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RETEVMO Drug Patent Profile

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

Retevmo is a drug marketed by Loxo Oncol Eli Lilly and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-five 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:	135
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	5
Patent Applications:	51
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 seventeen US patents and ten 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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	TABLET;ORAL	218160-004	Apr 10, 2024		RX	Yes	Yes
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	TABLET;ORAL	218160-001	Apr 10, 2024		RX	Yes	No
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes				Y
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No

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/005375 Retsevmo 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
Mexico	2019004204
Israel	265916
Israel	273730	צורות גבישיות (Crystalline forms)
Brazil	112020005368	formulações compreendendo 6-(2-hidróxi-2-metilpropóxi)-4-(6-(6-((6-metoxipiridin-3-il)metil)-3,6-diazabiciclo[3.1.1]heptan-3-il) piridin-3-il)pirazolo[1,5-a]piridina-3-carbonitrila
Morocco	46463
Taiwan	201825488	Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Cyprus	1125606

RETEVMO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Retevmo (Selpercatinib)

Introduction to Retevmo

Retevmo, also known as selpercatinib, is a targeted therapy developed by Eli Lilly and Company for the treatment of certain types of cancer, including RET fusion-positive non-small cell lung cancer (NSCLC) and RET-mutant medullary thyroid cancer (MTC). Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Clinical Efficacy and Approval

Retevmo has demonstrated substantial clinical efficacy in treating RET-driven cancers. In the Phase 3 LIBRETTO-431 study, Retevmo more than doubled progression-free survival (PFS) compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic RET fusion-positive NSCLC[3].

For RET-mutant MTC, the LIBRETTO-531 study showed a 72% improvement in PFS compared to cabozantinib or vandetanib[4]. These results have led to traditional FDA approval for adult and pediatric patients with advanced or metastatic RET-mutant MTC, and accelerated approval for RET fusion-positive NSCLC.

Market Impact

Patient Population and Unmet Need

Retevmo addresses a specific but significant patient population with RET-driven cancers, which are often aggressive and have limited treatment options. The drug's approval fills an unmet need, offering patients a more effective and targeted therapy.

Competitive Landscape

In the landscape of targeted therapies for NSCLC and MTC, Retevmo stands out due to its superior PFS and overall response rate (ORR) compared to traditional treatments like chemotherapy plus pembrolizumab and other tyrosine kinase inhibitors such as cabozantinib and vandetanib[3][4].

Financial Performance and Projections

Revenue Contribution

Retevmo is part of Eli Lilly's growing portfolio of new products, which have significantly contributed to the company's revenue growth. While specific revenue figures for Retevmo are not separately disclosed, the overall revenue from new products, including Mounjaro, Verzenio, and Jardiance, has seen a substantial increase. For instance, in Q3 2023, Eli Lilly reported a 37% increase in revenue, driven in part by these new products[5].

Cost and Pricing

The cost of Retevmo is a critical factor in its market dynamics. According to CADTH, the drug is expected to increase public drug plan costs significantly, with estimates ranging from $10.7 million to over $40 million over three years. However, CADTH has suggested that a price reduction is necessary for Retevmo to represent good value to the healthcare system[1].

Research and Development

Eli Lilly has invested heavily in research and development, with a 30% increase in R&D expenses in 2023 compared to the previous year. This investment includes the development and clinical trials of Retevmo, which have been pivotal in its approval and market success[2].

Health Economic Impact

Cost-Benefit Analysis

The health economic impact of Retevmo is complex. While the drug offers significant clinical benefits, its high cost poses a challenge to healthcare systems. CADTH's assessment highlights the need for a price reduction to ensure the drug's value aligns with its cost to the public healthcare system[1].

Patient Outcomes and Quality of Life

Retevmo's clinical efficacy translates into improved patient outcomes and quality of life. Patients treated with Retevmo have reported fewer severe side effects and better overall survival rates compared to traditional treatments, which can significantly impact healthcare resource utilization and patient well-being[3][4].

Regulatory and Expedited Programs

FDA Approvals and Designations

Retevmo has received several favorable designations from the FDA, including traditional approval, accelerated approval, priority review, breakthrough designation, and orphan drug designation. These designations expedite the drug's development and approval process, reflecting its potential to address serious and rare conditions[4].

Safety Profile

Adverse Reactions and Laboratory Abnormalities

The safety profile of Retevmo is generally consistent with other targeted therapies. Common adverse reactions include hypertension, edema, dry mouth, fatigue, and diarrhea. Grade 3 or 4 laboratory abnormalities such as decreased lymphocytes and increased liver enzymes have also been reported[4].

Market Penetration and Adoption

Clinical Guidelines and Recommendations

Retevmo's inclusion in clinical guidelines and recommendations is crucial for its market penetration. Given its superior clinical outcomes, Retevmo is likely to be recommended as a first-line treatment for RET fusion-positive NSCLC and RET-mutant MTC, which will drive its adoption in clinical practice[3].

Physician and Patient Awareness

Awareness among physicians and patients is another key factor. Presentations at major oncology conferences, such as the ESMO Congress, and publications in prestigious journals like The New England Journal of Medicine, help in increasing awareness and acceptance of Retevmo[3].

Future Outlook

Continued Clinical Development

Eli Lilly is likely to continue investing in the clinical development of Retevmo, exploring additional indications and combinations with other therapies. This ongoing development will further solidify Retevmo's position in the market.

Market Expansion

As Retevmo gains more approvals and recommendations, its market is expected to expand globally. The drug's efficacy and safety profile make it a promising candidate for widespread adoption in the treatment of RET-driven cancers.

Key Takeaways

• Clinical Efficacy: Retevmo has demonstrated significant clinical benefits in treating RET fusion-positive NSCLC and RET-mutant MTC.
• Market Impact: The drug addresses an unmet need and stands out in a competitive landscape due to its superior PFS and ORR.
• Financial Performance: Retevmo contributes to Eli Lilly's growing revenue from new products, though its high cost poses challenges to healthcare systems.
• Health Economic Impact: The drug offers improved patient outcomes but requires careful cost-benefit analysis.
• Regulatory Support: Retevmo has received favorable FDA designations, expediting its development and approval.
• Safety Profile: The drug's safety profile is generally consistent with other targeted therapies.

FAQs

Q: What is Retevmo used for?

Retevmo (selpercatinib) is used for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC) and RET-mutant medullary thyroid cancer (MTC).

Q: What are the key clinical benefits of Retevmo?

Retevmo has been shown to more than double progression-free survival (PFS) in patients with RET fusion-positive NSCLC and to improve PFS by 72% in patients with RET-mutant MTC compared to other treatments.

Q: How much does Retevmo cost, and what is its impact on healthcare systems?

Retevmo is expected to increase public drug plan costs significantly, with estimates ranging from $10.7 million to over $40 million over three years. A price reduction is suggested to ensure good value to the healthcare system.

Q: What are the common adverse reactions associated with Retevmo?

Common adverse reactions include hypertension, edema, dry mouth, fatigue, and diarrhea. Grade 3 or 4 laboratory abnormalities such as decreased lymphocytes and increased liver enzymes have also been reported.

Q: Has Retevmo received any special designations from the FDA?

Yes, Retevmo has received traditional approval, accelerated approval, priority review, breakthrough designation, and orphan drug designation from the FDA.

Sources

1. NCBI Bookshelf: Selpercatinib (Retevmo)
2. Eli Lilly Investor Relations: Lilly Reports Strong Fourth-Quarter 2023 Financial Results and ...
3. Eli Lilly Investor Relations: Lilly's Retevmo® (selpercatinib) Phase 3 Results in RET Fusion ...
4. FDA: FDA approves selpercatinib for medullary thyroid cancer with a RET mutation
5. Eli Lilly Investor Relations: Lilly Reports Third-Quarter 2023 Financial Results, Highlights ...