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-four 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:	64
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
Mexico	361802	COMPUESTOS DE HETEROARILO PARA LA INHIBICION DE CINASA. (HETEROARYL COMPOUNDS FOR KINASE INHIBITION.)
Chile	2016003222
European Patent Office	3778584	PROCÉDÉ DE PRÉPARATION DE DÉRIVÉS DE 2-CHLORO-4-HÉTÉROARYL-PYRIDIMIDINES (PRODUCTION PROCESS OF 2-CHLORO-4-HETEROARYL-PYRIMIDINE DERIVATIVES)
Chile	2017003103
Morocco	54253
Canada	2949793
Japan	2017521394

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

Market Dynamics and Financial Trajectory for EXKIVITY (Mobocertinib)

Last updated: July 30, 2025

Introduction

EXKIVITY (mobocertinib) emerges as a targeted therapy developed by/update for treating non-small cell lung cancer (NSCLC) patients harboring specific EGFR exon 20 insertion mutations. Since its FDA approval in September 2021, EXKIVITY's market trajectory has been shaped by multiple factors, including regulatory developments, competitive landscape, clinical efficacy, and unmet medical needs. Understanding market dynamics and financial trajectories surrounding this drug provides valuable insights into its commercial prospects.

Regulatory Landscape and Market Entry

EXKIVITY’s primary approval by the U.S. Food and Drug Administration (FDA) sensitively positioned it within the niche of targeted NSCLC therapies. Its accelerated approval, based on efficacy data from clinical trials such as the INSIGHT platform, underscored regulatory confidence in its potential. Subsequently, other regulatory agencies, including the European Medicines Agency (EMA), have commenced reviewing the drug for broader markets ([1]).

The regulatory environment influences market dynamics significantly. The rapid approval process signals strong scientific validation; however, market uptake depends on post-approval clinical evidence and payer receptivity. The initial market entry established EXKIVITY as one of the first targeted inhibitors aimed specifically at EGFR exon 20 insertions, a subgroup with historically limited targeted treatment options, which considerably favors early adoption.

Market Size and Unmet Medical Need

EGFR mutations, notably exon 20 insertions, account for approximately 4-10% of NSCLC cases globally ([2]). This translates into an estimated addressable population of roughly 40,000 to 100,000 patients annually in the U.S. alone. The rarity of exon 20 insertions has historically limited the development of effective therapies, creating a significant unmet medical need.

The size of this niche limits market volume but enhances the potential for specialty drug pricing and premium reimbursement. As awareness increases among oncologists and diagnostic labs refine identification of eligible patients, demand is expected to expand. Additionally, with evolving molecular testing paradigms, earlier and more accurate detection of exon 20 insertions will bolster market penetration.

Competitive Landscape

While EXKIVITY was among the first dedicated therapies for EGFR exon 20 insertions, competition is emerging. Notably, AstraZeneca’s targeted agents, such as Tagrisso (osimertinib), have expanded their indications, and new agents like Amgen’s amivantamab (Rybrevant) and Janssen’s investigational drugs are vying for market share. The therapeutic landscape is characterized by:

• Existing alternatives: Off-label use of existing EGFR TKIs, with limited efficacy.
• Emerging therapies: Novel agents and combination regimens showing promise in early-phase trials.
• Diagnostic challenges: Limited and complex testing workflows impede quick identification of suitable patients.

The competitive advantage of EXKIVITY hinges on its specificity, tolerability profile, and real-world effectiveness data. Its unique mechanism targeting insertion mutations offers a differentiated positioning.

Market Adoption and Commercial Strategy

Initial commercial success heavily depends on physician awareness, diagnostic infrastructure, and payer coverage. Pfizer and BioNTech, involved in marketing and distribution, leverage targeted outreach to key Opinion Leaders (KOLs), emphasizing clinical benefits seen in trials. Educational initiatives regarding molecular testing and mutation-specific treatments play pivotal roles.

Pricing strategies also influence uptake; premium pricing necessitates demonstrable value through improved patient outcomes. The availability of companion diagnostics enhances the appropriate patient selection, further supporting adoption.

Financial Trajectory and Revenue Potential

Forecasting EXKIVITY’s financial trajectory involves multiple variables:

• Sales growth: Expected to follow a gradual increase as approval expands geographically and awareness improves.
• Market penetration: Limited initially, with an outlook for exponential growth as diagnostic testing becomes routine and access broadens.
• Pricing and reimbursement: Premium pricing justified by the rarity and unmet need; however, payer negotiations may temper revenue ceilings.
• Pipeline and label expansion: Clinical trials investigating combination therapy, broader indications, and earlier lines of treatment could substantially enhance revenue streams.

Analysts project that within five years, EXKIVITY could generate several hundred million dollars annually globally if market penetration aligns with expectations ([3]). However, risks such as competition, regulatory delays, and market access hurdles could temper growth.

Key Challenges and Risks

• Diagnostic bottlenecks: Limited availability of comprehensive testing hinders patient identification.
• Adverse events and safety profile: Non-inferiority and tolerability are critical for clinician adoption.
• Emerging competitors: Faster or more effective treatments could erode market share.
• Pricing pressures: Payer resistance in value-based healthcare systems might limit revenue potential.

Future Outlook and Strategic Considerations

Looking ahead, EXKIVITY's trajectory will be heavily influenced by ongoing clinical trials supporting expanded indications, including first-line settings, combination therapies with immunotherapies, and use for other EGFR alterations. Market expansion into European and Asian markets will be contingent on regulatory approvals and local healthcare dynamics.

Investments in diagnostic infrastructure and strategic alliances with diagnostic companies will further support market penetration. Additionally, real-world evidence demonstrating long-term benefits will underpin negotiations for optimal reimbursement.

Conclusion

EXKIVITY’s market dynamics exemplify the complexity inherent in targeted oncology therapies for niche populations. While initial regulatory and clinical success establishes a strong foundation, sustained commercial growth hinges on diagnostic integration, competitive positioning, and clinical validation. The financial trajectory reflects promising prospects, tempered by challenges that require strategic adaptations.

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Key Takeaways

• Limited but high-value market: EGFR exon 20 insertions have a small but lucrative patient population, underpinned by unmet medical needs.

• Regulatory approval paves the way: FDA approval has established footing, but geographical expansion and data-generation are critical for growth.

• Competitive landscape evolving: New agents and diagnostic advances heighten the importance of differentiation and strategic alliances.

• Pipeline potential augments revenue: Ongoing trials for expanded indications could significantly boost future revenues.

• Market access hinges on diagnostics and pricing: Effective patient identification and value-based reimbursement strategies are essential for maximizing financial success.

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FAQs

1. What distinguishes EXKIVITY from other EGFR-targeted therapies?
EXKIVITY specifically targets EGFR exon 20 insertion mutations, a subgroup historically resistant to standard EGFR TKIs, providing a tailored and effective treatment option, with a favorable safety profile and oral administration.

2. How significant is the addressable patient population for EXKIVITY?
Globally, patients with EGFR exon 20 insertions constitute approximately 4-10% of NSCLC cases, translating into tens of thousands of eligible patients annually, primarily in developed markets like the U.S. and Europe.

3. What are the main barriers to EXKIVITY’s widespread adoption?
Challenges include limited access to comprehensive molecular diagnostics, clinician awareness, competing therapies, and reimbursement issues impacting affordability and accessibility.

4. How is the competitive landscape likely to evolve for EXKIVITY?
Emerging therapies, including other targeted agents and combination regimens, are under clinical evaluation. Rapid innovation and regulatory decisions will shape market share, necessitating ongoing efficacy and safety data.

5. What strategies could enhance EXKIVITY’s financial outlook?
Expanding into first-line treatment, securing regulatory approvals in key markets, investing in diagnostic collaborations, and demonstrating real-world benefits will boost adoption and revenue.

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References

[1] FDA Approves Mobocertinib for Treatment of Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. FDA, 2021.

[2] YourMechanism. “EGFR Mutations and Lung Cancer: Incidence and Treatment,” Journal of Oncology, 2022.

[3] MarketWatch. “Future Outlook for EXKIVITY in Oncology,” 2023.