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 seventy-nine 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 five 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:	179
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	69
Patent Applications:	46
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
Jonathan Riess	Phase 1
TYK Medicines, Inc	Phase 2
Southwest Oncology Group	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.

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

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
Hungary	E037645
Slovenia	3009431
South Korea	20140047741

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	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	CA 2016 00033	Denmark		PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204

Market Dynamics and Financial Trajectory for Tagrisso

Introduction to Tagrisso

Tagrisso, developed by AstraZeneca, is a small-molecule kinase inhibitor specifically designed to treat non-small cell lung cancer (NSCLC) patients with certain EGFR mutations. First approved in 2015, Tagrisso has since become a cornerstone in the treatment of NSCLC, particularly for patients with the EGFR T790M mutation and those with EGFR exon 19 deletions or exon 21 (L858R) mutations.

Approval and Clinical Significance

Tagrisso's approval marked a significant advancement in lung cancer treatment. Initially approved for second-line treatment, it later received first-line approval in 2018 and adjuvant approval in 2020. The Phase III FLAURA and ADAURA trials demonstrated its efficacy in first-line and adjuvant settings, respectively, solidifying its position in the treatment landscape[4].

Market Position and Projections

Sales Performance

Tagrisso has emerged as AstraZeneca's biggest-selling drug. In 2022, it generated $5.44 billion in sales, a 15% increase from 2021. This growth is expected to continue, with projected sales surpassing $7 billion by 2029, giving Tagrisso a 48% market share of small molecules in lung cancer treatment[3][4].

Market Share and Competitors

In the small-molecule segment of the NSCLC market, Tagrisso is projected to lead, followed by Roche with anticipated sales of over $2.5 billion and a market share of 17%. Amgen is expected to secure the third position with projected sales of over $1 billion and a market share of 7.3%[4].

Overall NSCLC Market

While Tagrisso dominates the small-molecule segment, the overall NSCLC market is led by immunotherapies, particularly Merck’s Keytruda, which generated nearly $21 billion in sales in the previous year. However, small molecules like Tagrisso are carving out a significant niche, with the total small-molecule market in NSCLC expected to reach over $15 billion by 2029[3].

Financial Trajectory

Revenue Growth

Tagrisso's revenue has been consistently strong. In the first half of 2024, Tagrisso sales increased by 8% (12% at constant exchange rates), contributing significantly to AstraZeneca's total revenue growth of 18%[5].

Total Revenue Impact

AstraZeneca's total revenue, driven in part by Tagrisso, has seen substantial growth. For the first half of 2024, the company reported a total revenue of $25,617 million, with an 18% increase at constant exchange rates. Tagrisso's performance is a key driver of this growth, particularly within the oncology segment, which saw a 15% (19% at CER) increase in revenue[5].

Drivers of Growth

Clinical Trials and Approvals

The robust clinical trial landscape, including the successful outcomes of the FLAURA and ADAURA trials, has been a significant driver of Tagrisso's growth. These trials have expanded its indications, making it a standard treatment in both first-line and adjuvant settings for EGFR-mutant NSCLC patients[4].

Global Demand

Strong global demand for Tagrisso, particularly in the eight major markets (U.S., France, Germany, Italy, Spain, U.K., Japan, and China), is another key factor. This demand is driven by the drug's efficacy and the increasing prevalence of NSCLC with EGFR mutations[3][4].

Competitive Landscape

Targeted Therapies

Tagrisso competes within a broader landscape of targeted therapies for NSCLC. Other notable drugs include Roche’s Avastin and Eli Lilly’s Cyramza, which also contribute to the growth of the targeted therapy segment. However, Tagrisso's high CAGR of 56.6% sets it apart, making it one of the fastest-growing drugs in this class[1].

Immunotherapies

While small molecules like Tagrisso are significant, the NSCLC market is also dominated by immunotherapies such as Merck’s Keytruda and Bristol Myers Squibb’s Opdivo. These drugs have multiple indications and approvals, but Tagrisso's niche in EGFR-mutant NSCLC ensures its market relevance[3].

Unmet Needs and Future Outlook

Ongoing Clinical Trials

The NSCLC market continues to evolve with ongoing clinical trials. As of the latest reports, there are 4,951 ongoing Phase III trials employing 34 distinct small molecules globally, indicating a robust and dynamic clinical trial landscape. This includes new small molecules from AstraZeneca and other companies, which could further expand the treatment options for NSCLC patients[4].

Pipeline Drugs

AstraZeneca's pipeline, including drugs like Orpathys and Lynparza, is expected to contribute to the company's small-molecule lung cancer treatment portfolio. These drugs are undergoing clinical trials and are anticipated to generate additional revenue by 2029[4].

Key Takeaways

• Market Leadership: Tagrisso is projected to lead the small-molecule segment of the NSCLC market with anticipated sales surpassing $7 billion by 2029.
• Revenue Growth: Tagrisso's sales have consistently grown, contributing significantly to AstraZeneca's total revenue.
• Clinical Significance: The drug's approvals in first-line and adjuvant settings have marked significant advancements in NSCLC treatment.
• Global Demand: Strong demand in major markets drives Tagrisso's growth.
• Competitive Landscape: Tagrisso competes within a landscape dominated by immunotherapies but carves out a significant niche in EGFR-mutant NSCLC.

FAQs

What is Tagrisso used for?

Tagrisso is used to treat non-small cell lung cancer (NSCLC) patients with specific EGFR mutations, including the EGFR T790M mutation and those with EGFR exon 19 deletions or exon 21 (L858R) mutations.

How much revenue did Tagrisso generate in 2022?

In 2022, Tagrisso generated $5.44 billion in sales, a 15% increase from 2021.

What is the projected market share of Tagrisso by 2029?

By 2029, Tagrisso is projected to have a 48% market share of small molecules in lung cancer treatment.

Which other companies are significant players in the NSCLC market?

Other significant players include Merck with Keytruda, Roche with Avastin, and Bristol Myers Squibb with Opdivo.

What is the current clinical trial landscape for NSCLC small molecules?

There are 4,951 ongoing Phase III trials employing 34 distinct small molecules globally, indicating a robust and dynamic clinical trial landscape.

Sources

1. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. Drug Development.
2. AZN: First quarter 2021 results. Investis.
3. AstraZeneca's Tagrisso to lead niche lung cancer market. FiercePharma.
4. AstraZeneca's Tagrisso to lead lung cancer small molecule market with over $7 bn sales by 2029: GlobalData. Express Pharma.
5. AstraZeneca 25 July 2024 H1 and Q2 2024 results. AstraZeneca.