Mobocertinib succinate - Generic Drug Details

What are the generic sources for mobocertinib succinate and what is the scope of patent protection?

Mobocertinib succinate is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mobocertinib succinate has sixty-five patent family members in forty countries.

Summary for mobocertinib succinate

International Patents:	65
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	12
DailyMed Link:	mobocertinib succinate at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 INSERTION MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY

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.

Anatomical Therapeutic Chemical (ATC) Classes for mobocertinib succinate

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

US Patents and Regulatory Information for mobocertinib succinate

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
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			Y	Y
Takeda Pharms Usa	EXKIVITY	mobocertinib succinate	CAPSULE;ORAL	215310-001	Sep 15, 2021		DISCN	Yes	No

International Patents for mobocertinib succinate

Country	Patent Number	Title	Estimated Expiration
Singapore	10201913753V	HETEROARYL COMPOUNDS FOR KINASE INHIBITION
Croatia	P20190407
Eurasian Patent Organization	034691	ГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ ДЛЯ ИНГИБИРОВАНИЯ КИНАЗ (HETEROARYL COMPOUNDS FOR KINASE INHIBITION)
Malaysia	186839
Georgia, Republic of	AP202014706
Japan	7212733
Singapore	11201610517P	HETEROARYL COMPOUNDS FOR KINASE INHIBITION

Supplementary Protection Certificates for mobocertinib succinate

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

Last updated: February 13, 2026

Summary

Mobocertinib succinate, marketed as Exkivity by Taiho Oncology and a few other partners, is an oral tyrosine kinase inhibitor targeting epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Since its FDA approval in September 2021, it has experienced moderate uptake within the non-small cell lung cancer (NSCLC) segment. Market dynamics are influenced by its targeted patient population, competitive landscape, and pricing strategies. Its financial trajectory depends on clinical adoption, reimbursement policies, and the expansion of indications.

What is the Current Market Position for Mobocertinib Succinate?

Approved Indication and Patient Population

• Indication: Treatment of adult patients with NSCLC harboring EGFR exon 20 insertion mutations.
• Target Population Size: Estimated at 10,000–15,000 US patients annually (based on NSCLC prevalence and mutation frequency).

Regulatory and Clinical Milestones

• FDA Approval: September 2021.
• Key Trial Data: ORR of 28% and median duration of response of 8.3 months in pretreated NSCLC patients with exon 20 insertions (Source: FDA approval document[1]).

Current Market Penetration

• Roughly 10% of NSCLC patients with EGFR mutations qualify.
• Early sales in the U.S. reached estimated $50-100 million in 2022, with sales growth predicted at 25-30% annually through 2025.

What Are the Key Market Drivers and Barriers?

Drivers

• Unmet Need: Few approved therapies offer targeted activity against exon 20 insertions.
• Efficacy Profile: Demonstrates significant activity with manageable toxicity.
• Patient Diagnosis Rates: Increased use of comprehensive genomic profiling enhances identification of eligible patients.

Barriers

• Limited Eligibility: Narrow indication exclusive to exon 20 insertion mutations.
• Competitors: Amivantamab (Rybrevant), another targeted therapy approved in 2021 for similar indications, captures part of this unmet market.
• Pricing and Reimbursement: List price approximately $15,000/month; reimbursement complexities impact uptake.

How Do Competitive and Pricing Strategies Shape Financial Outlook?

Competitive Landscape

• Other Agents: Amivantamab (monoclonal antibody) offers an alternative with similar efficacy.
• Pipeline: Several investigational agents aim to target exon 20, including mobocertinib competitors like amivantamab and newer agents in phase 1/2 trials.

Pricing Strategies

• Current Price: ~$15,000/month.
• Cost-Effectiveness: Cost per quality-adjusted life year (QALY) varies based on real-world efficacy; high cost could limit adoption unless justified by improved outcomes.
• Reimbursement Policies: Insurance coverage determinants impact sales volumes.

Revenue Projections

Year	Estimated Revenue (USD Millions)	Assumptions
2022	50-100	First year sales; steady growth in diagnosed eligible patients
2023	120-160	Adoption increase, payer coverage expansion
2024	180-220	Increasing use, potential label expansions
2025	250-300	Increased treatment days, broader awareness

What Are the Opportunities for Expansion?

• New Indications: Trials are ongoing for mobocertinib in other EGFR mutation subsets and possibly earlier lines.
• Combination Therapy: Studies combining mobocertinib with other agents are under consideration.
• Global Markets: Entry into Europe and Asia could expand market size, with regulatory decisions pending.

Key Risks and Limitations

• Market Entry of Next-generation Drugs: Innovative therapies could erode market share.
• Regulatory Delays: Potential delays in approval for expanded indications.
• Pricing Pressures: Payer pushback on high costs affecting reimbursement.

Conclusion

Mobocertinib succinate’s market remains growing but constrained to a niche patient group within NSCLC. Its financial trajectory depends on clinical efficacy, market penetration, and competition management. Its sales are projected to increase steadily over the next three years, assuming continued adoption and favorable reimbursement.

Key Takeaways

• Market size is limited primarily to NSCLC patients with EGFR exon 20 insertions—estimated at 10,000–15,000 annually in the US.
• Early sales suggest moderate initial adoption, with significant growth potential in subsequent years.
• Competition from agents like amivantamab and emerging therapies poses a risk to long-term market share.
• Pricing remains high, influencing reimbursement and profitability.
• Expansion beyond current indications could significantly alter revenue streams.

FAQs

1. How does mobocertinib compare with competing treatments? It offers a targeted oral option with activity against exon 20 insertions, whereas amivantamab is an intravenous bispecific antibody. Both have similar efficacy profiles, but oral administration may enhance patient convenience.

2. What is the scope of reimbursement for mobocertinib? Coverage depends on payor policies, but given its orphan indication, Medicaid and Medicare Part B are primary payers. High drug costs challenge coverage expansion.

3. Are there ongoing trials extending mobocertinib’s indications? Yes. Clinical trials are assessing efficacy in earlier lines of therapy, other EGFR mutation types, and combination regimens.

4. What are the risks to its market growth? Emerging therapies, price pressures, and limited indications restrict growth potential. Regulatory delays could also hinder expansion.

5. What is the outlook for international markets? Regulatory approval in Europe and Asia could substantially increase sales; negotiations and market access strategies are underway but face hurdles.

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References

1. FDA. (2021). FDA Approves Mobocertinib for Treatment of Certain Lung Cancers.