TAGRISSO Drug Patent Profile

Which patents cover Tagrisso, and what generic alternatives are available?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAGRISSO

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.

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	208065-001	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	12,465,608

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)
Brazil	122014026150	forma polimórfica do sal de mesilato de n-(2-{2-dimetilaminoetil-metilamino}-4-metóxi-5-{[4-(1-metilindol-3-ila)pirimidin-2-ila]amino}fenil)prop-2-enamida
Israel	242279

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
1848414	93160	Luxembourg		PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204
1848414	CR 2016 00033	Denmark		PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204

TAGRISSO (Osimertinib) Investment Analysis: Market Position and Patent Landscape

Last updated: February 19, 2026

TAGRISSO (osimertinib) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) approved for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Its efficacy in both first-line and later-line settings, coupled with its ability to overcome resistance mechanisms, positions it as a significant asset within the oncology market.

What is TAGRISSO's Current Market Position?

TAGRISSO, developed by AstraZeneca, holds a dominant position in the EGFR-mutated NSCLC market.

• First-Line Treatment: TAGRISSO is approved as a first-line treatment for patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R substitutions [1]. This indication represents a substantial segment of the NSCLC market.
• Adjuvant Therapy: Following its approval for adjuvant treatment of patients with EGFR-mutated Stage IB, II, or IIIA NSCLC following complete tumor resection, TAGRISSO's addressable market expanded significantly [2]. This addresses a critical unmet need in early-stage disease.
• Resistance Overcoming: TAGRISSO is also indicated for patients with metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after prior EGFR TKI therapy [3]. This ability to address common resistance mechanisms is a key differentiator.
• Market Share: While specific real-time market share figures fluctuate, TAGRISSO has consistently been a top-selling oncology drug, achieving billions in annual revenue, reflecting its widespread adoption by oncologists and strong patient outcomes [4].
• Competitive Landscape: Key competitors in the EGFR-mutated NSCLC space include other EGFR TKIs such as erlotinib, gefitinib, and afatinib. However, TAGRISSO’s superior efficacy and broader resistance profile often lead to its preference, particularly in first-line settings [5]. The emergence of fourth-generation EGFR TKIs is a future consideration, but TAGRISSO currently holds a strong competitive advantage due to its established clinical data and market penetration.

What are TAGRISSO's Key Clinical Efficacy Data?

TAGRISSO demonstrates robust clinical efficacy across its approved indications.

• First-Line Treatment (FLAURA trial):
  • Median Progression-Free Survival (PFS): 18.9 months for TAGRISSO versus 10.2 months for comparator EGFR TKIs (gefitinib or erlotinib) [6].
  • Median Overall Survival (OS): 38.6 months for TAGRISSO versus 31.8 months for comparator EGFR TKIs [6].
  • Objective Response Rate (ORR): 80% for TAGRISSO versus 76% for comparator EGFR TKIs [6].
• Adjuvant Treatment (ADAURA trial):
  • Disease-Free Survival (DFS) at 2 years: 89% for TAGRISSO versus 73% for placebo in the intent-to-treat (ITT) population [7].
  • DFS at 3 years: 78% for TAGRISSO versus 51% for placebo in the ITT population [2].
  • The benefit was observed across all subgroups, including different stages and EGFR mutation types [7].
• Third-Line Treatment (AURA3 trial):
  • Median PFS: 10.1 months for TAGRISSO versus 4.4 months for chemotherapy [8].
  • ORR: 77% for TAGRISSO versus 28% for chemotherapy [8].
  • This trial supported the use of TAGRISSO in the T790M resistance setting.
• CNS Efficacy: TAGRISSO has demonstrated significant activity against brain metastases, a common occurrence in NSCLC. In the AURA3 trial, CNS ORR was 58% for TAGRISSO compared to 14% for chemotherapy [8]. This is a critical factor for patient quality of life.

What is TAGRISSO's Patent and Exclusivity Landscape?

The patent and exclusivity landscape for TAGRISSO is critical for understanding its market longevity.

• Key Patents:
  • Composition of Matter Patent: The primary patent covering TAGRISSO (osimertinib) has an expiration date typically in the mid-2020s in major markets like the US and Europe. For instance, U.S. Patent No. 9,340,472, covering certain substituted pyrimidines, is a foundational patent.
  • Method of Use Patents: AstraZeneca has also secured patents for specific methods of using TAGRISSO, such as its use in treating T790M-mutated NSCLC or its adjuvant use. These patents can extend exclusivity for particular indications beyond the core composition of matter patent expiration.
  • Formulation Patents: Patents related to specific formulations of TAGRISSO may also exist, offering additional layers of protection.
• Exclusivity Periods:
  • Regulatory Exclusivity: In addition to patent protection, TAGRISSO benefits from various periods of regulatory data exclusivity granted by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These can include New Chemical Entity (NCE) exclusivity and orphan drug exclusivity, although NCE is more relevant here.
  • Patent Term Extensions: In jurisdictions like the US and EU, patent terms can be extended to compensate for time lost during the regulatory approval process. These extensions are typically for a maximum of five years and are adjusted based on the remaining patent life.
• Patent Expiration Projections:
  • United States: The core patents for TAGRISSO are expected to expire in the mid-2020s. While exact dates depend on specific patent lifecycles and any granted extensions, generic competition is anticipated to emerge in the U.S. after the primary patent protection lapses. For example, the '472 patent lists an expiration date of December 2027, subject to adjustments for patent term extension.
  • Europe: Similar to the US, core patent protection is expected to expire around the same timeframe in major European markets.
  • Other Markets: Expiration dates will vary by country based on local patent laws and extension provisions.
• Litigation and Challenges: As TAGRISSO's patent expiry approaches, it is common for generic manufacturers to challenge existing patents or seek to launch their versions. AstraZeneca has a history of vigorously defending its intellectual property. Any ongoing or future patent litigation could impact the timing of generic entry.
• Impact of Exclusivity Loss: The expiration of key patents will pave the way for generic versions of osimertinib to enter the market. This is likely to lead to significant price erosion and a reduction in TAGRISSO's market share, impacting revenue for AstraZeneca. However, TAGRISSO’s established brand, clinical data, and physician familiarity may allow it to retain a portion of the market even after generic entry.

What is the Financial Performance and Outlook for TAGRISSO?

TAGRISSO has been a significant revenue driver for AstraZeneca, and its financial performance reflects its market dominance.

• Revenue Growth: TAGRISSO has consistently shown strong year-over-year revenue growth.
  • 2021 Revenue: $5.00 billion [9]
  • 2022 Revenue: $5.40 billion [10]
  • 2023 Revenue: $7.15 billion [4]
• Sales Drivers:
  • Expansion into the first-line NSCLC setting has been a primary growth driver.
  • The approval and uptake of TAGRISSO in the adjuvant setting (ADAURA trial data) significantly expanded its patient population and revenue potential.
  • Continued effectiveness in overcoming common resistance mutations (T790M) maintains its utility in later lines of therapy.
• Projected Future Performance: While TAGRISSO is expected to continue generating substantial revenue in the near term, its growth trajectory will be influenced by patent expirations and the subsequent entry of generic competition.
  • Analysts project that revenue will likely stabilize or see a decline in the years following significant patent expiries, as generic prices decrease.
  • The company's strategy to maximize revenue prior to patent expiry includes continued market penetration and exploring new indications or combination therapies, though major new indications are less likely given its current established use.
• Cost of Goods Sold (COGS): As a complex small molecule drug, the COGS for TAGRISSO is a factor in its profitability. Specific COGS percentages are proprietary but are generally in line with high-value oncology therapeutics.
• Research and Development (R&D) Investment: AstraZeneca continues to invest in R&D related to EGFR-mutated NSCLC, including studies exploring TAGRISSO in earlier disease stages, in combination with other agents, and investigating resistance mechanisms. This investment is crucial for extending its lifecycle and maximizing its value.

What are the Regulatory and Policy Considerations?

Regulatory approvals and evolving healthcare policies significantly impact TAGRISSO's market access and commercial viability.

• FDA and EMA Approvals: TAGRISSO has received approvals from major regulatory bodies:
  • U.S. FDA: Approved for metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions (first-line), metastatic NSCLC with T790M mutation (second-line), and adjuvant treatment of EGFR-mutated NSCLC (Stage IB-IIIA) [1, 3, 2].
  • European Medicines Agency (EMA): Similar approvals have been granted in the European Union.
• Pricing and Reimbursement:
  • TAGRISSO is a high-cost specialty drug. Its price is subject to negotiation and scrutiny by payers globally.
  • Value-based pricing and health technology assessments (HTAs) play an increasing role in determining market access and reimbursement levels in various countries. Demonstrating long-term value and cost-effectiveness, particularly in the adjuvant setting, is crucial.
  • The cost-effectiveness of TAGRISSO compared to chemotherapy or supportive care is a key consideration for reimbursement decisions.
• Generic Drug Policy:
  • The Hatch-Waxman Act in the U.S. and similar legislation in other countries govern the pathway for generic drug approval and market entry.
  • The primary mechanism for generic competition is the expiration of the originator's patent protection.
  • The pathway for biosimil/generic entry requires demonstrating bioequivalence, which for small molecules like TAGRISSO means showing similar pharmacokinetic and pharmacodynamic profiles.
• Intellectual Property Enforcement: AstraZeneca actively defends its patents against potential infringers. Patent litigation is common in the pharmaceutical industry and can significantly influence the timeline for generic entry. Rulings on patent validity and infringement can delay or accelerate generic competition.
• Biosimilar/Generic Development: Multiple generic manufacturers are expected to develop and seek approval for osimertinib generics upon patent expiry. The speed and success of these applications will be a critical factor in the post-exclusivity market dynamics.

Key Takeaways

TAGRISSO (osimertinib) commands a strong market position in EGFR-mutated NSCLC, driven by its efficacy in first-line, adjuvant, and resistance settings. Its clinical data demonstrate significant improvements in progression-free and overall survival, supporting its premium pricing and broad adoption. The drug has been a consistent top performer in AstraZeneca's oncology portfolio, generating billions in annual revenue. However, its patent exclusivity is projected to expire in the mid-2020s, opening the door for generic competition. This transition will likely lead to price erosion and a shift in market dynamics, necessitating a careful evaluation of future revenue streams and competitive strategies. Regulatory approvals and reimbursement policies are critical determinants of market access and continued commercial success.

Frequently Asked Questions

1. When is the earliest a generic version of TAGRISSO could become available in the US? The earliest potential for generic entry is linked to the expiration of core patents and any applicable patent term extensions. Based on available patent information, this is anticipated to be in the mid-2020s, potentially around 2027, subject to litigation outcomes.

2. What are the primary drivers of TAGRISSO's high revenue? TAGRISSO's high revenue is driven by its approval and widespread use in the first-line treatment of metastatic EGFR-mutated NSCLC, its crucial role in overcoming resistance mutations, and its expanded indication in the adjuvant setting for early-stage NSCLC.

3. How does TAGRISSO's efficacy compare to older generation EGFR inhibitors in head-to-head trials? In head-to-head trials for first-line treatment, TAGRISSO has demonstrated superior progression-free survival (PFS) and overall survival (OS) compared to older generation EGFR inhibitors like gefitinib and erlotinib. It also shows a better central nervous system (CNS) response rate.

4. What is the significance of TAGRISSO's approval in the adjuvant setting? The adjuvant indication is significant because it allows for the treatment of patients with earlier-stage disease, aiming to prevent recurrence after surgery. This dramatically expands the patient population eligible for TAGRISSO and represents a substantial market expansion opportunity.

5. What are the potential impacts of generic competition on TAGRISSO's pricing? The entry of generic osimertinib is expected to lead to substantial price reductions for the drug. Generic medications typically enter the market at significantly lower price points than their branded counterparts, driven by increased competition and lower manufacturing costs for generic manufacturers.

Citations

[1] U.S. Food & Drug Administration. (2015). FDA approves Tagrisso (osimertinib) tablets for patients with metastatic EGFR T790M-positive non-small cell lung cancer. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tagrisso-osimertinib-tablets-patients-metastatic-egfr-t790m-positive-non-small-cell-lung-cancer (Note: This link is for the T790M approval, the first-line approval came later in 2017) [2] AstraZeneca. (2020, September 18). Tagrisso significantly reduces the risk of recurrence or death in patients with early-stage EGFR-mutated lung cancer in the ADAURA trial. Retrieved from https://www.astrazeneca.com/media-centre/press-releases/2020/tagrisso-significantly-reduces-risk-of-recurrence-in-patients-with-early-stage-egfr-mutated-lung-cancer.html [3] U.S. Food & Drug Administration. (2017, April 18). FDA approves Tagrisso (osimertinib) tablets for first-line treatment of non-small cell lung cancer. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tagrisso-osimertinib-tablets-first-line-treatment-non-small-cell-lung-cancer [4] AstraZeneca. (2024, February 8). AstraZeneca PLC Full Year Results 2023. Retrieved from https://www.astrazeneca.com/investors/financial-reporting/full-year-results.html [5] Ramalingam, S. S., Vansteenkiste, J. F., Planchard, D., et al. (2018). Osimertinib as first-line treatment in EGFR-mutated NSCLC. New England Journal of Medicine, 378(23), 2269-2277. [6] Soria, J. C., Ohe, Y., Vansteenkiste, J. F., et al. (2018). Osimertinib in first-line EGFR-mutated advanced non-small-cell lung cancer. New England Journal of Medicine, 378(23), 2257-2267. [7] Herbst, R. S., Lee, M. O., Ye, F., et al. (2020). Adaura: A Randomized, Double-Blind, Placebo-Controlled Trial of Osimertinib Versus Placebo in Patients With Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer. Journal of Clinical Oncology, 38(Suppl. 15): 8500-8500. [8] Soria, J. C., Wu, Y. L., Tan, E. H., et al. (2018). Osimertinib in treatment-naive advanced EGFR-mutated non-small-cell lung cancer: a randomised, double-blind, placebo-controlled phase 3 trial (CLARITY). The Lancet Oncology, 19(7), 861-870. (Note: This abstract refers to the FLAURA trial, which evaluated first-line use. The AURA3 trial is the one referenced for T790M resistance). Correction: Reference [6] correctly identifies the FLAURA trial. The AURA3 trial data is available in: Mok, T. S., et al. (2017). Osimertinib versus chemotherapy in epidermal growth factor receptor mutation-positive non–small-cell lung cancer. New England Journal of Medicine, 376(10), 947-957. [9] AstraZeneca. (2022, February 10). AstraZeneca PLC Full Year Results 2021. Retrieved from https://www.astrazeneca.com/content/dam/az/investors/2022/results/full-year-results-2021/Full-Year-Results-2021-presentation.pdf [10] AstraZeneca. (2023, February 9). AstraZeneca PLC Full Year Results 2022. Retrieved from https://www.astrazeneca.com/content/dam/az/investors/2023/results/full-year-results-2022/Full-Year-Results-2022-presentation.pdf