Astrazeneca Company Profile

What is the competitive landscape for ASTRAZENECA

ASTRAZENECA has ninety-two approved drugs.

There are one hundred and five US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.

There are two thousand and seventy-nine patent family members on ASTRAZENECA drugs in sixty-eight countries and three hundred and eighty supplementary protection certificates in twenty countries.

Summary for Astrazeneca

International Patents:	2079
US Patents:	105
Tradenames:	64
Ingredients:	60
NDAs:	92
Patent Litigation for Astrazeneca:	See patent lawsuits for Astrazeneca
PTAB Cases with Astrazeneca as patent owner:	See PTAB cases with Astrazeneca as patent owner

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	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	8,721,615*PED				Y
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005		DISCN	Yes	No
Astrazeneca	TENORMIN	atenolol	INJECTABLE;INJECTION	019058-001	Sep 13, 1989		DISCN	Yes	No
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes	8,685,934*PED				Y
Astrazeneca	AQUASOL A	vitamin a	CAPSULE;ORAL	083080-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005		DISCN	Yes	No

Expired US Patents for Astrazeneca

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010	8,628,799
Astrazeneca	YUTOPAR	ritodrine hydrochloride	TABLET;ORAL	018555-001	Approved Prior to Jan 1, 1982	3,410,944
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	RE44186
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-002	Sep 17, 2001	5,466,699*PED
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	7,563,871
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522-001	Feb 28, 2011	8,618,142

Paragraph IV (Patent) Challenges for ASTRAZENECA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	50 mg/mL, 2.5 mL and 5 mL syringe		2009-10-01
	Inhalation Suspension	1 mg/2 mL		2010-05-28
	Delayed-release Tablets	20 mg		2012-03-30
	Tablets	60 mg		2015-09-30
	Tablets	500 mcg		2015-03-02
	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
	Delayed-release	20 mg and 40 mg		2005-08-05
	For Injection	20 mg/vial and 40 mg/vial		2009-11-23
	Inhalation Suspension	0.25 mg/2 mL and 0.5 mg/2 mL		2005-09-15
	Delayed-release Capsules	20 mg		2007-03-19
	Tablets	90 mg		2015-07-20
	Tablets	5 mg, 10 mg, 20 mg and 40 mg		2007-08-13
	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
	Nasal Spray	0.032 mg (32 mcg)/spray		2007-05-14
	Delayed-release for Oral Suspension	2.5 mg and 5 mg		2018-09-24

International Patents for Astrazeneca Drugs

Country	Patent Number	Estimated Expiration
Spain	2914854
Japan	2017222706
Canada	2929956
Spain	2774367
Germany	69940171
Israel	274066

Supplementary Protection Certificates for Astrazeneca Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	2010C/008	Belgium		PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
2201012	C20240039	Finland
3347352	LUC00292	Luxembourg		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/22/1671 20220819
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
2673237	PA2019010,C2673237	Lithuania		PRODUCT NAME: CIRKONIO CIKLOSILIKATO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/17/1173/001-004 20180322

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 – Market Position, Strengths & Strategic Insights

Last updated: December 27, 2025

Executive Summary

AstraZeneca stands as one of the world’s leading biopharmaceutical companies, with a diversified portfolio spanning oncology, cardiovascular, respiratory, and metabolic diseases. This report provides a comprehensive assessment of AstraZeneca’s market position, competitive strengths, strategic initiatives, and future outlook within the evolving pharmaceutical landscape. By analyzing its core competencies, pipeline prospects, market challenges, and strategic investments, stakeholders can better understand AstraZeneca’s trajectory amid intensifying global competition, regulatory shifts, and innovation demands.

---

Market Position Overview

Global Footprint & Financial Metrics

Attribute	2022 Data	Notes
Revenue	~$37.2 billion	Up 15% YoY, driven by oncology & R&D advancements
Revenue Segments	Oncology (44%), CVRM (21%), Respiratory/Other (35%)	Reflects strategic focus shift
Market Capitalization	~$174 billion (as of Dec 2022)	Ranking among top 20 pharmaceutical firms globally
Top Markets	US (45%), Europe (30%), ROW (25%)	US remains primary revenue driver

Market Share in Key Therapeutic Areas

Therapeutic Area	Global Market Share (Approximate)	Key Competitors
Oncology	8-10%	Roche, Novartis, Pfizer
Cardiovascular (CVRM)	4-6%	Novartis, Pfizer
Respiratory & Allergies	3-4%	GlaxoSmithKline, Sanofi

Key Market Highlights

• Positioning in Oncology: AstraZeneca’s focus on targeted therapies like Tagrisso, Imfinzi, and Lynparza has cemented its leadership in the oncology segment.
• Therapeutic Diversification: Reduced reliance on legacy drugs, shifting toward personalized medicine.
• Emerging Market Expansion: Focused investments in Asia, Latin America, and Africa, accounting for 30% of recent revenue growth.

---

Strengths & Core Competencies

Innovative R&D Portfolio

• Pipeline Strength: Over 80 candidates in clinical development, with 15 in Phase III as of late 2022.

• Breakthrough Products:	Product	Indication	Approval Year	Market Impact
  Tagrisso (Osimertinib)	NSCLC (Non-small cell lung cancer)	2015	~$4.5 billion annual sales
  Imfinzi (Durvalumab)	Lung and bladder cancers	2017	Significant growth in immuno-oncology
  Lynparza (Olaparib)	Ovarian, breast, pancreatic cancers	2014	Pioneering PARP inhibitor market

Strategic Alliances & acquisitions

• Acquisition of Alexion (2021): Strengthened the rare diseases portfolio, particularly complement and hematology areas.
• Partnerships: Collaborations with Moderna, Samsung Biologics, and other biotech firms foster innovation and expand manufacturing capabilities.

Operational Excellence & Geographic Reach

• Manufacturing: Global network in 20+ countries ensures supply chain resilience.
• Digital Transformation: Investment in AI-driven R&D, real-world evidence, and personalized medicine.

---

Strategic Insights & Competitive Challenges

Key Opportunities

Area	Strategic Action	Potential Impact
Expansion in Oncology	Launch of novel immunotherapies and targeted agents	Market share growth; optimizing pipeline assets
Personalized Medicine & Biomarker Development	Investment in companion diagnostics and real-world data analytics	Enhanced treatment efficacy and market differentiation
Emerging Markets	Tailored pricing strategies, local partnerships	Revenue diversification, access expansion
Beyond Oncology (New Modalities)	Explore cell & gene therapies, mRNA platforms	Future pipeline diversification

Challenges & Risks

Risk Factor	Impact	Mitigation Strategy
Patent Expirations	Loss of exclusivity for blockbuster drugs	Diversify pipeline, accelerate novel product development
Regulatory & Pricing Pressures	Reduced profit margins	Proactive engagement with policymakers, value-based pricing
Intensified Competition	Market share erosion	Accelerate innovation, strategic acquisitions
Global Supply Chain Disruptions	Manufacturing delays	Diversify manufacturing bases, enhance supply chain robustness

---

Future Outlook & Strategic Recommendations

Forecasted Trends	Implications for AstraZeneca
Continued Oncology Growth	Focus on innovative immune-oncology, second-generation targeted therapies
Investments in mRNA & Cell Therapies	Early adoption, strategic partnerships to establish leadership positions
Emphasis on Digital & Precision Medicine	Leverage AI, real-world data, and biomarker developments to optimize R&D and commercialization
Sustainable & Responsible Business	ESG integration, ethical pricing, and global health initiatives to enhance brand reputation

Strategic Recommendations

• Accelerate clinical development in line with emerging tumor types.
• Expand strategic alliances in emerging markets for increased penetration.
• Enhance patient-centricity via digital engagement platforms.
• Invest in next-generation modalities such as mRNA, gene editing, and cell therapies.
• Strengthen patent portfolio and lifecycle management to mitigate patent cliff impact.

---

Competitive Landscape Comparison

Company	Market Focus	Key Therapies	R&D Investment (2022)	Market Cap (2022)	Notable Strategic Moves
AstraZeneca	Oncology, CV, Respiratory	Tagrisso, Imfinzi, Lynparza, Farxiga	~$6.3 billion	~$174 billion	Acquiring Alexion, mRNA partnerships
Roche	Oncology, Diagnostics	Herceptin, Avastin, Perjeta	~$10 billion	~$215 billion	Precision medicine, diagnostics
Pfizer	Vaccines, Oncology, Rare	Comirnaty, Xtandi, Ibrance	~$11.2 billion	~$204 billion	COVID-19 vaccine, acquisitions
Novartis	Oncology, Generics	Kymriah, Cosentyx	~$9 billion	~$196 billion	Cell therapies, biosimilars
GSK	Respiratory, Vaccines	Pulmozyme, Shingrix	~$4 billion	~$72 billion	Focus on vaccines, respiratory

---

Key Takeaways

• AstraZeneca’s strategic focus on oncology and targeted therapies has solidified its position in high-growth segments.
• Continued pipeline expansion and technological innovation are critical to maintaining competitive edge.
• Strategic acquisitions, especially in rare diseases and advanced modalities like mRNA, will diversify revenue streams.
• Emerging markets and personalized medicine remain vital for future growth.
• Navigating regulatory, patent, and pricing environments requires proactive and adaptive strategies.

---

FAQs

1. How does AstraZeneca differentiate itself from competitors like Roche and Pfizer?

AstraZeneca emphasizes targeted therapies and immuno-oncology with a focus on personalized medicine, supported by a more streamlined R&D pipeline and strategic acquisitions like Alexion. Its agile innovation approach and digital integration distinguish its competitive positioning.

2. What are AstraZeneca’s most promising pipeline candidates for the next 5 years?

Key pipeline candidates include Lung cancer therapies like Tagrisso and Imfinzi, ovarian cancer PARP inhibitors such as Lynparza, and emerging immunotherapies targeting solid tumors. Early-stage development in cell and gene therapies also holds potential.

3. How is AstraZeneca addressing patent expiries and biosimilar competition?

The company diversifies through pipeline growth, strategic M&A, and lifecycle management of existing products. It invests in next-generation therapies and diagnostics to sustain competitiveness.

4. What role do emerging markets play in AstraZeneca’s growth strategy?

Emerging markets account for approximately 30% of recent growth. The company adapts pricing models, local partnerships, and tailored product offerings to expand access and increase market share.

5. How is AstraZeneca leveraging digital technologies in its operations?

AstraZeneca invests in AI-driven drug discovery, real-world evidence collection, digital patient engagement, and supply chain automation to enhance efficiency, innovation, and patient outcomes.

---

References

1. AstraZeneca Annual Report 2022.
2. IQVIA Institute for Human Data Science. "The Global Oncology Market". 2022.
3. Statista. "Leading pharmaceutical companies by market cap 2022".
4. Pharmaceutical Executive. "Pipeline Innovations and Strategic M&A". 2022.
5. Company press releases and investor presentations, 2022-2023.

---

In conclusion, AstraZeneca maintains a robust market position driven by innovation, strategic acquisitions, and diversification, while navigating challenges through adaptive strategies focused on personalized medicine and emerging technology adoption.