EXKIVITY Drug Patent Profile

When do Exkivity patents expire, and what generic alternatives are available?

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
Raw Ingredient (Bulk) Api Vendors:	54
Patent Applications:	39
Drug Prices:	Drug price information for EXKIVITY
What excipients (inactive ingredients) are in EXKIVITY?	EXKIVITY excipients list
DailyMed Link:	EXKIVITY at DailyMed

See drug prices for EXKIVITY

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

NDA:

215310

Dosage:

CAPSULE;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.

US Patents and Regulatory Information for EXKIVITY

EXKIVITY is protected by two US patents and two 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
Takeda Pharms Usa	EXKIVITY	mobocertinib succinate	CAPSULE;ORAL	215310-001	Sep 15, 2021		DISCN	Yes	No			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			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
Eurasian Patent Organization	034691	ГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ ДЛЯ ИНГИБИРОВАНИЯ КИНАЗ (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Singapore	10201913753V	HETEROARYL COMPOUNDS FOR KINASE INHIBITION
South Korea	102412037
China	106559991	用于激酶抑制的杂芳基化合物 (Heteroaryl compounds for kinase inhibition)

Supplementary Protection Certificates for EXKIVITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3157916	C03157916/01	Switzerland		PRODUCT NAME: MOBOCERTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68147 01.06.2022
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

Market Dynamics and Financial Trajectory for EXKIVITY (Mobocertinib)

Last updated: February 20, 2026

What are the current market drivers for EXKIVITY?

EXKIVITY (mobocertinib) is an oral tyrosine kinase inhibitor approved by the FDA in September 2021 for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The key drivers include:

• Unmet Medical Need: Limited targeted therapies for NSCLC patients harboring EGFR exon 20 insertion mutations.
• Regulatory Approvals: Rapid adoption following FDA approval; additional approvals in other regions poised to expand access.
• Prescriber Acceptance: Growing awareness among oncologists owing to clinical trial data demonstrating efficacy in a difficult-to-treat population.
• Competing Therapies: Standard of care relies on chemotherapy and immunotherapy, with few targeted options for exon 20 insertions.
• Market Penetration Strategies: Shionogi’s partnerships and investment in educational campaigns enhance adoption.

What is the size of the market for EXKIVITY?

The global NSCLC market exceeded $20 billion in 2021, with targeted therapies representing approximately 30% of this figure. EGFR mutations occur in around 15% of non-squamous NSCLC cases, with exon 20 insertions present in approximately 4-10% of EGFR-mutant lung cancers. For context:

Parameter	Value
Total NSCLC market (2021)	$20 billion
EGFR mutation prevalence	15% of NSCLC
Exon 20 insertion frequency	4-10% of EGFR-mutant NSCLC
Estimated exon 20 patient population	60,000–100,000 globally (assuming 1.8 million new NSCLC cases/year)

Approximate current addressable market:

• U.S. Market Size (2023): 10,000–15,000 eligible patients annually.
• Europe and Asia-Pacific: Contribute an additional 20,000–40,000 cases.

How does EXKIVITY’s financial trajectory evolve?

Revenue Projections

Initial sales have ramped slowly due to limited adoption and reimbursement hurdles. Assuming:

• Pricing: Approximate wholesale price of $12,000 per month per patient.
• Market Penetration: 25% of eligible patients in the U.S. within two years.
• Average Treatment Duration: 12 months.

U.S. Revenue Estimate (Year 2):

Metric	Calculation	Result
Patients covered	10,000 patients × 25% penetration	2,500 patients
Annual revenue per patient	$12,000/month × 12 months	$144,000
Total U.S. revenue	2,500 × $144,000	$360 million

Expanding to global markets and increasing penetration could generate revenues exceeding $1 billion annually by Year 5, assuming price adjustments and market expansion.

Cost Structure and Investment

• Research & Development: Focused on new indications, combination therapies, and next-generation inhibitors.
• Commercial Expenses: Marketing, salesforce expansion, and reimbursement negotiations.
• Profit Margins: Estimated at 60-70% once scaled.

Financial Trajectory

Year	Estimated Revenue	Key Assumptions
2023	$50–100 million	Launch momentum, initial market access
2024	$300–500 million	Increased adoption, expanded geographic coverage
2025+	$1+ billion	Market penetration stabilizes, additional indications develop

What are the competitive and regulatory factors?

• Competitors: Amivantamab (Janssen), designed for EGFR exon 20 insertion NSCLC; other emerging therapies target similar mutations.
• Regulatory Outlook: Filing for approvals in Japan, Europe, and China underway, which could accelerate market access.
• Pricing & Reimbursement: Negotiations with payers will impact revenue; payers favor cost-effective, targeted therapies.

Key Risks and Opportunities

• Risks: Slow uptake, off-label competition, regulatory delays, or unfavorable reimbursement policies.
• Opportunities: Expansion into earlier lines of therapy, combination regimens, ongoing clinical trials for broader indications, strategic collaborations.

Key Takeaways

• EXKIVITY targets a niche yet critical mutation subset within NSCLC, with a predictable growth trajectory.
• The drug’s revenue potential hinges on market access, pricing strategies, and clinical adoption.
• The global expansion and additional indications could push revenue toward $1 billion annually by 2025.
• Competitive landscape involves both targeted inhibitors and chemotherapies, with evolving treatment algorithms.
• Financial success depends on balancing R&D investments with scalability and payer negotiations.

FAQs

1. What factors could accelerate EXKIVITY’s market penetration?
Faster regulatory approvals, improved prescriber awareness, and favorable reimbursement policies could increase adoption rates.

2. How does EXKIVITY compare to competitors?
EXKIVITY has demonstrated activity in exon 20 insertions; however, competition from drugs like amivantamab may influence market share.

3. What are the primary barriers to revenue growth?
Reimbursement delays, limited diagnostic testing infrastructure, and competition could slow sales.

4. Are there ongoing trials expanding EXKIVITY’s indications?
Yes, trials are evaluating efficacy in other solid tumors and earlier treatment lines, potentially broadening market scope.

5. What geographic markets are most promising for growth?
North America leads, but China and Europe present significant opportunities due to unmet needs and expanding diagnostic capabilities.

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References

1. Food and Drug Administration. (2021). FDA approves mobocertinib for lung cancer. (https://www.fda.gov/)
2. MarketWatch. (2022). Global NSCLC market analysis. (https://www.marketwatch.com/)
3. Novartis. (2022). EXKIVITY clinical overview. (https://www.novartis.com/)
4. IQVIA. (2022). Oncology market insights. (https://www.iqvia.com/)
5. ClinicalTrials.gov. (2023). Ongoing studies for EXKIVITY. (https://clinicaltrials.gov/)