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.

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 July 25, 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:	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
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
China	114712362
Costa Rica	20160310

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
1848414	CR 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

TAGRISSO (osimertinib) Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What drives TAGRISSO’s market dynamics across lines of therapy?

TAGRISSO (osimertinib) is an EGFR-mutant NSCLC targeted therapy whose demand has been shaped by (1) expanding clinical positioning, (2) life-cycle management via combination and adjuvant strategies, (3) payer and guideline adoption dynamics, and (4) competitive pressure from other EGFR TKIs and next-generation agents.

Core demand drivers by segment

1) EGFR mutation testing penetration and guideline fit

• TAGRISSO demand tracks EGFR testing rates and the ability of payers and clinicians to align treatment choice to EGFR mutation status and line-of-therapy evidence.
• The product’s long-running presence in first-line and subsequent-line EGFR-mutant NSCLC maintains a “default option” profile in many formularies where guidelines incorporate osimertinib.

2) First-line label expansion and durable utilization

• Osimertinib is established in first-line EGFR-mutant advanced NSCLC, anchoring a large portion of global sales versus therapies positioned later in the pathway.
• The continued growth profile in earlier periods was driven by first-line uptake after pivotal evidence, and later by volume retention plus additional indications.

3) Adjuvant and perioperative life-cycle

• TAGRISSO’s adjuvant positioning (for resected EGFR-mutant NSCLC) creates an additional addressable population beyond metastatic lines, smoothing quarterly revenue patterns when advanced NSCLC volumes mature.
• Adjuvant uptake depends on surgery volumes, molecular testing, guideline adoption, and payer coverage.

4) Combination strategies that shift treatment sequencing

• Combination or expanded-regimen strategies (including integration with chemotherapy or other targeted approaches where evidence supports benefit) can reallocate patient flows across regimens.
• Where combinations improve outcomes and gain guideline endorsement, they can increase osimertinib patient starts or extend duration of treatment indirectly through earlier treatment adoption.

How has TAGRISSO’s financial trajectory evolved over time?

TAGRISSO’s financial trajectory is best read through AstraZeneca’s reported commercial performance for the brand globally. AstraZeneca reports the product line as part of its sales breakdown.

Reported sales (AstraZeneca, global)

AstraZeneca reports TAGRISSO under “Oncology” in its product sales schedules; the company also reports consolidated financials with product-level figures in earnings materials and annual reports.

The key public financial time series is accessible through AstraZeneca’s annual report and quarterly results archives. The most recent consolidated statements include line-item product growth or decline and the impact of geographic mix, pricing, and volume.

Observed trajectory pattern (directionally consistent with public results):

• Multi-year growth early in the life cycle driven by first-line adoption and expanding indications.
• Subsequent maturity as volumes normalize, competition intensifies, and pricing benefits face pressure.
• Ongoing resilience from life-cycle expansions (notably adjuvant) offsetting some erosion risk in metastatic disease.

What the financial trajectory implies for underwriting and valuation

From a business perspective, TAGRISSO’s revenue model behaves like a mature blockbuster with:

• strong baseline demand anchored by guideline placement in EGFR-mutant advanced NSCLC,
• incremental, indication-driven add-ons in earlier disease settings,
• volatility tied to competitive dynamics and payer reimbursement.

What market events and competitor forces shape revenue momentum?

Primary competitive pressure

TAGRISSO competes with other EGFR TKIs and targeted therapies across EGFR-mutant NSCLC lines and with broader oncology standards that may change treatment sequencing over time.

Competitor pressure typically shows up through:

• Formulary renegotiations and payer step edits when competing EGFR TKIs gain coverage.
• Sequencing change when clinical evidence supports alternative first-line or post-progression strategies.
• Patent and access events that can alter net pricing in certain markets.

Generic risk and patent-life cycle impact (timing-dependent)

While the brand’s core market position remains strong, long-term financial trajectory depends on the patent estate, market exclusivity timelines, and localized regulatory approvals for generics/biosimilars or authorized follow-on products.

The practical implication is a staged risk curve:

• Near-term: driven more by clinical uptake, payer dynamics, and competitor efficacy rather than generic erosion.
• Mid-to-long term: increasingly tied to patent expiry landscapes and regulatory exclusivity in each major geography.

How do geography and payer dynamics influence realized sales?

Major geography drivers

TAGRISSO is a global product with meaningful contributions from:

• United States (largest oncology drug reimbursement market; uptake tied to managed care coverage and patient volume).
• Europe (guideline-driven reimbursement patterns; value frameworks).
• Japan and other developed Asian markets (molecular testing penetration and local formularies).

Payer mechanics that affect net sales

Revenue momentum for TAGRISSO is sensitive to:

• Rebate and discount structures through pharmacy benefit managers and national health reimbursement agencies.
• Coverage policies tied to companion diagnostics and biomarker confirmation.
• Utilization management such as prior authorization and step therapy.

What product-level portfolio moves support TAGRISSO’s financial runway?

Indication expansion logic

AstraZeneca has used multi-stage development to expand osimertinib’s treatable population:

• advanced EGFR-mutant NSCLC across line settings,
• resected disease via adjuvant approaches,
• additional combinations where clinical benefit supports guideline uptake.

These moves generally:

• extend the addressable market,
• reduce reliance on late-line volumes,
• stabilize demand when first-line growth slows.

What are the key economic variables behind margin and growth?

Demand elasticity factors

• Volume sensitivity: depends on eligible patient counts driven by EGFR mutation prevalence, testing rates, and treatment adoption.
• Net pricing sensitivity: depends on pricing pressure, tender outcomes in some markets, and rebate trends.

Cost structure variables

• Commercial spend: supports retention and expansion across geographies and disease settings.
• Manufacturing scale: as volumes grow or shift across indications, unit costs can improve or rise depending on production planning.

What does the financial trajectory indicate for R&D and investment positioning?

TAGRISSO’s market behavior supports three investment-grade conclusions:

1. Guideline anchoring: demand is tied to EGFR pathway standard-of-care.
2. Life-cycle continuation: adjuvant and regimen expansions extend the horizon beyond metastatic treatment.
3. Net sales risk management: long-term performance depends on net price discipline and managed competition rather than pure patient volume growth.

How resilient is TAGRISSO to competitive switching and sequencing changes?

Resilience is strongest when:

• osimertinib remains the preferred therapy in first-line settings,
• adjuvant programs maintain steady patient starts,
• competitive alternatives do not displace clinician preference in biomarker-confirmed populations.

Erosion accelerates when:

• competitors win first-line or post-progression placements,
• payers implement stronger utilization controls favoring lower-cost alternatives,
• clinical practice shifts toward other agents with superior outcomes in a specific subgroup.

Key Takeaways

• TAGRISSO’s market dynamics are anchored by EGFR testing penetration and entrenched first-line guideline fit.
• Financial trajectory shows a mature blockbuster pattern: early growth driven by uptake, followed by normalization and resilience through life-cycle indication expansion.
• Revenue momentum depends on net pricing and payer utilization management as much as on trial-driven label expansion.
• The biggest medium- to long-term swing factor is competitive sequencing combined with country-level exclusivity and access dynamics.

FAQs

1) What does TAGRISSO sell for primarily?

TAGRISSO is sold as a targeted EGFR TKI for EGFR-mutant NSCLC, with major revenue coming from advanced disease settings and ongoing contribution from resected/adjuvant positioning where adopted.

2) What most affects TAGRISSO revenue each quarter?

Net sales movement typically reflects changes in patient volume (starts and persistence) and net pricing (rebates, discounts, tender outcomes), plus geographic mix and payer contracting.

3) Is TAGRISSO still expanding its addressable market?

Yes. The brand’s commercial model includes indication expansion beyond metastatic lines, including adjuvant strategies that broaden eligible populations.

4) How does competition typically impact osimertinib?

Competition affects TAGRISSO through payer coverage changes, clinician sequencing decisions, and differential outcomes by patient subgroup, which can shift patient starts away from osimertinib in specific settings.

5) What is the main business risk for TAGRISSO?

The dominant risks are sustained net price pressure and competitive displacement in key line-of-therapy positions, with longer-term generic/exclusivity risk governed by geography and patent lifetime.

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References

[1] AstraZeneca. (2024). Annual report and accounts (product sales and segment disclosures including oncology brands). AstraZeneca. https://www.astrazeneca.com/investors/financial-information/annual-results.html
[2] AstraZeneca. (2025). Quarterly results archive (financial statements and product performance commentary in earnings materials). AstraZeneca. https://www.astrazeneca.com/investors/financial-information/quarterly-results.html
[3] AstraZeneca. (2024). Form 20-F / investor financial statements (AstraZeneca investor filings with product and segment disclosures). AstraZeneca. https://www.astrazeneca.com/investors/sec-filings.html

DrugChatter Q&A for TAGRISSO

Dailymed tagrisso osimertinib initial u.s. approval 2015 indications?
Dailymed tagrisso osimertinib initial u's approval 2015 indications?
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