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 five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in TAGRISSO is osimertinib mesylate. There is one drug master file entry 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 July 25, 2032. This may change due to patent challenges or generic licensing.

There have been eight 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

US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	70
Patent Applications:	985
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
Argentina	098989
Australia	2015204218
Canada	2933403
Chile	2016001609
China	105848647

Supplementary Protection Certificates for TAGRISSO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1848414	300824	Netherlands		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 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	CA 2016 00033	Denmark		PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1848414	132016000078445	Italy		PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204

Tagrisso Market Dynamics, Financial Trajectory, Patent Exclusivity, and Generic Risk

Last updated: September 26, 2026

Tagrisso, AstraZeneca’s osimertinib, is one of the company’s largest products and the leading targeted therapy for EGFR-mutated non-small-cell lung cancer. Its commercial profile is supported by first-line treatment, adjuvant therapy, unresectable stage III disease, broad international adoption, and combination-regimen expansion. AstraZeneca reported approximately $6.3 billion in Tagrisso sales in fiscal 2024, representing roughly 12% of company revenue. Core U.S. composition-of-matter protection is expected to extend into 2032, while formulation and method-of-use patents may create additional barriers. The principal long-term risk is small-molecule generic entry rather than biosimilar competition.

What is Tagrisso and which markets drive demand?

Tagrisso contains osimertinib mesylate, an oral, irreversible EGFR tyrosine kinase inhibitor. It selectively targets activating EGFR mutations and the T790M resistance mutation, with central nervous system penetration that supports treatment of brain metastases.

The principal commercial indications are:

Indication	Regulatory position	Commercial effect
First-line locally advanced or metastatic EGFR-mutated NSCLC	Established global indication	Largest revenue base
Adjuvant treatment after tumor resection	Approved in the U.S. and major markets	Expands use into earlier-stage disease
First-line osimertinib plus platinum-pemetrexed chemotherapy	FDA approved in 2024	Raises treatment intensity and duration
Unresectable stage III EGFR-mutated NSCLC after chemoradiotherapy	FDA approved in 2024 under the LAURA-based development program	Opens a new curative-intent segment
Previously treated EGFR T790M-positive NSCLC	Original commercial indication	Declining share as first-line treatment dominates

The addressable population is concentrated in Asian markets, where EGFR mutations are more common, but the U.S. and Europe generate substantial value because of higher pricing and broad use in metastatic and adjuvant settings.

How large is the Tagrisso market?

Tagrisso is the commercial leader in the EGFR-mutated NSCLC segment. Its market position comes from early-line use, relapse prevention, intracranial activity, physician familiarity, and a substantial clinical evidence base.

AstraZeneca’s reported sales trajectory is as follows:

Fiscal year	Tagrisso revenue	Approximate growth
2021	Approximately $5.0 billion	Double-digit growth
2022	Approximately $5.4 billion	Low-single-digit growth
2023	Approximately $5.8 billion	Approximately 7%
2024	Approximately $6.3 billion	Approximately 8% to 9%

Sources report sales using AstraZeneca’s product-sales presentation and constant-exchange-rate measures, so reported and CER growth can differ. AstraZeneca generated total revenue of approximately $54 billion in 2024, placing Tagrisso at about 11% to 12% of group revenue (AstraZeneca, 2025a).

Which countries contribute most to Tagrisso sales?

China is a major volume market because of the high prevalence of EGFR mutations. The United States and Europe contribute disproportionate revenue because of higher net prices and strong penetration in adjuvant and metastatic disease.

China also creates pricing pressure. National reimbursement negotiations, volume-based procurement, hospital access controls, and local competitors can reduce net price even when prescription volume rises. The Chinese market is strategically important for volume growth but is less favorable than the U.S. market for price realization.

What clinical developments are extending Tagrisso revenue?

Tagrisso’s financial trajectory depends on lifecycle expansion before loss of core exclusivity.

First-line monotherapy

The FLAURA study established osimertinib as a preferred first-line treatment for EGFR-mutated advanced NSCLC. The treatment’s progression-free and overall-survival results displaced earlier-generation EGFR inhibitors in many treatment guidelines.

Adjuvant treatment

Adjuvant Tagrisso after complete tumor resection expanded the product from metastatic treatment into early-stage disease. This indication increases the number of treated patients and creates longer-duration therapy, although the duration of treatment is typically limited to three years.

Combination with chemotherapy

The FLAURA2 regimen combines osimertinib with platinum-pemetrexed chemotherapy in the first-line setting. Combination use can increase treatment intensity and support revenue per patient, but adoption depends on toxicity, infusion burden, payer policy, and physician assessment of incremental benefit.

Unresectable stage III disease

The FDA approved Tagrisso for unresectable stage III EGFR-mutated NSCLC after chemoradiotherapy in December 2024. This indication places osimertinib earlier in the treatment sequence and may create an additional pool of patients receiving therapy before metastatic progression (FDA, 2024).

The stage III approval has strategic value because it may shift Tagrisso use toward earlier intervention. It also creates a duration-management issue: treatment in the stage III setting can overlap with or replace later metastatic use rather than represent entirely incremental patients.

When does Tagrisso lose exclusivity?

Tagrisso’s principal U.S. exclusivity risk is expected in the early 2030s, with the key composition-of-matter patent generally associated with expiration in 2032, subject to patent-term adjustment, pediatric extension, terminal disclaimers, and litigation outcomes.

Protection category	Estimated U.S. timing	Strategic relevance
FDA new chemical entity exclusivity	Expired in 2020	No longer blocks ANDA filing
Core osimertinib composition patent	Approximately 2032	Main generic-entry barrier
Formulation and salt patents	Generally later than core patent	Can complicate but may not prevent all generic entry
Method-of-use patents	Varies by indication	Can support infringement claims against labeled use
Pediatric exclusivity	Potentially added to listed protection	Depends on completed FDA requirements
International rights	Country-specific	Earlier or later entry is possible outside the U.S.

The distinction between ANDA filing and commercial launch is important. A generic manufacturer can file a Paragraph IV certification before expiration of the listed patents. Commercial entry may still be delayed by litigation, a settlement agreement, regulatory deficiencies, or a court injunction.

What patents protect Tagrisso?

The Tagrisso patent estate includes composition-of-matter, pharmaceutical-composition, method-of-use, and potentially manufacturing-related claims. The most valuable protection is the patent covering osimertinib or closely related chemical matter. Later patents generally have narrower scope and are more vulnerable to invalidity or non-infringement challenges.

Publicly identified U.S. patent families associated with Tagrisso include:

Patent family or protection type	Typical claim scope	Relative strength
Osimertinib chemical compound claims	Active pharmaceutical ingredient and related compounds	Strongest
Osimertinib mesylate or salt claims	Salt form and pharmaceutical presentation	Moderate to strong
Tablet and excipient formulations	Dosage-form composition and stability	Moderate
EGFR-mutant NSCLC treatment methods	Patient selection and dosing	Moderate
Adjuvant and stage III methods	Disease setting and treatment sequence	Variable
Combination therapy claims	Osimertinib with chemotherapy or other agents	Variable

The FDA Orange Book should be used for the current patent list, expiration dates, and reference-product information. Patent expiration dates can differ among related family members because of patent-term adjustment and terminal disclaimers (FDA, 2025a).

How strong is the Tagrisso patent estate?

The estate is commercially strong through the early 2030s because the core molecule has generated broad clinical use and the product has multiple approved indications. It is less certain after core-patent expiration because later formulation and method patents may not block an ANDA that uses a different formulation or carries a restricted label.

Method-of-use patents are particularly dependent on the generic label. A generic applicant may attempt a section viii statement that omits patented indications. That strategy can preserve a launch path even when AstraZeneca retains enforceable patents covering other uses.

Which companies are challenging Tagrisso patents?

Generic manufacturers that have filed or are associated with U.S. ANDA challenges to major oncology products can include large Indian, European, and U.S. generic companies. Tagrisso litigation has involved AstraZeneca and prospective generic manufacturers in federal patent proceedings and Paragraph IV disputes.

The relevant challenger categories include:

• Large multisource generic manufacturers.
• Specialty oncology companies seeking early entry.
• API manufacturers that can support an ANDA sponsor.
• Contract manufacturers with tablet-development capabilities.

A Paragraph IV certification states that an Orange Book-listed patent is invalid, unenforceable, or not infringed. AstraZeneca can sue within the statutory window, triggering a 30-month stay of FDA approval for the challenged ANDA, subject to statutory exceptions and court developments (FDA, 2025b).

Public litigation records and settlement terms should be reviewed separately for each defendant. A settlement can establish an authorized-generic launch date, an independent generic launch date, or a license subject to manufacturing and regulatory conditions. A litigation filing does not establish that generic entry will occur on the patent expiration date.

What is the FDA regulatory status of Tagrisso?

Tagrisso has full FDA approval across multiple treatment settings. It is not a biologic and therefore is not subject to biosimilar competition under the Biologics Price Competition and Innovation Act.

FDA milestone	Date
Initial approval for metastatic EGFR T790M-positive NSCLC	November 2015
First-line EGFR-mutated NSCLC approval	2017
Adjuvant treatment approval	2020
Osimertinib plus chemotherapy approval	2024
Unresectable stage III post-chemoradiation approval	December 2024

Because osimertinib is a small molecule, competitive products will generally enter through the ANDA pathway. A biosimilar is not the expected post-exclusivity threat.

How does Tagrisso compare with competing EGFR drugs?

Product	Active ingredient	Sponsor	Competitive position
Tagrisso	Osimertinib	AstraZeneca	Established first-line and adjuvant leader
Lazcluze	Lazertinib	Johnson & Johnson and Hangzhou Zhongmei Huadong	Approved with amivantamab in the U.S.
Rybrevant plus lazertinib	Amivantamab plus lazertinib	Johnson & Johnson	Combination alternative with infusion requirements
Alecensa	Alectinib	Roche	Primarily ALK-positive NSCLC, not direct EGFR competition
Gilotrif, Iressa, Tarceva	Earlier EGFR inhibitors	Multiple sponsors	Lower-cost alternatives with less favorable resistance and tolerability profiles
Aumolertinib	Aumolertinib	Jiangsu Hansoh and partners	Important China-based competitor
Furmonertinib	Furmonertinib	Chinese manufacturers	Growing China-market competition

Tagrisso’s key competitive weakness is that new EGFR regimens may offer differentiated efficacy in selected patients. Its key advantage is broad evidence across disease stages, established reimbursement, and oral administration.

What generic launch scenarios exist for Tagrisso?

Three scenarios are commercially plausible:

1. Entry shortly after core-patent expiration. This would produce the greatest price erosion and could accelerate payer substitution.
2. Delayed entry under settlement terms. AstraZeneca could preserve substantial value if authorized or licensed generic entry is postponed or limited.
3. Partial or indication-limited entry. A generic could launch with patented indications carved out, creating a fragmented market and reducing the immediate impact on protected uses.

Small-molecule oncology products often experience rapid gross-price erosion after multiple generic entrants, but net-price erosion depends on payer concentration, distribution contracts, shortage conditions, and the number of approved manufacturers.

What manufacturing and intellectual-property barriers remain?

Osimertinib is an orally administered small molecule, so manufacturing barriers are lower than for biologics or complex injectables. The main barriers are:

• Demonstrating bioequivalence.
• Controlling active-ingredient purity and polymorphic form.
• Reproducing dissolution and stability characteristics.
• Establishing a compliant commercial supply chain.
• Navigating Orange Book patents and method-of-use claims.
• Obtaining approval for a label that avoids infringement exposure.

AstraZeneca’s commercial defense is therefore more dependent on patent litigation, lifecycle management, clinical differentiation, and contracting than on manufacturing complexity.

What licensing deals affect Tagrisso competition?

AstraZeneca has used regional partnerships and licensing arrangements across its oncology portfolio, while Chinese companies have developed or partnered regional EGFR inhibitors. The most relevant licensing activity affects competing products such as lazertinib and other third-generation EGFR inhibitors rather than Tagrisso itself.

Licensing can accelerate competitor commercialization by transferring development, regulatory, and distribution rights. It can also expand the number of companies with incentives to challenge Tagrisso patents.

What is the revenue exposure from Tagrisso?

Tagrisso is a material concentration risk for AstraZeneca. At approximately $6.3 billion in 2024 sales, it represented about one-eighth of company revenue and a larger share of oncology revenue.

Revenue growth before 2032 is likely to depend on:

• Increased use in early-stage and stage III disease.
• Chemotherapy combination adoption.
• Continued first-line share retention.
• Expansion in China and other Asian markets.
• Price-volume tradeoffs in national reimbursement systems.
• Competitive pressure from lazertinib-based regimens.
• The timing and scope of U.S. generic entry.

The product’s risk profile changes sharply after core-patent expiry. Before then, growth is primarily a market-access and indication-expansion question. After then, it becomes a patent, settlement, and generic-share question.

Key Takeaways

• Tagrisso is AstraZeneca’s leading EGFR-mutated NSCLC product and generated approximately $6.3 billion in 2024 sales.
• The product’s main commercial protections are expected to extend into approximately 2032 in the United States.
• FDA NCE exclusivity has expired, but patent protection remains the principal barrier to generic entry.
• The 2024 approvals for chemotherapy combination therapy and unresectable stage III disease extend the lifecycle and expand the treatment population.
• Tagrisso faces small-molecule generic risk, not biosimilar risk.
• Lazertinib-based therapy is the most relevant emerging branded competitor in the United States.
• Post-expiration erosion will depend on Paragraph IV litigation, settlement terms, label carving, and the number of approved generic manufacturers.
• China offers substantial volume opportunity but carries elevated reimbursement and local-competition pressure.

FAQs About Tagrisso Market and Patent Risk

Is Tagrisso a biologic or a small-molecule drug?

Tagrisso is a small-molecule oral drug containing osimertinib mesylate. Generic competition is expected through the ANDA pathway rather than the biosimilar pathway.

What is the expected Tagrisso generic entry date?

The principal U.S. generic-entry risk is expected around the early 2030s, with core composition protection generally associated with expiration in approximately 2032. Litigation and settlement agreements could move actual entry earlier or later.

Does Tagrisso have Orange Book patents?

Yes. AstraZeneca has listed patents covering osimertinib-related chemical matter, pharmaceutical compositions, and methods of use. The FDA Orange Book is the controlling public source for current listings and expiration information.

Which drug is the strongest competitor to Tagrisso?

Lazertinib, particularly in combination with amivantamab, is the most direct U.S. branded competitor. Aumolertinib and furmonertinib are more relevant in China and selected international markets.

How much revenue could AstraZeneca lose after Tagrisso patent expiry?

The exposure is approximately the product’s annual revenue, which was about $6.3 billion in 2024 before accounting for continued growth, price changes, authorized-generic arrangements, and partial indication protection. Actual erosion will depend on the number and timing of generic launches.

References

AstraZeneca. (2025a). Annual report and Form 20-F 2024. AstraZeneca PLC.

AstraZeneca. (2025b). Full-year and fourth-quarter 2024 results. AstraZeneca PLC.

U.S. Food and Drug Administration. (2024). FDA approves osimertinib with or without chemotherapy for locally advanced, unresectable stage III EGFR-mutated NSCLC. U.S. Department of Health and Human Services.

U.S. Food and Drug Administration. (2025a). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

U.S. Food and Drug Administration. (2025b). Abbreviated new drug application approvals and patent certifications. U.S. Department of Health and Human Services.

U.S. Food and Drug Administration. (2020). FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer. U.S. Department of Health and Human Services.

Ramalingam, S. S., Van Schil, P. E., et al. (2021). Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. New England Journal of Medicine, 384(11), 1053-1064.

DrugChatter Q&A for TAGRISSO

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