RETEVMO Drug Patent Profile

Which patents cover Retevmo, 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

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.

This potential generic entry date is based on patent 10,112,942.

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	10,137,124*PED				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	10,112,942*PED				Y
Eli Lilly And Co	RETEVMO	selpercatinib	TABLET;ORAL	218160-002	Apr 10, 2024		RX	Yes	No

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

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
Cyprus	1125606
Taiwan	202410896	Formulations of 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile
China	110382494	经取代的吡唑并[1,5-A]吡啶化合物作为RET激酶抑制剂 (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Cyprus	1123201
Japan	7311654
Japan	2022116161	６－（２－ヒドロキシ－２－メチルプロポキシ）－４－（６－（６－（（６－メトキシピリジン－３－イル）メチル）－３，６－ジアザビシクロ［３．１．１］ヘプタン－３－イル）ピリジン－３－イル）ピラゾロ［１，５－Ａ］ピリジン－３－カルボニトリルを含む製剤

Investment Scenario and Fundamentals Analysis for RETEVMO (Selpercatinib)

Last updated: February 20, 2026

What is the current market position of RETEVMO?

RETEVMO (selpercatinib) is a targeted kinase inhibitor approved for RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid carcinoma (MTC), and RET fusion-positive thyroid cancers. It was developed by Eli Lilly and received FDA approval in May 2020, with subsequent approvals in Europe and Japan.

Key financials and market opportunities

Revenue streams

• Initial sales momentum: Since launching in 2020, RETEVMO has recorded strong initial revenues, driven primarily by U.S. approvals and expanding indications.
• Market size estimates:
  • RET fusion-positive NSCLC: Estimated prevalence of 1-2% in NSCLC; global market roughly $500 million.
  • RET-mutant MTC: Rare, with an estimated global patient pool of fewer than 4,000 annually.
  • Thyroid cancers: Small patient populations, but high unmet need.

Market penetration and launch dynamics

Year	Estimated U.S. Sales (USD Million)	Global Sales (USD Million)	Key Factors
2020	50	70	Limited approvals in select indications
2021	150	250	Expanded indications, growing clinical acceptance
2022	350	500	Increased referral, competition from off-label use

Competitive landscape

• Lenvima (Eisai): Also approved for RET MTC; competes indirectly.
• Other RET inhibitors: Kabisatnib, pralsetinib—both in development or approval, creating potential competition.
• Market share: RETEVMO holds an early lead due to FDA approval and fast onboarding.

R&D and pipeline prospects

• Expansion of indications: Trials for RET fusion-positive solid tumors, including lung, thyroid, and other cancers.
• Combination therapies: Studies with immunotherapies and chemotherapies could increase usage.
• Next-generation formulations: Potential for oral bioavailability improvements or combo drugs.

Manufacturing and regulatory outlook

• Manufacturing: Eli Lilly's scale supports anticipated demand growth; no notable supply constraints recorded.
• Regulatory updates: Fast-track designations in some jurisdictions for additional indications; ongoing EMA and Japan approvals.

Investment risks

• Competitive pressures: Entry of new RET inhibitors and biosimilars.
• Regulatory hurdles: Delays in expanding indications could cap revenue.
• Market adoption: Off-label use and physician comfort influence uptake.

Financial outlook

Year	Revenue Projections (USD Million)	Growth Rate	Key Assumptions
2023	650	30%	Continued expansion in indications and market access
2024	950	45%	Broader global rollout, new trial results positive
2025	1,400	47%	Additional approvals, increased physician awareness

Valuation considerations

• Market potential: Approximate peak sales could reach $2 billion globally.
• Pricing: Premium pricing due to targeting rare indications.
• Margins: High R&D and marketing costs initially, but margins expected to improve as sales stabilize.

Key Takeaways

• RETEVMO exhibits rapid initial growth driven by expanding indications and early approval advantages.
• Competition and market penetration barriers present risks.
• Long-term success hinges on successful pipeline expansion and regulatory approvals.
• The drug's niche status in rare tumors supports premium pricing but limits total addressable market size.
• Eli Lilly's manufacturing capacity and global strategy are strong positives.

FAQs

1. What are the primary indications for RETEVMO?
RET fusion-positive NSCLC, RET-mutant medullary thyroid carcinoma, and RET fusion-positive thyroid cancers.

2. How does RETEVMO compare to competitors?
It advantages from early market entry but faces competition from pralsetinib and off-label use of other TKIs.

3. What are the key risks for investors?
Delays in new indications approval, price erosion from competition, and off-label prescribing affecting market share.

4. Which markets show the most growth potential?
The U.S. leads sales, but Japan and Europe are expanding rapidly with further indication approvals.

5. What is the current pipeline status?
Clinical trials are ongoing for other RET-driven cancers and combination therapies, with potential for significant future revenue.

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References

1. Eli Lilly. (2022). RETEVMO (selpercatinib) label.
2. GlobalData. (2023). RET inhibitors market forecast.
3. U.S. FDA. (2020). Approval of RETEVMO for RET fusion-positive NSCLC.
4. ClinicalTrials.gov. (2023). Ongoing trials for RET-targeted therapies.
5. EvaluatePharma. (2023). Top selling oncology drugs and pipeline analysis.