TAGRISSO Drug Patent Profile

When do Tagrisso patents expire, and when can generic versions of Tagrisso launch?

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

This drug has one hundred and ninety-three patent family members in forty-four 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:	193
US Patents:	5
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

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 seventeen US patents and three FDA Regulatory Exclusivities.

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			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	208065-001	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
Canada	3133766	OSIMERTINIB DESTINE A ETRE UTILISE DANS LE TRAITEMENT DU CANCER DU POUMON NON A PETITES CELLULES (OSIMERTINIB FOR USE IN THE TREATMENT OF NON-SMALL CELL LUNG CANCER)
Argentina	087336
San Marino	T202100330
Brazil	122014026114
Canada	2881993	COMPOSES DE 2-(ANILINO 2,4,5-SUBSTITUE)PYRIMIDINE (2-(2,4,5-SUBSTITUTED-ANILINO)PYRIMIDINE COMPOUNDS)

Supplementary Protection Certificates for TAGRISSO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1848414	CA 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	132016000078445	Italy		PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 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
1848414	300824	Netherlands		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204

Market Dynamics and Financial Trajectory for TAGRISSO

Last updated: March 17, 2026

What Is TAGRISSO and Its Market Position?

TAGRISSO (osimertinib) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Approved by the FDA in 2015 for treating metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations, it has become a cornerstone therapy within this niche.

As of 2022, its market share among EGFR-mutant NSCLC treatments exceeds 50%. Its approval also spans multiple regions, including the EU, Japan, and China.

How Has the Market for EGFR Inhibitors Evolved?

The global NSCLC therapeutic market stood at USD 17.3 billion in 2022, with targeted therapies accounting for nearly 60%. EGFR inhibitors represent a significant segment, driven by:

• Growing prevalence of EGFR-mutant NSCLC.
• Advances in molecular diagnostics.
• Regulatory approvals expanding indications.

Competitive drugs include:

• Erlotinib (Tarceva)
• Gefitinib (Iressa)
• Afatinib (Gilotrif)
• Dacomitinib (Vizimpil)

TAGRISSO dominates emerging as the first-line standard of care for patients with EGFR T790M mutation-positive NSCLC.

What Are the Revenue Trends and Key Sales Figures?

Takeda Pharmaceutical's revenue report for 2022 indicates:

Year	Global Sales (USD millions)	Share of Total Oncology Revenue
2019	$445	10%
2020	$785	15%
2021	$1,650	19%
2022	$2,100	22%

The revenue growth rate from 2019 to 2022 averages approximately 78% annually, driven by expanding indications and geographic penetration, especially in China.

How Do Patent and Patent Expiry Dynamics Impact Market?

Takeda's patent for TAGRISSO is valid until 2028 in the US and Europe. Patent cliffs could incentivize biosimilar or generic entrants post-2028, potentially reducing prices and market share.

What Are Future Growth Projections?

Analysts project that TAGRISSO's revenue will reach USD 3.2 billion by 2025, assuming:

• Continued approval for first-line treatment in EGFR-mutant NSCLC.
• Expansion into earlier disease stages.
• Efficacy in combination therapies.

Global penetration, especially in emerging markets like China, supports higher growth, with market share expected to increase from 55% in 2022 to over 65% in 2025.

Which Clinical Pipeline Developments Influence Financial Trajectory?

Takeda actively explores TAGRISSO in:

• Combination with immunotherapies (e.g., PD-1 inhibitors).
• Adjuvant settings.
• Use in other solid tumors with EGFR mutations, such as glioblastoma.

Early-phase data suggest potential for enhanced efficacy, which could extend lucrative indications beyond current sales.

What Are Regulatory and Market Risks?

Key risks include:

• Patent expiration in major markets.
• Competition from emerging targeted therapies.
• Regulatory delays in new indications.
• Pricing pressures in value-based healthcare systems.

Market access challenges in countries with price controls, notably China and parts of Europe, may limit revenue potential.

How Do Competitive Dynamics and R&D Invests Affect Outlook?

Takeda's R&D budget for oncology approximated USD 1.2 billion in 2022, emphasizing pipeline expansion. Competition with AstraZeneca's Tagrisso biosimilar developments and local players like China’s Fosun increases the complexity.

Key Takeaways

• TAGRISSO leads the EGFR inhibitor market for NSCLC, with rapid growth driven by new approvals and regional expansion.
• Revenue growth expects to continue, reaching over USD 3 billion by 2025.
• Patent expiry in 2028 poses significant risks, prompting investment in pipeline expansion and combination therapies.
• Competition and pricing pressures remain significant risks.
• Market dynamics favor Takeda's strategic focus on expanding indications and geographic reach.

FAQs

1. When does TAGRISSO go off patent in the US?
2028 is the estimated patent expiry in the United States.

2. What is the primary market for TAGRISSO?
The US, China, and Japan constitute the largest markets, with significant growth potential in Europe and emerging economies.

3. Are there approved combination therapies involving TAGRISSO?
Yes. Trials combining TAGRISSO with PD-1 inhibitors or other agents are ongoing, with promising early results.

4. How is competition affecting TAGRISSO's market leadership?
Biosimilars and generics post-2028 could erode market share, but proprietary combination regimens and new indications may offset losses temporarily.

5. What factors are likely to influence future sales growth?
Regulatory approvals for new indications, geographic expansion, biosimilar competition, and pipeline developments are key drivers.

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References

[1] Takeda Pharmaceutical Company Annual Reports, 2019-2022.
[2] GlobalData, NSCLC Therapy Market Report, 2022.
[3] U.S. Food and Drug Administration (FDA) approvals, 2015-2022.
[4] European Medicines Agency (EMA) clinical data, 2023.
[5] Citi Research, Oncology Market Forecasts, 2022.