Osimertinib mesylate - Generic Drug Details

What are the generic sources for osimertinib mesylate and what is the scope of freedom to operate?

Osimertinib mesylate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Osimertinib mesylate has one hundred and eighty-one patent family members in forty-three countries.

There are two drug master file entries for osimertinib mesylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for osimertinib mesylate

International Patents:	181
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for osimertinib mesylate
DailyMed Link:	osimertinib mesylate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for osimertinib mesylate

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 osimertinib mesylate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai JMT-Bio Inc.	PHASE3
Sichuan Baili Pharmaceutical Co., Ltd.	PHASE2
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.	PHASE2

See all osimertinib mesylate clinical trials

Generic filers with tentative approvals for OSIMERTINIB MESYLATE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET;ORAL
		40MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for osimertinib mesylate

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

Anatomical Therapeutic Chemical (ATC) Classes for osimertinib mesylate

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for OSIMERTINIB MESYLATE

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 osimertinib mesylate

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	208065-002	Nov 13, 2015		RX	Yes	Yes
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes			Y	Y
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			Y	Y
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No
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			Y	Y

International Patents for osimertinib mesylate

Country	Patent Number	Title	Estimated Expiration
Hungary	E026429
Costa Rica	20130629
European Patent Office	3009431
New Zealand	721298
Denmark	2736895
Montenegro	02382
Uruguay	34219

Supplementary Protection Certificates for osimertinib mesylate

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	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
1848414	122016000056	Germany		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
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	132016000078445	Italy		PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204

Market Dynamics and Financial Trajectory for Osimertinib Mesylate

Last updated: November 14, 2025

Introduction

Osimertinib mesylate, commercially known as Tagrisso, represents a significant advancement in targeted cancer therapy, particularly for non-small cell lung carcinoma (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations. Since its FDA approval in 2015, osimertinib’s market trajectory has been marked by rapid growth, driven by technological innovation, unmet medical needs, and expanding indications. This article analyzes the prevailing market dynamics and projects the financial trajectory of osimertinib mesylate within the global pharmaceutical landscape.

Market Overview and Therapeutic Context

Osimertinib is an oral third-generation EGFR tyrosine kinase inhibitor (TKI), designed to overcome resistance seen with earlier treatments like gefitinib or erlotinib. Its superior efficacy against T790M resistance mutations, coupled with a favorable safety profile, has positioned osimertinib as the standard of care in first-line NSCLC treatment.

The global NSCLC market was valued at approximately USD 17.8 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 7.4% through 2028 [1]. Osimertinib’s share within this segment has steadily increased, driven by its approval as first-line therapy, indicating a long-term growth trajectory.

Market Dynamics Influencing Osimertinib

1. Clinical Efficacy and Regulatory Approvals

Osimertinib’s clinical success, demonstrated through trials like FLAURA, underpins its market dominance. The trial showed improved progression-free survival (PFS) and overall survival (OS) compared to earlier-generation TKIs [2]. Regulatory bodies including the FDA, EMA, and other global agencies have expanded indications, bolstering market access. Recently, approvals for CNS metastasis treatment have further expanded its scope.

2. Competitive Landscape

The competitive environment includes drugs such as rociletinib, dacomitinib, and other emerging third-generation EGFR inhibitors. However, osimertinib’s proven efficacy and safety profile give it a dominant position. Patent protection until the late 2020s (with potential extensions) limits generic competition, allowing AstraZeneca to maintain premium pricing.

3. Patent Expiry and Generic Entry

Patent expiry in key markets could trigger significant price erosion. Nevertheless, AstraZeneca and partners are investing in lifecycle management strategies, including combination therapies and new indications, to sustain revenue streams post-patent expiry. The advent of generics may reduce prices by 40-60%, impacting profit margins but potentially expanding volume sales.

4. Market Penetration and Adoption

Early adoption in North America and Europe has been robust, facilitated by reimbursement support and clinical guideline endorsements. Emerging markets (Asia-Pacific, Latin America) present growth opportunities, although affordability and regulatory hurdles influence uptake rates. Market access restrictions can slow penetration but pose long-term revenue potential.

5. Pricing and Reimbursement Trends

Pricing strategies hinge on payor negotiations, value-based pricing models, and health economic assessments. In developed markets, osimertinib commands high price points (~USD 12,000–15,000 per month), justified by its clinical benefits. Reimbursement rates influence prescribing habits, directly impacting sales volume.

6. R&D Pipeline and New Indications

A robust pipeline involving combination regimens with immunotherapies and targeted agents promises future growth. New indications, including adjuvant therapy and uncommon mutations, could further extend its market lifespan. Regulatory submissions for these are ongoing, with approval expected in subsequent years.

Financial Trajectory Projections

Revenue Outlook (2023–2030)

Based on current adoption trends, clinical data, and pipeline potential, osimertinib’s global revenues are expected to grow from approximately USD 4.5 billion in 2022 to over USD 10 billion by 2030. This reflects a CAGR of roughly 10-12%, factoring in market maturation, patent cliffs, and emerging markets.

Key Revenue Drivers

• Expansion of Indications: First-line treatment approval and potential adoption as adjuvant therapy could dramatically increase patient populations.
• Geographical Expansion: Entry into underpenetrated regions, with tailored reimbursement strategies, will diversify revenue streams.
• Lifecycle Management: Combination therapies, new formulations, and biosimilars will influence sales volume and margins.

Market Risks

• Patent Challenges: Patent expirations or legal disputes could catalyze generic competition earlier than anticipated.
• Pricing Pressures: Increasing emphasis on value-based pricing and budget constraints in health systems could temper revenue growth.
• Regulatory Delays: Approval for new indications might be delayed or denied, limiting market expansion.

Pricing and Market Share Dynamics

AstraZeneca’s strategic positioning and negotiations will influence pricing strategies. The company aims to balance premium pricing with market access expansion, especially post-patent expiry. Market share is projected to stabilize around 70-80% in EGFR-mutant NSCLC therapy segments due to its efficacy profile, barring disruptive innovations or biosimilar incursions.

Long-term Outlook and Strategic Considerations

The pharmaceutical landscape anticipates intensified competition from next-generation molecules and combination regimens. However, osimertinib’s established position and ongoing pipeline enhancements suggest a resilient financial trajectory, with potential to sustain revenues until mid-2030s.

AstraZeneca’s investment in global clinical trials, companion diagnostics, and strategic collaborations will be critical in maintaining market competitiveness. Additionally, diversification into broader oncologic indications could further bolster long-term growth.

Key Takeaways

• Market dominance stems from osimertinib’s superior clinical efficacy, supported by regulatory approvals and clinical guidelines.
• Patent exclusivity is a crucial factor that currently safeguards premium pricing; expiry could challenge margins but offers volume growth opportunities.
• Emerging markets and new indications are vital avenues for expanding market share and revenue.
• Pipeline and combination therapies promise future revenue streams, maintaining relevance amid evolving oncology treatments.
• Pricing strategies will need to adapt to healthcare policy shifts, payor negotiations, and potential biosimilar entry.

FAQs

Q1: When is osimertinib expected to face generic competition?
Patent protection in major markets like the US is scheduled to expire around 2026–2028, opening the door for biosimilar and generic entrants. These could significantly impact pricing and market share.

Q2: What are the primary therapeutic advantages of osimertinib over earlier-generation EGFR inhibitors?
Osimertinib offers enhanced efficacy against T790M resistance mutations, better CNS penetration, and a favorable safety profile, resulting in improved patient outcomes.

Q3: Which emerging indications could significantly impact osimertinib’s market?
Potential approvals include adjuvant settings, early-stage NSCLC, and treatment of uncommon EGFR mutations, broadening its therapeutic scope.

Q4: How does osimertinib's pricing compare globally?
In developed countries, monthly costs range from USD 12,000 to USD 15,000, reflecting its clinical value. In emerging markets, prices are lower due to payor negotiations, impacting revenue potential.

Q5: What are the main risks that could hinder osimertinib’s growth?
Key risks include patent expiration leading to generic competition, regulatory delays for new indications, pricing pressures, and the emergence of more effective or cheaper competitors.

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Sources:
[1] Grand View Research, “Lung Cancer Therapeutics Market Size, Share & Trends Analysis Report,” 2022.
[2] Soria, J.C., et al. “Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer,” New England Journal of Medicine, 2018.