ASTRAZENECA AB Company Profile

What is the competitive landscape for ASTRAZENECA AB

ASTRAZENECA AB has twelve approved drugs.

There are thirty-nine US patents protecting ASTRAZENECA AB drugs. There is one tentative approval on ASTRAZENECA AB drugs.

There are nine hundred and thirty patent family members on ASTRAZENECA AB drugs in fifty-four countries and one hundred and forty-three supplementary protection certificates in nineteen countries.

Summary for ASTRAZENECA AB

International Patents:	930
US Patents:	39
Tradenames:	13
Ingredients:	10
NDAs:	12
Drug Master File Entries:	2
Patent Litigation for ASTRAZENECA AB:	See patent lawsuits for ASTRAZENECA AB
PTAB Cases with ASTRAZENECA AB as patent owner:	See PTAB cases with ASTRAZENECA AB as patent owner

Drugs and US Patents for ASTRAZENECA AB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010		DISCN	Yes	No	8,628,799		Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010		DISCN	Yes	No	8,628,799		Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	8,906,851*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes	9,616,028*PED				Y
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	8,431,685*PED				Y

Expired US Patents for ASTRAZENECA AB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005	6,872,700
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-002	Sep 25, 2007	7,271,238
Astrazeneca Ab	ONGLYZA	saxagliptin hydrochloride	TABLET;ORAL	022350-001	Jul 31, 2009	RE44186
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	6,902,744
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010	6,395,767
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	7,741,269
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017	9,198,925

Paragraph IV (Patent) Challenges for ASTRAZENECA AB drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg		2013-07-31
	Tablets	2.5 mg and 5 mg		2013-07-31
	Injection	250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe		2014-06-11
	HydrochlorideExtended-release Tablets	2.5 mg/1000 mg		2018-10-29

International Patents for ASTRAZENECA AB Drugs

Country	Patent Number	Estimated Expiration
Taiwan	201406743
Israel	282665
World Intellectual Property Organization (WIPO)	2019074799
Israel	273713
Russian Federation	2015151200
Russian Federation	2011154148
Taiwan	I707700

Supplementary Protection Certificates for ASTRAZENECA AB Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C01506211/01	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
1506211	300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
2435025	2019026	Norway		PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435024	PA2021511	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1506211	CR 2014 00037	Denmark		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

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Astral
• Astrazeneca
• Astrazeneca Ab
• Astrazeneca Lp

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

Last updated: October 15, 2025

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Introduction

AstraZeneca AB stands as a premier multinational pharmaceutical enterprise, renowned for its innovative medicine portfolio spanning oncology, cardiovascular, respiratory, and immunology segments. Positioned at the intersection of cutting-edge drug development and market expansion, AstraZeneca has cultivated a formidable presence within the global pharmaceutical industry. This analysis explores AstraZeneca’s current market standing, core strengths, competitive positioning, and strategic outlook, providing stakeholders with actionable insights to inform investment and partnership decisions.

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Market Position of AstraZeneca AB

Global Footprint and Revenue Profile

With operations spanning over 100 countries, AstraZeneca reported global revenues of approximately USD 44.5 billion in 2022, underscoring sustained growth amid a competitive landscape[1]. Its strategic emphasis on innovation-driven therapeutics positions it advantageously against peers like Pfizer, Novartis, and Roche. The company’s strong presence in North America, Europe, and emerging markets such as Asia-Pacific supports diversified revenue streams, insulating it from regional market volatilities.

Therapeutic Focus and Product Leadership

AstraZeneca’s core therapeutic areas—oncology, respiratory, cardiovascular, and rare diseases—align with high-growth, unmet medical needs. Its flagship products include Tagrisso (osimertinib) in lung cancer, Imfinzi (durvalumab) in immuno-oncology, and Farxiga (dapagliflozin) in diabetes and heart failure. The company’s portfolio exhibits a high R&D-to-revenue ratio, emphasizing its innovation pipeline[2]. Notably, AstraZeneca’s oncology segment contributed over 50% of revenues in 2022, illustrating its market dominance in this domain.

Pipeline and R&D Strategy

AstraZeneca invests approximately USD 6 billion annually into R&D, reflecting its prioritization of pipeline development. The company’s strategic focus on biologics, targeted therapies, and personalized medicine aligns with future industry trends[3]. Recent approvals and clinical trial successes, such as Enhertu (trastuzumab deruxtecan) in breast cancer, advance its competitive positioning.

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Strengths and Competitive Advantages

Innovative R&D Infrastructure

AstraZeneca’s robust R&D capabilities underpin its pipeline of over 100 active compounds, many in late-stage development. The company's strategic alliances, including collaborations with Amgen, Merck, and Daiichi Sankyo, enable access to novel platforms and accelerate drug discovery.

Diversified and High-Value Portfolio

The diversification across multiple therapeutic areas buffers AstraZeneca against market-specific downturns. Its leadership in lung cancer, through Tagrisso and Lynparza (olaparib), secures long-term revenue streams and maintains high-margin operations.

Regulatory and Market Access

AstraZeneca’s established regulatory expertise facilitates swift approvals in key markets. Its proactive engagement with health authorities resulted in accelerated approvals for critical COVID-19 therapies and vaccines, exemplified by its collaboration with Oxford-AstraZeneca in COVID-19 vaccine development.

Emerging Market Penetration

Growth in emerging markets like China, Brazil, and India is strategic for AstraZeneca. Local manufacturing, tailored marketing strategies, and partnerships with regional healthcare providers enhance its market share and expand patient access.

Sustainability and Corporate Responsibility

AstraZeneca’s commitment to environmental sustainability and equitable healthcare strengthens its corporate reputation, fostering stakeholder trust and long-term shareholder value.

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Strategic Insights and Competitive Dynamics

Market Challenges and Risks

Despite its strengths, AstraZeneca faces challenges including patent expirations (patents for key products like Brilinta and Crestor), intense price competition, and pipeline attrition risks. The global push towards biosimilars threatens to erode revenues from biologic therapies.

Digital Transformation and Data-Driven Innovation

AstraZeneca invests heavily in digital health, data analytics, and AI-driven drug discovery. These initiatives promise to reduce development timelines and improve personalized treatment efficacy, creating a competitive moat.

Strategic Focus on Rare Diseases and Immuno-Oncology

The company’s aggressive expansion into rare diseases and immuno-oncology bolsters its leadership position. The successful commercialization of personalized therapies, exemplified by Enhertu, positions AstraZeneca at the forefront of precision medicine.

Collaborative Ecosystems and Alliances

Strategic alliances expand pipeline breadth, offset R&D costs, and enable market access. Collaborations with biotech firms and academic institutions foster innovation, facilitating early-stage discovery and accelerated product approval.

Market Expansion and M&A Strategy

AstraZeneca’s acquisition strategy targets innovative pipeline assets, as evidenced by its 2019 acquisition of Alexion Pharmaceuticals for USD 39 billion. These acquisitions diversify revenue streams and enhance capabilities in high-growth segments like rare diseases.

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Conclusion

AstraZeneca’s formidable market position derives from its innovative pipeline, diversified product portfolio, and strategic expansion into emerging markets. Its focus on personalized medicine, digital innovation, and strategic collaborations underpin its competitive edge. While patent expirations and biosimilar threats pose risks, AstraZeneca's ongoing R&D investments and strategic M&A activity ensure resilience and future growth potential.

Stakeholders should monitor AstraZeneca’s pipeline progress, regulatory milestones, and partnership developments to gauge its evolving competitive landscape. Its commitment to innovation and strategic agility positions AstraZeneca as a resilient market leader in the global pharmaceutical industry.

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Key Takeaways

• AstraZeneca maintains a leading position in oncology and immunology, driven by high-revenue blockbuster drugs and a robust pipeline.
• The company’s diversified portfolio and emerging market expansion strategies mitigate regional and therapeutic risks.
• Strategic collaborations and acquisitions fuel innovation and market penetration, particularly in rare diseases and personalized medicine.
• Digital health investments and AI capabilities are central to AstraZeneca’s future R&D and growth strategies.
• Continual patent management and pipeline development are critical to counter biosimilar competition and sustain long-term growth.

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FAQs

1. How does AstraZeneca differentiate itself from competitors like Pfizer and Novartis?
AstraZeneca emphasizes targeted therapies and personalized medicine, backed by a strong pipeline in oncology and immunology, complemented by strategic collaborations and digital innovations, setting it apart in innovation-driven growth.

2. What are the key growth markets for AstraZeneca?
Emerging markets such as China, India, and Latin America are prioritized due to demographic shifts, increasing healthcare access, and local manufacturing advantages.

3. How does AstraZeneca approach pipeline development amid patent expiry risks?
The company invests heavily in R&D, partners with biotech firms, and targets high-growth areas like immuno-oncology and rare diseases to offset revenue losses from patent expirations.

4. What is AstraZeneca’s strategic focus post-2022?
Focus areas include expanding its presence in immuno-oncology, advancing personalized medicine, digital health integration, and further acquisitions to bolster its pipeline in high-need therapeutic areas.

5. How significant are collaborations in AstraZeneca’s growth?
Strategic partnerships are vital, providing access to innovative technologies, shared R&D costs, and accelerated product development, reinforcing AstraZeneca’s competitive advantages.

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References

1. AstraZeneca Annual Report 2022.
2. [Pharmaceutical Executive, 2022] — AstraZeneca’s R&D Investment Analysis.
3. Bloomberg Intelligence, 2022 — Industry Trends & AstraZeneca Pipeline Insights.