EXKIVITY Drug Patent Profile

When do Exkivity patents expire, and when can generic versions of Exkivity launch?

Exkivity is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug.

This drug has sixty-five patent family members in forty countries.

The generic ingredient in EXKIVITY is mobocertinib succinate. Additional details are available on the mobocertinib succinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Exkivity

Exkivity was eligible for patent challenges on September 15, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 13, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EXKIVITY

International Patents:	65
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for EXKIVITY

EXKIVITY is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,227,342.

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
Takeda Pharms Usa	EXKIVITY	mobocertinib succinate	CAPSULE;ORAL	215310-001	Sep 15, 2021		DISCN	Yes	No	10,227,342		Y	Y
Takeda Pharms Usa	EXKIVITY	mobocertinib succinate	CAPSULE;ORAL	215310-001	Sep 15, 2021		DISCN	Yes	No
Takeda Pharms Usa	EXKIVITY	mobocertinib succinate	CAPSULE;ORAL	215310-001	Sep 15, 2021		DISCN	Yes	No	9,796,712		Y	Y
Takeda Pharms Usa	EXKIVITY	mobocertinib succinate	CAPSULE;ORAL	215310-001	Sep 15, 2021		DISCN	Yes	No

International Patents for EXKIVITY

When does loss-of-exclusivity occur for EXKIVITY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

Ukraine

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 EXKIVITY around the world.

Country	Patent Number	Title	Estimated Expiration
Georgia, Republic of	AP202014706
Japan	2021181486
Turkey	201903322
Japan	2021181486	キナーゼ阻害のためのヘテロアリール化合物 (HETEROARYL COMPOSITION FOR KINASE INHIBITION)

Supplementary Protection Certificates for EXKIVITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3157916	SPC/GB22/041	United Kingdom		PRODUCT NAME: MOBOCERTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, FOR EXAMPLE, MOBOCERTINIB SUCCINATE; REGISTERED: UK PLGB 16189/0124-0001 20220317
3157916	C03157916/01	Switzerland		PRODUCT NAME: MOBOCERTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68147 01.06.2022

Investment Scenario and Fundamental Analysis for EXKIVITY (Mobocertinib)

Last updated: February 26, 2026

What is EXKIVITY and its approved indications?

EXKIVITY (mobocertinib) is a targeted oral tyrosine kinase inhibitor developed by NantKwest Inc., approved by the U.S. Food and Drug Administration (FDA) on September 15, 2021[1]. It is indicated for adult patients with non-small cell lung carcinoma (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. These mutations are present in approximately 4–13% of NSCLC cases.

Market Landscape

Patient Population

The global NSCLC market accounts for approximately 2 million new cases annually[2]. Exon 20 insertion mutations are identified in 10–15% of EGFR-mutated NSCLC patients, representing an estimated patient population of 40,000 to 300,000 globally.

Competitive Dynamics

EXKIVITY operates in a niche with limited approved therapies. The primary competitors include:

• Amivantamab (Johnson & Johnson), approved in 2021 for NSCLC with EGFR exon 20 insertions.
• Investigational agents in Phase 1/2 trials, such as amgevita (AMG 510) and other novel TKIs.

Existing treatments include chemotherapy and immune checkpoint inhibitors, which have limited efficacy against exon 20 insertions. The drug landscape favors targeted therapies due to improved efficacy and tolerability.

Financial and Commercial Considerations

Pricing Strategy

• List Price: Approximately $13,600 per month, translating to around $163,000 annually[3].
• Revenue Potential: Based on estimated 40,000–300,000 eligible patients worldwide, with penetration rates of 10–20% in the initial years.

Sales Forecasts

Assuming a conservative 10% market penetration in the first three years and average selling price (ASP) of $163,000:

Year	Estimated Patients (Global)	Market Penetration	Potential Sales (USD)
2022	4,000	10%	$652 million
2023	6,000	15%	$977 million
2024	9,000	20%	$1.47 billion

These estimates depend on regulatory approvals, physician adoption, reimbursement policies, and competition intensity.

Pipeline and Development Dynamics

Ongoing Trials

• Phase 2 trials for broader indications, including other EGFR mutant NSCLCs and combination regimens.
• Adverse event profile includes diarrhea, rash, and stomatitis, similar to other EGFR inhibitors.

Regulatory and Manufacturing Factors

• U.S. FDA approval was based on the phase 1/2 trial (EXCLAIM-Lung study) demonstrating promising response rates.
• Manufacturing capacity and supply chain stability are critical for meeting demand.

Risks and Opportunities

Key Risks

• Competitive pressure from other targeted therapies such as amivantamab.
• Potential resistance development, reducing drug efficacy over time.
• Pricing and reimbursement barriers, especially in international markets.
• Regulatory hurdles in expanding indications.

Opportunities

• Expanding indications to other EGFR mutant NSCLCs.
• Combination therapies enhancing efficacy.
• Market expansion into Asia, which has significant NSCLC prevalence.

Investment Fundamentals

Metric	Data Point	Source
Peak Sales Potential	>$1.5 billion	Based on market size and pricing assumptions
R&D Investment	Estimated $500 million for pipeline expansion	Industry averages for similar targeted ONCO drugs
Market Penetration	Up to 20% in initial years	Industry benchmarks for niche targeted therapies

Key Takeaways

• EXKIVITY holds a significant position in treating a niche subset of NSCLC with unmet needs.
• Market opportunity exists, but competition and resistance pose challenges.
• Pricing strategies and regulatory approvals will influence revenue potential.
• Pipeline developments and combination therapies could broaden usage.
• The company’s ability to scale production and secure reimbursement will be pivotal.

FAQs

1. What distinguishes EXKIVITY from other EGFR inhibitors?
It selectively targets exon 20 insertion mutations, which are resistant to earlier generation EGFR inhibitors, offering a tailored treatment option.

2. What are the primary risks associated with investing in EXKIVITY?
Competitive pressure, potential resistance, reimbursement issues, and regulatory delays.

3. How does the pricing compare to similar targeted therapies?
Pricing aligns with other niche targeted therapies, typically between $10,000–$15,000/month.

4. Are there additional indications being developed for EXKIVITY?
Yes, ongoing trials aim to evaluate its use in other NSCLC subtypes and combination regimens.

5. What is the potential impact of international market entry?
Significant, given the high prevalence of NSCLC in Asia; regulatory approval and reimbursement will determine success.

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References

1. FDA. (2021). FDA approves Mobocertinib for lung cancer. https://www.fda.gov
2. Global Cancer Observatory (GLOBOCAN). (2020). Estimated cancer incidence worldwide. https://gco.iarc.fr
3. GoodRx. (2022). EXKIVITY pricing details. https://www.goodrx.com