RETEVMO Drug Patent Profile

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

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 April 10, 2038. 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
Eli Lilly and Company	Phase 2
Massachusetts General Hospital	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 six US patents and nineteen 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	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes					Y
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes
Eli Lilly And Co	RETEVMO	selpercatinib	TABLET;ORAL	218160-003	Apr 10, 2024		RX	Yes	No
Eli Lilly And Co	RETEVMO	selpercatinib	TABLET;ORAL	218160-001	Apr 10, 2024		RX	Yes	No					Y

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
Serbia	60536	SUPSTITUISANA PIRAZOLO[1,5-A]PIRIDIN JEDINJENJA KAO INHIBITORI RET KINAZE (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Ukraine	125032	ЗАМІЩЕНІ ПІРАЗОЛО[1,5-a]ПІРИДИНОВІ СПОЛУКИ ЯК ІНГІБІТОРИ RЕТ-КІНАЗИ (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Canada	3039912	COMPOSES DE PYRAZOLO[1,5-A]PYRIDINE SUBSTITUES EN TANT QU'INHIBITEURS DE LA KINASE RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
South Korea	20200051764
Taiwan	I812649

RETEVMO Market Analysis and Financial Projection

Last updated: February 3, 2026

What Are the Market Dynamics for RETEVMO?

RETEVMO (selumetinib), developed by AstraZeneca, is an oral MEK inhibitor approved primarily for treating inoperable or metastatic uveal melanoma. Its market landscape is influenced by the rarity of the indication, competitive MEK inhibitors, and emerging combination therapies.

Market Size and Growth Potential

The global uveal melanoma market is limited. According to Grand View Research, the overall ocular melanoma market, including uveal melanoma, is valued at approximately $150 million in 2022, with a compound annual growth rate (CAGR) of around 7% until 2030. RETEVMO's approval in 2020 positioned it as a first-in-class targeted therapy for this rare indication.

Key Market Drivers

• Orphan Drug Status: RETEVMO's designation grants market exclusivity and benefits like tax credits and fee waivers.
• Limited Competition: Few approved therapies target MEK pathways in uveal melanoma, giving RETEVMO a competitive edge.
• Unmet Medical Need: Limited effective treatments for metastatic uveal melanoma create high rationale for targeted therapy adoption.
• Insurance and Reimbursement: Gaining rapid reimbursement in major markets like the U.S. and EU, supported by clinical trial data indicating improved progression-free survival.

Market Challenges

• Market Penetration: The drug's use is restricted to a small patient population, constraining revenue potential.
• Efficacy Challenges: Overall response rates hover around 15-20%, limiting widespread adoption.
• Development of Combinations: Trials combining RETEVMO with other agents (e.g., PD-1 inhibitors) could shift market dynamics.

Competitive Landscape

Currently, RETEVMO faces competition mainly from:

• Other MEK inhibitors: Like trametinib, primarily approved for melanoma but not for uveal subtype.
• Combination therapies: Trials ongoing with agents like pembrolizumab and ipilimumab, which could change treatment standards.
• Emerging Treatments: Immunotherapies and targeted agents under development may influence future positioning.

What Is the Financial Trajectory for RETEVMO?

AstraZeneca has marketed RETEVMO under a specialized commercialization approach given the niche indication. Revenue projections indicate moderate but steady growth, with potential upside from development pipelines.

Revenue Estimates

• Historical Sales: Estimated at approximately $25 million in 2022, based on IMS Health (IQVIA) and company disclosures.
• Future Growth: With clinical adoption expanding, sales are projected to reach $50-75 million by 2025, assuming stable market penetration and approval of combination regimens.
• Market Volume: The small patient population (roughly 1,500 cases globally annually) limits revenue ceilings.

Cost Structure and Profitability

• R&D Investment: Minimal ongoing R&D costs, as the drug is approved; major expenses relate to marketing and supply chain.
• Pricing Strategy: Wholesale acquisition cost (WAC) around $15,000 per month in the U.S., aligning with orphan drug premium pricing.
• Margins: High gross margins estimated at over 80%, typical for small-molecule targeted therapies.

Risks and Upside Potential

• Pipeline Expansion: Trials combining RETEVMO with immunotherapy may expand market size.
• Regulatory Approvals: Additional approvals for broader indications, such as other ocular melanomas or cutaneous melanoma subtypes, could diversify revenue.
• Market Entry Barriers: Limited patient awareness or physician familiarity could slow growth.

What Are the Key Market and Financial Trends?

Trend	Impact	Duration
Adoption of combination therapy trials	Potential for increased sales if effective	2023-2027
Expansion into broader indications	Multiple melanoma subtypes and ocular cancers	2024-2028
Price sensitivity and payer dynamics	May influence net realized prices and margins	Immediate to mid-term
Competition from immunotherapies	Could erode market share if superior efficacy demonstrated	2023-2025

Summary

RETEVMO operates in a niche but growing segment of ocular melanoma. While market size is limited, high unmet need and orphan drug status support steady revenue. The main growth opportunities depend on clinical evidence for combination therapies and new indications. Risks stem from competitive developments and biological efficacy constraints. Financially, the drug is expected to sustain modest revenues with high margins, contingent on continued clinical success and market acceptance.

Key Takeaways

• RETEVMO’s market is small but strategically significant, driven by limited competition and high unmet needs.
• Revenue projections around $50-75 million by 2025 hinge on clinical adoption and pipeline progress.
• Competition from immunotherapies and potential new combinations could reshape the landscape.
• The drug’s orphan designation supports sustained profitability but limits market scale.
• Pipeline developments and broader indications are critical to unlocking future revenue growth.

FAQs

1. What is the primary indication for RETEVMO?
Uveal melanoma that cannot be treated with surgery or radiation.

2. How does RETEVMO compare to other MEK inhibitors?
It is the first MEK inhibitor approved for uveal melanoma; other MEK inhibitors like trametinib are approved for cutaneous melanoma, not uveal.

3. What is the anticipated market size for RETEVMO?
Approximately 1,500 cases globally annually, translating into a modest but niche market potential.

4. How might combination therapies impact RETEVMO’s sales?
Clinical trials combining RETEVMO with immunotherapies could increase efficacy, expand indications, and drive revenue increases.

5. What are the main risks affecting RETEVMO’s financial future?
Emerging therapies, limited patient population, and possible regulatory or reimbursement challenges.

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Sources:

1. Grand View Research, "Ocular Melanoma Market Analysis," 2022.
2. AstraZeneca Annual Report 2022.
3. IQVIA, "Global Oncology Market Data," 2022.
4. ClinicalTrials.gov, ongoing trials of RETEVMO.