OSIMERTINIB MESYLATE - Generic Drug Details

What are the generic drug 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 seventy-six 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:	176
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:	7
Patent Applications:	2,701
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

Constraining patent/regulatory exclusivity:

10,183,020

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
Sichuan Baili Pharmaceutical Co., Ltd.	Phase 2
Klus Pharma Inc.	Phase 2
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.	Phase 2

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	10,183,020		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	9,732,058		Y	Y
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes	9,732,058		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
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes	11,524,951		Y	Y

International Patents for OSIMERTINIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
Spain	2654177
Peru	20141700	COMPUESTOS DE 2-(2,4,5-ANILINO SUSTITUIDO) PIRIMIDINA
Hungary	E037645
Eurasian Patent Organization	033733	ПРОИЗВОДНЫЕ 2-(2,4,5-ЗАМЕЩЕННОГО АНИЛИНО)ПИРИМИДИНА В КАЧЕСТВЕ МОДУЛЯТОРОВ EGFR, ПОЛЕЗНЫХ ДЛЯ ЛЕЧЕНИЯ РАКА, И ПРОМЕЖУТОЧНЫЕ СОЕДИНЕНИЯ ДЛЯ ИХ ПОЛУЧЕНИЯ (2-(2,4,5-SUBSTITUTED-ANILINO)PYRIMIDINE DERIVATIVES AS EGFR MODULATORS USEFUL FOR TREATING CANCER AND INTERMEDIATES FOR MANUFACTURE THEREOF)
Cyprus	1120072
Israel	242279	תרכובות מותמרות של 3-כלורו- n-[3-(פירימידינ-2-ילאמינו) פניל]פרופאנאמיד ומלחיהן (Substituted 3-chloro-n-[3-(pyrimidin-2-ylamino)phenyl]propanamide compounds and salts thereof)
Eurasian Patent Organization	024421	N-(2-{2-ДИМЕТИЛАМИНОЭТИЛ-МЕТИЛАМИНО}-4-МЕТОКСИ-5-{[4-(1-МЕТИЛИНДОЛ-3-ИЛ)ПИРИМИДИН-2-ИЛ]АМИНО}ФЕНИЛ)ПРОП-2-ЕНАМИД И ЕГО ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫЕ СОЛИ В КАЧЕСТВЕ МОДУЛЯТОРОВ EGFR, ПОЛЕЗНЫХ ДЛЯ ЛЕЧЕНИЯ РАКА (N-(2-{2-DIMETHYLAMINOETHYL-METHYLAMINO}-4-METHOXY-5-{[4-(1-METHYLINDOL-3-YL)PYRIMIDIN-2-YL]AMINO}PHENYL)PROP-2-ENAMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF AS EGFR MODULATORS USEFUL FOR TREATING CANCER)

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	132016000078445	Italy		PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204
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	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

OSIMERTINIB MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Osimertinib Mesylate

Introduction

Osimertinib mesylate, marketed under the brand name Tagrisso, is a groundbreaking medication in the treatment of non-small cell lung cancer (NSCLC), particularly for patients with specific epidermal growth factor receptor (EGFR) mutations. Here, we delve into the market dynamics and financial trajectory of this critical drug.

Market Size and Growth Projections

The global osimertinib market is experiencing rapid growth, driven by increasing demand for effective treatments for NSCLC.

• As of 2024, the global osimertinib market size is estimated at USD 4,969.02 million, with a projected compound annual growth rate (CAGR) of 16.00% from 2024 to 2031[2].
• Another report indicates that the market will grow from $5.66 billion in 2023 to $6.66 billion in 2024, at a CAGR of 17.8%, and is expected to reach $12.09 billion by 2028[3].
• By 2031, the market is projected to reach USD 13.2 billion, growing at a CAGR of 15.63% during the forecast period[4].

Regional Market Analysis

The osimertinib market is segmented across various regions, each exhibiting distinct growth patterns:

• North America: Held more than 40% of the global revenue in 2024, with a market size of USD 1,987.61 million and a CAGR of 14.2% from 2024 to 2031[2].
• Europe: Accounted for over 30% of the global revenue in 2024, with a market size of USD 1,490.71 million and a CAGR of 14.5% from 2024 to 2031[2].
• Asia Pacific: Represented around 23% of the global revenue in 2024, with a market size of USD 1,142.87 million and a CAGR of 18.0% from 2024 to 2031. China is expected to project the highest CAGR in this region[2][5].
• South America: Held around 5% of the global revenue in 2024, with a market size of USD 248.45 million and a CAGR of 15.4% from 2024 to 2031[2].
• Middle East and Africa: Accounted for around 2% of the global revenue in 2024, with a market size of USD 99.38 million and a CAGR of 15.7% from 2024 to 2031[2].

Market Segmentation

The osimertinib market is segmented based on several key factors:

• Type: Available in 40 mg and 80 mg formulations[3].
• Distribution Channel: Primarily distributed through hospital pharmacies, drug stores and retail pharmacies, and online pharmacies[3].
• Application: Mainly used for treating locally advanced and metastatic NSCLC, with other applications also being explored[3].

Drivers of Market Growth

Several factors are driving the growth of the osimertinib market:

• R&D Investment and Innovation: Continuous research and development, along with successful clinical trials, have significantly contributed to the market's growth[3].
• Targeted Therapy: Osimertinib's targeted therapy approach, especially for patients with specific EGFR mutations, has enhanced its adoption[3].
• Patient-Centric Care: The integration of precision medicine and patient-centric care has further boosted the market[3].
• Global Market Expansion: Expanding into new markets and regions is another key driver[3].

Challenges and Restraints

Despite the robust growth, the osimertinib market faces several challenges:

• High Costs: The high cost of osimertinib, ranging from $9,117.36 to $17,028.90 per month in the US, is a significant restraint. This cost is attributed to the complexity of the manufacturing process and the limited patient population[3].
• Availability of Counterfeit Products: The presence of counterfeit products in the market can inhibit growth by eroding trust and affecting sales of genuine products[5].

Impact of COVID-19

The COVID-19 pandemic had a positive impact on the osimertinib market:

• Increased Demand: The pandemic led to an increased demand for oncology medicines, including osimertinib, as it is crucial for managing lung cancer and improving patient outcomes during the pandemic[5].

Key Players and Competitive Landscape

The market is dominated by several key players who are investing heavily in research and development to enhance the efficacy and availability of osimertinib:

• Major players are focusing on developing effective medications and expanding their market presence through strategic initiatives[5].

Distribution and Sales Channels

The distribution of osimertinib is primarily through:

• Hospital Pharmacies: Holding the largest market share in 2021, hospital pharmacies remain a critical distribution channel[5].
• Drug Stores and Retail Pharmacies: These channels also play a significant role in the distribution of osimertinib[3].
• Online Pharmacies: Online sales are becoming increasingly important, especially in regions with high internet penetration[3].

Financial Performance and Revenue Streams

The financial performance of the osimertinib market is robust, with significant revenue streams from various regions and distribution channels:

• The market value is defined by the revenues generated from the sale of goods and services within the specified market and geography, including related services sold by the creators of the goods[3].

Future Outlook

The future outlook for the osimertinib market is promising, with several trends expected to shape the market:

• Biosimilar Entry: The potential entry of biosimilars could introduce market competition and affect pricing strategies[3].
• Liquid Biopsy Adoption: The increasing adoption of liquid biopsies and genomic profiling advancements are expected to enhance the market[3].
• Resistance Management Strategies: Developing strategies to manage resistance to osimertinib will be crucial for sustained growth[3].

Key Takeaways

• The osimertinib market is experiencing rapid growth driven by R&D investments, targeted therapy, and global market expansion.
• High costs and the availability of counterfeit products are significant restraints.
• The COVID-19 pandemic positively impacted the market by increasing demand for oncology medicines.
• Key players are investing in research and development to enhance market presence.
• Hospital pharmacies and online channels are critical distribution channels.

FAQs

What is the current market size of the osimertinib mesylate market?

The global osimertinib market size was estimated at USD 4,969.02 million in 2024[2].

What is the projected CAGR for the osimertinib mesylate market from 2024 to 2031?

The market is expected to grow at a CAGR of 16.00% from 2024 to 2031[2].

Which region holds the largest market share for osimertinib mesylate?

North America holds more than 40% of the global revenue, with a market size of USD 1,987.61 million in 2024[2].

What are the main applications of osimertinib mesylate?

Osimertinib is primarily used for treating locally advanced and metastatic non-small cell lung cancer (NSCLC)[3].

What are the major challenges facing the osimertinib mesylate market?

High costs and the availability of counterfeit products are significant challenges[3][5].

Sources

1. Market Research Intellect - Global Pharmaceutical Grade Osimertinib Mesylate Market Size...
2. Cognitive Market Research - Osimertinib Market will Grow at a CAGR of 16.00% from 2024 to 2031.
3. The Business Research Company - Global Osimertinib Drugs Market Report 2024
4. Verified Market Research - Tagrisso (Osimertinib) Market Size, Scope, Growth and Forecast
5. Astute Analytica - Osimertinib Drugs Market Size, Growth, Forecast [2027]