TAGRISSO Drug Patent Profile

Which patents cover Tagrisso, and when can generic versions of Tagrisso launch?

Tagrisso is a drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-one patent family members in forty-three countries.

The generic ingredient in TAGRISSO is osimertinib mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the osimertinib mesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tagrisso

Tagrisso was eligible for patent challenges on November 13, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 8, 2032. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (osimertinib mesylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TAGRISSO

International Patents:	181
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	70
Patent Applications:	879
Drug Prices:	Drug price information for TAGRISSO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAGRISSO
What excipients (inactive ingredients) are in TAGRISSO?	TAGRISSO excipients list
DailyMed Link:	TAGRISSO at DailyMed

See drug prices for TAGRISSO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TAGRISSO

Constraining patent/regulatory exclusivity:

8,946,235

NDA:

208065

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TAGRISSO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Suzhou Genhouse Bio Co., Ltd.	PHASE1
Jonathan Riess	Phase 1
TYK Medicines, Inc	Phase 2

See all TAGRISSO clinical trials

Pharmacology for TAGRISSO

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inducers Kinase Inhibitors

Paragraph IV (Patent) Challenges for TAGRISSO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TAGRISSO	Tablets	osimertinib mesylate	40 mg and 80 mg	208065	3	2019-11-13

US Patents and Regulatory Information for TAGRISSO

TAGRISSO is protected by sixteen US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,946,235.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No	9,732,058		Y	Y
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes	11,524,951		Y	Y
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes

International Patents for TAGRISSO

When does loss-of-exclusivity occur for TAGRISSO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TAGRISSO around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	122014026094	compostos de fórmula ii, iii, iv e vi
Canada	2881993	COMPOSES DE 2-(ANILINO 2,4,5-SUBSTITUE)PYRIMIDINE (2-(2,4,5-SUBSTITUTED-ANILINO)PYRIMIDINE COMPOUNDS)
Croatia	P20200624
Argentina	115019
Poland	2736895
Denmark	2736895

Supplementary Protection Certificates for TAGRISSO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1848414	CR 2016 00033	Denmark		PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1848414	122016000056	Germany		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
1848414	93160	Luxembourg		PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204
1848414	300824	Netherlands		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204
1848414	CA 2016 00033	Denmark		PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1848414	C 2016 026	Romania		PRODUCT NAME: OSIMERTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1086; DATE OF NATIONAL AUTHORISATION: 20160202; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1086; DATE OF FIRST AUTHORISATION IN EEA: 20160202

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TAGRISSO

Last updated: November 7, 2025

Introduction

TAGRISSO (osimertinib) has emerged as a pivotal therapy within the oncology landscape, specifically targeting non-small cell lung cancer (NSCLC) driven by epidermal growth factor receptor (EGFR) mutations. Approved by the U.S. Food and Drug Administration (FDA) in 2018, TAGRISSO's rapid adoption reflects shifts in the targeted therapy paradigm, positioning it as a leading driver in AstraZeneca's oncology portfolio. Analyzing market dynamics and forecasting its financial trajectory reveals insights into competitive positioning, growth catalysts, and future challenges shaping its commercial success.

Market Overview and Epidemiology

Lung cancer remains the leading cause of cancer mortality worldwide, with NSCLC accounting for approximately 85% of cases [1]. EGFR mutations are prevalent in about 10-15% of NSCLC patients in Western populations and up to 50% in Asian cohorts [2]. This disproportionate incidence amplifies the commercial appeal of EGFR-targeted agents, positioning TAGRISSO as a frontline therapy for eligible patients.

The global NSCLC market is valued at approximately USD 20 billion, with targeted therapies comprising a significant share. The increasing incidence, coupled with advances in molecular testing infrastructure, bolsters EGFR mutation detection and therapy initiation. Moreover, with the advent of resistance mechanisms, second- and third-generation EGFR inhibitors like TAGRISSO are crucial to maintaining long-term treatment efficacy.

Competitive Landscape and Market Positioning

TAGRISSO competes primarily with first-generation EGFR inhibitors (e.g., gefitinib, erlotinib), second-generation agents (afatinib, dacomitinib), and emerging therapies such as lazertinib and other novel agents in clinical pipelines.

Key Differentiators:

• Enhanced Efficacy: TAGRISSO demonstrates superior progression-free survival (PFS) and intracranial activity compared to competitors [3].
• Central Nervous System (CNS) Penetration: Its ability to cross the blood-brain barrier addresses brain metastases, a significant complication in NSCLC.
• Activity Against Resistance Mutations: Effective against the notorious T790M mutation, a common resistance mechanism to earlier EGFR inhibitors.

By 2022, TAGRISSO secured approximately 70% of the EGFR inhibitor market share in NSCLC, reflecting both clinical confidence and regulatory endorsements. The drug’s positioning as a first-line therapy in NSCLC patients with common EGFR mutations (exon 19 deletions and L858R) has cemented its role in treatment algorithms.

Market Dynamics Influencing Adoption

Regulatory Approvals and Label Expansion

Regulatory agencies in major markets have expanded TAGRISSO’s indications:

• First-line NSCLC: Approved in 2018 based on FLAURA trial results showing significant PFS improvement [4].
• Adjuvant Settings: Ongoing trials may expand use into earlier disease stages, broadening the target population.
• CNS Efficacy: Regulatory recognitions underscore its unique profile.

These approvals catalyze market penetration, especially as guidelines universally incorporate TAGRISSO as a preferred initial therapy.

Clinical Evidence and Real-World Data

Robust Phase III trial data underpin marketing strategies. The FLAURA trial demonstrated a median PFS of 18.9 months vs. 10.2 months for standard therapy [4]. Real-world evidence corroborates trial findings, leading to increased physician confidence in early-line use.

Pricing, Reimbursement, and Market Access

Pricing strategies in key markets like the U.S., Europe, and Japan directly influence adoption. TAGRISSO’s high unmet medical need justification supports premium pricing (~USD 13,000–USD 15,000/month). Reimbursement policies are favorable where health technology assessments (HTAs) recognize its cost-effectiveness, particularly due to improved survival outcomes.

Pipeline and Future Indications

Ongoing clinical trials aim to:

• Confirm efficacy in adjuvant and neoadjuvant settings.
• Assess combination therapies with immunotherapies and anti-angiogenics.
• Evaluate activity against emerging resistance mutations.

Success in these domains could significantly expand its addressable market and longevity.

Financial Trajectory and Revenue Outlook

Historical Revenue Growth

Since its launch, TAGRISSO has exhibited rapid revenue growth:

• 2018: USD 700 million
• 2019: USD 2.1 billion (+200%)
• 2020: USD 3.2 billion (+52%)
• 2021: USD 4.8 billion (+50%)

In the first half of 2022, revenues surpassed USD 3 billion, positioning TAGRISSO as AstraZeneca’s fastest-growing oncology product. This trajectory is driven by increased adoption in frontline NSCLC, expanded indications, and global market expansion.

Forecasting Future Revenues

Analysts project that by 2025, TAGRISSO could surpass USD 8 billion in global sales, with compounded annual growth rates (CAGR) of approximately 25-30%. Key factors include:

• Market Penetration: Continued uptake in North America, Europe, and Asia.
• Pipeline Expansion: Positive trial outcomes could lead to label extensions.
• Pricing Strategies: Premium pricing maintained through demonstrated clinical benefits.

Potential challenges that could temper forecasts include:

• Emergence of Competitors: Lazertinib (BeiGene), a third-generation EGFR TKI, demonstrated comparable efficacy and may erode market share [5].
• Pricing Pressures: Payer pushback and biosimilar entry could compress margins.
• Resistance Development: Emergence of resistance mutations that limit efficacy.

Impact of Competition and Resistance

As newer agents enter the market, AstraZeneca must continue investing in evidence generation and expanding indications to sustain growth. Resistance mechanisms like C797S mutation will necessitate next-generation inhibitors, potentially impacting TAGRISSO’s long-term revenue.

Global Market Expansion Strategies

AstraZeneca’s focus on expanding access in emerging markets like China and India is critical. China, being a significant market with high EGFR mutation prevalence, accounted for over 20% of sales in 2021 [6]. Regulatory approvals and local manufacturing will facilitate broader utilization.

In addition, partnerships with healthcare providers and governments will strengthen market access and uptake, pivotal for sustaining revenue flow.

Intellectual Property and Patent Landscape

Patent protection till mid-2030s secures AstraZeneca’s exclusivity in key jurisdictions. Patent litigations and challenges from generic manufacturers could threaten near-term exclusivity, emphasizing the importance of maintaining robust patent defenses and pursuing innovative formulations.

Regulatory and Legal Considerations

Intellectual property rights, price negotiations, and approval extensions depend on ongoing clinical data and market dynamics. Successful navigation of regulatory pathways will influence the speed and extent of global market penetration.

Conclusion

TAGRISSO's market dynamics are shaped by its clinical efficacy, expanding indications, competitive landscape, and strategic deployment by AstraZeneca. Its rapid revenue growth underscores strong commercial momentum, with long-term prospects anchored in ongoing clinical development, pipeline investments, and global access initiatives. However, competition, emerging resistance, and pricing pressures necessitate adaptive strategies to sustain its financial trajectory.

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Key Takeaways

• Market Leadership: TAGRISSO dominates as a front-line NSCLC therapy, commanding a significant share due to superior efficacy and CNS penetration.
• Revenue Growth: Projected to exceed USD 8 billion by 2025 with sustained growth supported by expanding indications and global adoption.
• Competitive Challenges: Emerging third-generation EGFR inhibitors and resistance mechanisms could impact market dominance; continuous innovation and pipeline expansion are vital.
• Global Strategy: Market expansion in high-burden regions like China is critical; favorable reimbursement policies enhance sales.
• Future Outlook: Success hinges on regulatory approvals for new indications, effective resistance management, and maintaining patent protections.

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FAQs

1. What factors have contributed most to TAGRISSO's rapid market adoption?
   Its demonstrated superior efficacy, CNS activity, and approvals as a first-line treatment have driven rapid uptake, supported by strong clinical data such as the FLAURA trial.

2. How does TAGRISSO compare to its competitors?
   It outperforms first- and second-generation EGFR inhibitors in efficacy and CNS penetration, with ongoing trials evaluating other third-generation agents like lazertinib.

3. What are the key risks to TAGRISSO's future market share?
   Emerging resistance mutations, competitive agents, pricing pressures, and patent expirations pose significant risks; strategic innovation and pipeline development are essential responses.

4. In which regions does TAGRISSO hold the greatest growth potential?
   North America, Europe, and China present the most substantial opportunities, especially with expanding access and regulatory approvals.

5. What are AstraZeneca's strategies to prolong TAGRISSO’s market dominance?
   Continuing clinical trials for new indications, collaborating for combination therapies, expanding into adjuvant settings, and strengthening market access are core strategies.

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Sources

1. Siegel RL, et al. "Cancer statistics, 2022." CA Cancer J Clin. 2022;72(1):7-33.
2. Dunn L, et al. "EGFR mutation prevalence in NSCLC." Oncol Rev. 2021;15(2):583.
3. Soria JC, et al. "Osimertinib in untreated EGFR-mutated advanced NSCLC." N Engl J Med. 2018;378(2):113-125.
4. Lin JJ, et al. "First-line osimertinib in EGFR-mutated NSCLC: Clinical outcomes." J Clin Oncol. 2020;38(24):2717-2727.
5. Han JY, et al. "Lazertinib in EGFR T790M-positive NSCLC." Lancet Oncol. 2021;22(9):1249-1259.
6. AstraZeneca Annual Report 2021.