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Last Updated: April 3, 2026

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 XYLOCAINE lidocaine hydrochloride INJECTABLE;INJECTION 010418-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Astrazeneca KOSELUGO selumetinib sulfate GRANULE;ORAL 219943-002 Sep 10, 2025 RX Yes Yes 9,156,795 ⤷  Start Trial Y Y ⤷  Start Trial
Astrazeneca CALQUENCE acalabrutinib maleate TABLET;ORAL 216387-001 Aug 3, 2022 RX Yes Yes 9,758,524 ⤷  Start Trial ⤷  Start Trial
Astrazeneca LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes 8,877,255 ⤷  Start Trial Y ⤷  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 ASTRAZENECA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 6,936,590 ⤷  Start Trial
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 5,690,960 ⤷  Start Trial
Astrazeneca DALIRESP roflumilast TABLET;ORAL 022522-002 Jan 23, 2018 9,468,598 ⤷  Start Trial
Astrazeneca LEXXEL enalapril maleate; felodipine TABLET, EXTENDED RELEASE;ORAL 020668-002 Oct 28, 1998 4,374,829 ⤷  Start Trial
>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 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
➤ 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

Supplementary Protection Certificates for ASTRAZENECA Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 SPC/GB13/021 United Kingdom ⤷  Start Trial PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
1506211 CR 2014 00037 Denmark ⤷  Start Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2203431 15C0013 France ⤷  Start Trial PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
1506211 132014902277722 Italy ⤷  Start Trial PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

AstraZeneca: Market Position, Strengths & Strategic Insights

Last updated: February 26, 2026

What is AstraZeneca’s current market position in the pharmaceutical industry?

AstraZeneca ranks among the top ten global pharmaceutical companies by revenue. In 2022, it achieved approximately $44 billion in sales, with major contributions from oncology (especially lung and breast cancer therapies), cardiovascular, renal, and metabolic diseases. The company holds leading positions in several therapeutic segments, notably in oncology, with a 13% global market share in this area, second only to Roche. Its geographic footprint extends globally, with the United States contributing roughly 44% of revenue, followed by Europe, Asia, and other regions.

What are AstraZeneca’s core strengths?

Portfolio Diversification

AstraZeneca’s portfolio spans multiple high-growth therapeutic areas. Its oncology segment, driven by blockbuster drugs like Tagrisso, Imfinzi, and Lynparza, accounts for nearly 50% of total sales. The company maintains a strong pipeline with over 80 projects progressing through clinical phases, emphasizing innovation in immuno-oncology, targeted therapies, and respiratory diseases.

R&D Investment

The company allocates approximately 20% of revenues to R&D, enabling continuous pipeline expansion. This level of investment exceeds industry averages and supports sustained innovation. Its R&D centers are located in key markets, including the UK, US, and Sweden.

Strategic Collaborations and Licensing

AstraZeneca has entered multiple partnerships, including co-development agreements with biotech firms and licensing deals with research institutes. These collaborations accelerate drug development and access to novel platforms such as antibody-drug conjugates and gene-based therapies.

Manufacturing Capabilities

The company has advanced manufacturing facilities globally, with significant capacity for biologics and small molecules. This supports reliable supply chains for commercial and clinical needs.

How does AstraZeneca compare with key competitors?

Company 2022 Revenue Major Focus Areas Pipeline Highlights Market Share (Oncology)
Pfizer $100B Vaccines, oncology, cardiovascular mRNA vaccines, cancer immunotherapies 8%
Roche $63B Oncology, diagnostics Cancer immunotherapies, companion diagnostics 17%
Novartis $51B Oncology, biosimilars, ophthalmology CAR-T therapies, biosimilars 9%
AstraZeneca $44B Oncology, CVRM, respiratory PARP inhibitors, targeted lung therapies 13%

AstraZeneca outperforms many competitors in certain oncology niches, notably in targeted lung cancer treatments. Its focus on precision medicine has created a competitive advantage, though it faces stiff competition from Roche’s comprehensive oncology portfolio.

What strategic initiatives shape AstraZeneca’s future?

Focus on Oncology and Rare Diseases

AstraZeneca plans to expand its oncology pipeline, emphasizing personalized medicine. It has prioritized expanding the use of its landmark drugs and developing next-generation therapies for difficult-to-treat cancers.

Investment in Digital and Precision Medicine

The company is integrating digital health tools into clinical development and patient management. It collaborates with tech firms for data analytics, AI-driven drug discovery, and digital therapeutics.

Geographic Expansion

AstraZeneca is increasing market penetration in emerging markets, especially China and India, through tailored pricing strategies and local partnerships. It aims to roughly double revenues from emerging markets by 2025.

Sustainable Innovation and Pricing Strategies

AstraZeneca aligns its R&D and business models with sustainability initiatives, including responsible pricing and access programs to expand drug availability in lower-income regions.

What are the main risks and challenges?

  • Patent expirations threaten revenue streams in mature segments.
  • Competitive pressures intensify, especially from biologics and biosimilars.
  • Regulatory challenges in novel therapies may delay market entry.
  • Political and pricing pressures in key markets could affect profitability.

Closing Summary

AstraZeneca maintains strong positioning through diversification, a focused oncology pipeline, and strategic collaborations. Its aggressive R&D investment and expansion into emerging markets support growth despite competitive and regulatory risks.

Key Takeaways

  • AstraZeneca is a top-10 global pharma company with a $44 billion revenue in 2022.
  • Its oncology segment dominates, with a 13% market share and a pipeline of over 80 projects.
  • The company’s strengths include diversified product lines, high R&D spending, strategic alliances, and manufacturing capacity.
  • Competition from Roche, Pfizer, and Novartis remains intense, especially on innovative biologics.
  • Future growth hinges on expanding oncology and rare disease portfolios, digital health integration, and geographic expansion in emerging markets.

Frequently Asked Questions

  1. How does AstraZeneca’s pipeline compare to its competitors?

    • The company has over 80 projects in clinical stages, with significant investments in immuno-oncology, targeted therapies, and genetics-based treatments, positioning it strongly amid industry leaders.
  2. What are the key drugs driving AstraZeneca’s current revenue?

    • Tagrisso, Imfinzi, Lynparza, and Farxiga are the main contributors, especially in oncology and cardiovascular/renal areas.
  3. How is AstraZeneca addressing patent cliff risks?

    • Through pipeline expansion, lifecycle management of existing drugs, and diversification into rare diseases.
  4. What geographies are critical for AstraZeneca’s growth?

    • The US remains dominant, but China and India are strategic for expansion, representing high-growth markets with localized strategies.
  5. How does AstraZeneca invest in digital health?

    • It collaborates with tech companies to improve clinical trial efficiency, patient monitoring, and real-world data utilization, integrating AI and data analytics into its research processes.

References

[1] AstraZeneca Annual Report 2022. (2022). AstraZeneca.
[2] IQVIA. (2022). Top 20 Global Pharma Companies.
[3] Evaluate Pharma. (2022). World Preview 2022.
[4] Ross, J., & Zhang, Y. (2022). Competitive dynamics in global oncology. Pharma Intelligence.

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