strategic positioning within the global pharmaceutical landscape is underpinned by its innovation-driven culture, diversified portfolio, strategic collaborations, and expanding geographic footprint. While facing considerable competitive and regulatory pressures, the company's focus on oncology, immunotherapy, and personalized medicine, along with its commitment to digital transformation and sustainability, positions it favorably for sustained growth.

Key Takeaways

  • Market Leadership: AstraZeneca maintains a formidable presence, particularly in oncology, with a growing footprint in immunotherapy.
  • Innovation Focus: Heavy R&D investment and strategic partnerships underpin a robust pipeline poised for future growth.
  • Geographic Diversification: Expansion into emerging markets offers significant revenue opportunities.
  • Strategic Adaptability: Prioritization of high-growth therapeutic areas and digital initiatives fortify competitiveness.
  • Risks & Mitigation: Continuous innovation, portfolio diversification, and adaptive regulatory strategies are critical for mitigating market threats.

FAQs

1. How does AstraZeneca compare to its competitors in oncology?
AstraZeneca leads in targeted cancer therapies and immuno-oncology, notably with drugs like Tagrisso and Imfinzi. Its pipeline emphasizes precision medicine, positioning it ahead of some rivals in innovative treatments.

2. What are AstraZeneca’s primary growth drivers?
Key growth drivers include its oncology portfolio, expanding immunotherapy offerings, strategic collaborations, and expansion into emerging markets.

3. How does AstraZeneca address regulatory challenges?
The company proactively engages with regulatory agencies, maintains compliance rigorously, and leverages data-driven approaches to expedite approvals without compromising standards.

4. What is AstraZeneca’s approach to digital transformation?
AstraZeneca invests in AI, machine learning, and real-world data analytics to streamline R&D processes, optimize clinical trials, and develop personalized therapies.

5. What are the main risks facing AstraZeneca in the coming years?
Primary risks include intense competition, patent expirations, regulatory hurdles, pricing pressures, and geopolitical uncertainties impacting global operations.


References

[1] AstraZeneca Annual Report 2022.
[2] Financial Times. AstraZeneca’s Oncology Strategy. 2022.

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