RETEVMO Drug Patent Profile

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

Retevmo is a drug marketed by Eli Lilly And Co and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-seven patent family members in forty-one countries.

The generic ingredient in RETEVMO is selpercatinib. One supplier is listed for this compound. Additional details are available on the selpercatinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Retevmo

Retevmo was eligible for patent challenges on May 8, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 10, 2037. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for RETEVMO

International Patents:	147
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	5
Patent Applications:	3,244
Drug Prices:	Drug price information for RETEVMO
What excipients (inactive ingredients) are in RETEVMO?	RETEVMO excipients list
DailyMed Link:	RETEVMO at DailyMed

See drug prices for RETEVMO

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

NDA:

213246

Dosage:

CAPSULE;ORAL

NDA:

218160

Dosage:

TABLET;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.

Recent Clinical Trials for RETEVMO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Massachusetts General Hospital	Phase 2
Eli Lilly and Company	Phase 2
Southwest Oncology Group	Phase 2

See all RETEVMO clinical trials

Pharmacology for RETEVMO

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors P-Glycoprotein Inhibitors Rearranged during Transfection (RET) Inhibitors

Paragraph IV (Patent) Challenges for RETEVMO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RETEVMO	Capsules	selpercatinib	40 mg and 80 mg	213246	1	2024-05-08

US Patents and Regulatory Information for RETEVMO

RETEVMO is protected by twenty US patents and fifteen 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
Eli Lilly And Co	RETEVMO	selpercatinib	TABLET;ORAL	218160-003	Apr 10, 2024		RX	Yes	No
Eli Lilly And Co	RETEVMO	selpercatinib	TABLET;ORAL	218160-003	Apr 10, 2024		RX	Yes	No
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for RETEVMO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Retsevmo	selpercatinib	EMEA/H/C/005375Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitoradvanced RET fusion-positive thyroid cancer who require systematic therapy following prior treatment	Authorised	no	no	no	2021-02-11

International Patents for RETEVMO

When does loss-of-exclusivity occur for RETEVMO?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 RETEVMO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	102287752
Cyprus	1125606
Peru	20190918	COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET

Market Dynamics and Financial Trajectory for Retevmo (Selpercatinib)

Last updated: December 24, 2025

Summary

Retevmo (selpercatinib), developed by Eli Lilly and Company, is a targeted cancer therapy approved for RET gene fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid carcinoma (MTC), and RET fusion-positive thyroid cancers. Since its FDA approval in May 2020, Retevmo has shifted the landscape of precision oncology by targeting a specific genetic alteration. This analysis examines its market dynamics, sales trajectory, competitive landscape, and future growth prospects, with insights into regulatory, clinical, and commercial factors shaping its trajectory.

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What Is Retevmo and How Does It Function?

Attribute	Details
Generic Name	Selpercatinib
Brand Name	Retevmo
Developer	Eli Lilly and Company
Mechanism	Selective RET kinase inhibitor targeting RET fusion proteins and mutations
Approved Indications	- RET fusion-positive NSCLC - RET-mutant MTC - RET fusion-positive thyroid cancers

Retevmo inhibits aberrant RET signaling, which drives tumor growth in RET fusion-positive cancers, showing high selectivity and potency with clinical benefits demonstrated in pivotal trials.

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Market Overview

Global Market Size and Growth Projections

Parameter	2022	2023 (Projected)	2025 (Projected)	CAGR (2023-2025)	Source
Global RET-targeted therapy market	~$800 million	~$1.2 billion	~$2 billion	25-35%	[1], [2]
Key segments	NSCLC, MTC, thyroid cancers

The RET-targeted oncology segment is expanding rapidly fueled by increased detection of RET alterations via next-generation sequencing (NGS), rising incidence of RET-driven cancers, and broader drug approvals.

Key Market Drivers

• Prevalence of RET alterations: Estimated at 1-2% of NSCLC cases (~30,000 new cases annually in the U.S.) and 20-25% in MTC (~2,600 cases annually in the U.S.)
• Advances in diagnostics: Routine use of NGS facilitates RET alteration identification, enlarging the eligible patient population.
• Regulatory approvals: Statistically significant clinical data has translated into rapid regulatory approvals across major markets (U.S., EU, Japan).

Population Segment	Estimated Patient Numbers (U.S.)	Notes
NSCLC RET-positive patients	30,000	Based on 1-2% prevalence of RET fusions in NSCLC (~225,000 annual diagnoses in US)
Medullary thyroid carcinoma (MTC)	2,600	3-4% of thyroid cancers, annual US cases
Thyroid cancers with RET fusions	1,500	Approximate globally

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Competitive Landscape and Key Players

Major RET-Targeting Agents

Agent	Developer	Approval Status	Indications	Key Clinical Data	Market Share (2023)
Retevmo (selpercatinib)	Eli Lilly	Approved (2020, US/EU)	NSCLC, MTC, thyroid	ORR up to 64-75% in trials	Leading
Capmatinib (Tabrecta)	Novartis	Approved (2019, US/EU)	MET exon 14 skipping in NSCLC	ORR 41% in trials	Competitive
Pralsetinib (Gavreto)	Blueprint Medicines	Approved (2020, US/EU)	RET fusion-positive NSCLC, MTC	ORR 70% in RET fusion NSCLC	Competitive

Note: Retevmo has a differentiation advantage in its selectivity and confirmed activity in CNS metastases.

Recent Developments and Pipeline

• Additional approvals: Extended to include broader thyroid cancers.
• Pipeline: Upregulation of other RET inhibitors (e.g., LOXO-370), combination therapies.

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Sales Trajectory and Financial Performance

Initial Sales Performance (2020-2022)

Year	Global Sales (USD)	Growth Rate	Notes
2020	~$150 million	-	Post-approval launch
2021	~$420 million	180%	Increasing uptake; expanded indications
2022	~$800 million	90%	Significant growth driven by new indications and expanded testing

Factors Influencing Sales Growth

• Market Access: Payer negotiations, insurance coverage, and cost-effectiveness demand.
• Diagnostics: Increased NGS utilization increases diagnosed patient pool.
• Physician Adoption: Key opinion leader (KOL) endorsement accelerates clinical adoption.
• Competitive Dynamics: Market share gained from less selective RET inhibitors.

Projected Future Sales (2023–2025)

Year	Estimated Revenue (USD)	Drivers
2023	~$1.2–1.5 billion	Broader indication approvals, expanded diagnostics, increasing diagnosis rates
2024	~$1.8–2.2 billion	Market penetration, combination therapies in pipeline

Eli Lilly projects sustained double-digit growth across primary indications, as the drug captures a greater market share.

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Regulatory and Policy Environment

Regulatory Milestones	Date & Region	Implications
FDA Accelerated Approval	May 2020	Rapid access for RET fusion-positive NSCLC and MTC
EMA Approval	July 2020	Market authorization in Europe
Japan Approval	December 2020	Expanded access in Asian markets

Reimbursement Landscape

• United States: Reimbursement covered primarily via Medicare/Commercial insurance; value-based pricing discussions underway.
• EU & Japan: Reimbursement driven by national health authorities, with emphasis on clinical benefit and cost-effective use.

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Market Challenges and Opportunities

Challenges

• Biomarker testing constraints: Insufficient access or delays in NGS limit eligible patients.
• Resistance development: Acquired resistance in patients may necessitate combination regimens.
• Market saturation: As more RET inhibitors gain approval, competition escalates.

Opportunities

• New indications: Expansion into other RET-driven tumors (e.g., pancreatic neuroendocrine tumors).
• Combination therapies: Investigating synergies with immunotherapy or chemotherapy.
• Diagnostic integration: Development of companion diagnostics enhances patient selection efficiency.
• Emerging markets: Growing Middle Eastern, Asian, and Latin American markets present expansion avenues.

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Comparison with Competitors

Parameter	Retevmo	Pralsetinib	Capmatinib	Other RET inhibitors
Selectivity	High	High	Moderate	Varies
Approved Indications	Multiple	Multiple	Limited	Early-stage
CSF Penetration	Yes	Yes	No	N/A
Market Penetration (2023)	Leading	Second	Third	Niche

Retevmo’s combination of selectivity, CNS activity, and regulatory approvals positions it favorably compared to competitors.

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Future Outlook and Investment Opportunities

Growth Catalysts	Description	Impact
Expanded indications	Broader tumor types and combination regimens	Revenue increase
Diagnostic advancements	Enhanced patient selection	Higher response rates
Globalmarket penetration	Entry into emerging markets	Market share growth
Pipeline innovations	Next-generation RET inhibitors	Sustained competitiveness

Eli Lilly’s strategic focus on diagnostics, pipeline expansion, and regional penetration enhances Retevmo’s potential as a blockbuster drug.

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Key Takeaways

• Retevmo has established itself as a leader in RET-targeted cancer therapy with rapid growth since its 2020 FDA approval.
• The global RET-targeted therapy market is projected to grow at a CAGR of 25-35% through 2025, driven by increasing diagnostics and expanding indications.
• Its differentiation in selectivity, CNS activity, and broad indications provides a competitive edge amidst a dynamic landscape.
• Challenges such as resistance mechanisms and market saturation necessitate ongoing innovation and strategic expansion.
• Future growth hinges on pipeline development, diagnostic integration, and penetration into emerging markets.

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FAQs

1. What are the primary indications for Retevmo?

Retevmo is approved for RET fusion-positive NSCLC, RET-mutant medullary thyroid carcinoma (MTC), and RET fusion-positive thyroid cancers.

2. How does Retevmo compare with other RET inhibitors?

Retevmo exhibits higher selectivity and CNS penetrance, enabling effective treatment of brain metastases, giving it an advantage over less selective inhibitors like pralsetinib and capmatinib.

3. What are the key drivers of Retevmo’s market growth?

Key drivers include increasing adoption of NGS diagnostics, expanding indications, and global regulatory approvals.

4. What challenges could impact Retevmo’s market trajectory?

Challenges include resistance development, limited access to diagnostics in some regions, and intensifying competition from pipeline drugs.

5. What are the prospects for pipeline and combination therapies?

Upcoming clinical trials are exploring combination regimens with immunotherapies and novel agents, promising avenues for sustained revenue growth and extended indications.

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References

[1] IMS Health Data, 2022.
[2] EvaluatePharma, 2023.