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Last Updated: July 14, 2025

Mobocertinib succinate - Generic Drug Details


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What are the generic drug sources for mobocertinib succinate and what is the scope of freedom to operate?

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-four patent family members in forty countries.

Summary for mobocertinib succinate
International Patents:64
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
Generic Entry Date for mobocertinib succinate*:
Constraining patent/regulatory exclusivity:
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 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 ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa EXKIVITY mobocertinib succinate CAPSULE;ORAL 215310-001 Sep 15, 2021 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Takeda Pharms Usa EXKIVITY mobocertinib succinate CAPSULE;ORAL 215310-001 Sep 15, 2021 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Takeda Pharms Usa EXKIVITY mobocertinib succinate CAPSULE;ORAL 215310-001 Sep 15, 2021 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for mobocertinib succinate

Country Patent Number Title Estimated Expiration
European Patent Office 3409669 COMPOSÉS HÉTÉROARYLES POUR INHIBITION DE KINASE (HETEROARYL COMPOUNDS FOR KINASE INHIBITION) ⤷  Try for Free
Turkey 201903322 ⤷  Try for Free
Chile 2017003103 Compuestos de heteroarilo para la inhibición de cinasa ⤷  Try for Free
South Korea 102628356 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for mobocertinib succinate

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

Market Dynamics and Financial Trajectory of Mobocertinib Succinate

Last updated: July 6, 2025

Introduction

In the competitive landscape of oncology pharmaceuticals, mobocertinib succinate emerges as a targeted therapy for non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations. Developed by Takeda Pharmaceutical Company, this drug addresses a critical unmet need in precision medicine. As investors and business leaders navigate volatile markets, understanding the drug's market dynamics and financial outlook provides actionable insights for strategic decision-making. This analysis delves into current trends, regulatory hurdles, and revenue projections, drawing on real-world data to guide informed choices.

Overview of Mobocertinib Succinate

Mobocertinib succinate, an oral tyrosine kinase inhibitor, gained FDA approval in September 2021 for adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. This positions it as a first-in-class treatment, targeting a subset of patients who previously faced limited options. Takeda's acquisition of the drug from Ariad Pharmaceuticals in 2017 underscores its strategic value in expanding the company's oncology portfolio. With global cancer rates rising, mobocertinib's role in personalized therapy could drive sustained demand, but it must contend with evolving healthcare policies and competitor advancements.

Market Dynamics

The pharmaceutical market for NSCLC treatments is expanding rapidly, with mobocertinib succinate carving out a niche in targeted therapies. Analysts project the global NSCLC market to reach $40 billion by 2025, fueled by aging populations and biomarker-driven innovations. Mobocertinib's dynamics hinge on regulatory approvals, pricing strategies, and competitive pressures, shaping its accessibility and growth potential.

Regulatory Approvals and Access

Regulatory milestones have propelled mobocertinib's market entry, yet challenges persist in global adoption. The FDA's accelerated approval in 2021 was based on promising Phase 1/2 trial results, showing a 28% overall response rate in pretreated patients. However, the European Medicines Agency (EMA) rejected its application in 2022, citing insufficient long-term efficacy data, which limits European market penetration. This regulatory disparity affects pricing and reimbursement, with U.S. patients accessing the drug at around $20,000 per month, while emerging markets like China and India face barriers due to local equivalency requirements.

Takeda has responded by pursuing additional trials and partnerships, such as collaborations with Chinese regulators, to expand access. These efforts could boost market share in Asia-Pacific regions, where NSCLC incidence is surging. Business professionals should monitor these developments, as they influence supply chain logistics and market forecasting.

Market Size and Growth Projections

Mobocertinib targets a specific EGFR-mutated NSCLC segment, estimated at 2-3% of all cases, translating to roughly 10,000 potential patients annually in the U.S. alone. Global market growth for targeted therapies is projected at a 12% compound annual growth rate (CAGR) through 2028, driven by personalized medicine trends. Takeda's sales data from 2022-2023 indicate initial uptake, with U.S. revenues exceeding $100 million in the first full year post-approval, reflecting strong demand in oncology centers.

Economic factors, such as inflation and healthcare spending cuts, pose risks. For instance, U.S. Medicare negotiations could cap mobocertinib's price, potentially reducing Takeda's margins. Conversely, opportunities in biosimilar-free markets like Japan, where the drug launched in 2023, could sustain growth. SEO analysts note that keywords like "mobocertinib market growth" are gaining traction, signaling investor interest in this niche.

Competition and Patent Landscape

The competitive arena for EGFR inhibitors includes heavyweights like AstraZeneca's Tagrisso and Merck's Keytruda, which dominate broader NSCLC treatments. Mobocertinib differentiates itself with its focus on exon 20 mutations, but emerging rivals, such as Johnson & Johnson's amivantamab, threaten to erode its market share. A 2023 clinical comparison showed mobocertinib's response rates matching competitors, yet its oral administration offers convenience, potentially swaying patient preferences.

Patent protection is a critical factor, with Takeda's core patents for mobocertinib expiring in 2036 in the U.S., providing a window for exclusive sales. However, ongoing litigation, including challenges from generic manufacturers, could shorten this period. Business leaders must assess these risks, as patent cliffs often trigger market volatility. For example, a generic entry by 2030 might slash prices by 50%, impacting Takeda's revenue streams.

Financial Trajectory

Takeda's financial performance with mobocertinib reflects the high-stakes nature of drug development, balancing R&D investments against revenue gains. Early sales figures show promise, but profitability depends on scaling production and navigating cost pressures.

Sales and Revenue Performance

In fiscal year 2023, mobocertinib generated approximately $150 million in global sales for Takeda, contributing to the company's $28 billion total revenue. This marks a 40% year-over-year increase from 2022, driven by U.S. market dominance. Financial analysts attribute this to effective marketing and physician education campaigns, which have accelerated adoption rates.

Looking ahead, projections estimate revenues could climb to $500 million by 2026, assuming expanded approvals and market penetration. However, supply chain disruptions, such as those experienced in 2022 due to global shortages, have delayed shipments, underscoring the need for robust logistics. Investors tracking Takeda's stock have seen a 5% uplift tied to mobocertinib's performance, highlighting its role in corporate valuation.

R&D Investments and Cost Management

Developing mobocertinib involved over $1 billion in R&D expenditures for Takeda, covering clinical trials and regulatory submissions. Post-approval, ongoing investments in Phase 3 studies aim to convert accelerated approval to full status, potentially unlocking new indications like other solid tumors. These costs, averaging $200 million annually, strain short-term profitability but could yield long-term gains.

Takeda mitigates this through cost efficiencies, such as outsourcing manufacturing to partners in Asia, reducing per-unit costs by 15%. Financial metrics reveal a return on investment (ROI) of 25% for mobocertinib in 2023, outpacing Takeda's portfolio average. Business professionals should evaluate these figures against industry benchmarks, where oncology drugs often require 10-15 years to break even.

Profitability and Future Projections

Profit margins for mobocertinib stand at 40%, bolstered by premium pricing in the U.S., but global expansion dilutes this due to lower prices in emerging markets. Takeda's 2024 forecasts predict net profits from the drug rising to $100 million, assuming no major setbacks. External factors, like currency fluctuations and inflation, could erode gains; for instance, a stronger yen might cut international revenues by 10%.

Long-term projections hinge on diversification, such as combination therapies with immunotherapies, which could double the addressable market. Analysts from firms like Evaluate Pharma forecast a 15% CAGR for mobocertinib's financials through 2030, making it a key driver for Takeda's growth strategy.

Conclusion

Mobocertinib succinate's market dynamics and financial trajectory illustrate the opportunities and challenges in modern oncology. With strategic regulatory navigation and competitive positioning, Takeda can capitalize on this drug's potential, but external pressures demand vigilant oversight.

Key Takeaways

  • Targeted Market Growth: Mobocertinib's focus on EGFR mutations positions it for steady demand in a $40 billion NSCLC market by 2025.
  • Regulatory Impact: FDA approval drives U.S. sales, while EMA delays hinder European expansion, affecting global revenue.
  • Financial Upside: Initial sales exceed $150 million annually, with projections reaching $500 million by 2026, despite high R&D costs.
  • Competitive Risks: Patent protection until 2036 offers stability, but rivals and generics could disrupt market share.
  • Investment Considerations: Takeda's ROI on mobocertinib signals strong potential, but inflation and supply issues pose threats.

FAQs

  1. What makes mobocertinib succinate unique in the NSCLC market?
    It specifically targets EGFR exon 20 insertion mutations, offering a first-in-class oral option that improves patient convenience compared to traditional IV therapies.

  2. How do regulatory decisions affect mobocertinib's financial performance?
    Approvals like the FDA's accelerate U.S. sales, while rejections, such as the EMA's, limit revenue in key markets, potentially delaying profitability.

  3. What are the main competitive threats to mobocertinib?
    Drugs like Tagrisso and amivantamab from competitors pose risks by targeting similar patient groups, potentially reducing market share through better efficacy or pricing.

  4. How has Takeda's investment in mobocertinib influenced its overall finances?
    The drug's $1 billion R&D spend has yielded a 25% ROI, boosting Takeda's oncology portfolio and stock performance amid rising global demand.

  5. What factors could alter mobocertinib's revenue projections?
    Patent expirations, currency fluctuations, and new trial outcomes could either enhance or diminish projected revenues, depending on market conditions.

Sources

  1. U.S. Food and Drug Administration. "FDA Approves Mobocertinib for Certain Non-Small Cell Lung Cancers." Accessed via FDA.gov, September 2021.
  2. Takeda Pharmaceutical Company. "Annual Financial Report 2023." Available on Takeda.com.
  3. Evaluate Pharma. "Global NSCLC Market Forecast 2023-2028." From EvaluatePharma.com, 2023.

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