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Last Updated: December 22, 2024

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RETEVMO Drug Patent Profile


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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

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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: 45
Drug Prices: Drug price information for RETEVMO
What excipients (inactive ingredients) are in RETEVMO?RETEVMO excipients list
DailyMed Link:RETEVMO at DailyMed
Drug patent expirations by year for RETEVMO
Drug Prices for RETEVMO

See drug prices for RETEVMO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RETEVMO
Generic Entry Dates for RETEVMO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for RETEVMO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Massachusetts General HospitalPhase 2
Eli Lilly and CompanyPhase 2
Southwest Oncology GroupPhase 2

See all RETEVMO clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RETEVMO is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Loxo Oncol Eli Lilly RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Loxo Oncol Eli Lilly RETEVMO selpercatinib TABLET;ORAL 218160-001 Apr 10, 2024 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 9919
Patent: COMPUESTOS PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDA COMO INHIBIDORES DE RET QUINASA
Estimated Expiration: ⤷  Subscribe

Patent: 9920
Patent: COMPUESTOS PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDA COMO INHIBIDORES DE RET QUINASA
Estimated Expiration: ⤷  Subscribe

Patent: 3760
Patent: FORMAS CRISTALINAS
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 17342022
Patent: Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Estimated Expiration: ⤷  Subscribe

Patent: 17342027
Patent: Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Estimated Expiration: ⤷  Subscribe

Patent: 18348161
Patent: Crystalline forms
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2019007143
Patent: compostos de pirazolo[1,5-a]piridina substituídos como inibidores da ret cinase
Estimated Expiration: ⤷  Subscribe

Patent: 2019007144
Patent: compostos de pirazolo[1,5-a]piridina substituídos como inibidores da ret cinase
Estimated Expiration: ⤷  Subscribe

Patent: 2020005463
Patent: formas cristalinas
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 39760
Patent: COMPOSES SUBSTITUES DE PYRAZOLO[1,5-A]PYRIDINE EN TANT QU'INHIBITEURS DE LA KINASE RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 39912
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 79012
Patent: FORMES CRISTALLINES (CRYSTALLINE FORMS)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 19000941
Patent: Compuestos de pirazolo[1,5-a]piridina sustituidos como inhibidores de la quinasa ret.
Estimated Expiration: ⤷  Subscribe

Patent: 19000942
Patent: Compuestos de pirazolo[1,5-a]piridina sustituidos como inhibidores de la quinasa ret.
Estimated Expiration: ⤷  Subscribe

China

Patent: 0177786
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 0382494
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 1278822
Patent: 结晶形式 (CRYSTALLINE FORMS)
Estimated Expiration: ⤷  Subscribe

Patent: 4163437
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 19004649
Patent: Compuestos de pirazolo[1,5-a]piridina sustituidos como inhibidores de la quinasa ret
Estimated Expiration: ⤷  Subscribe

Patent: 19004650
Patent: Compuestos de pirazolo[1,5-a]piridina sustituidos como inhibidores de la quinasa ret
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 190218
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 190224
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0201008
Estimated Expiration: ⤷  Subscribe

Patent: 0221154
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 23201
Estimated Expiration: ⤷  Subscribe

Patent: 25606
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 23301
Estimated Expiration: ⤷  Subscribe

Patent: 23302
Estimated Expiration: ⤷  Subscribe

Dominican Republic

Patent: 019000090
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET
Estimated Expiration: ⤷  Subscribe

Patent: 019000091
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 19032676
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET
Estimated Expiration: ⤷  Subscribe

Patent: 19033052
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 5568
Patent: ЗАМЕЩЕННЫЕ ПИРАЗОЛО[1,5-а]ПИРИДИНОВЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ RET КИНАЗЫ (SUBSTITUTED PYRAZOLO[1,5-a]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 7208
Patent: ЗАМЕЩЕННЫЕ ПИРАЗОЛО[1,5-а]ПИРИДИНОВЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ RET КИНАЗЫ (SUBSTITUTED PYRAZOLO[1,5-a]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 1990939
Patent: ЗАМЕЩЕННЫЕ ПИРАЗОЛО[1,5-a]ПИРИДИНОВЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ RET КИНАЗЫ
Estimated Expiration: ⤷  Subscribe

Patent: 1990940
Patent: ЗАМЕЩЕННЫЕ ПИРАЗОЛО[1,5-a]ПИРИДИНОВЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ RET КИНАЗЫ
Estimated Expiration: ⤷  Subscribe

Patent: 2090695
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 23301
Patent: COMPOSÉS SUBSTITUÉS DE PYRAZOLO[1,5-A]PYRIDINE EN TANT QU'INHIBITEURS DE LA KINASE RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 23302
Patent: COMPOSÉS DE PYRAZOLO[1,5-A]PYRIDINE SUBSTITUÉS EN TANT QU'INHIBITEURS DE LA KINASE RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 94854
Patent: FORMES CRISTALLINES (CRYSTALLINE FORMS)
Estimated Expiration: ⤷  Subscribe

Patent: 53939
Patent: COMPOSÉS SUBSTITUÉS DE PYRAZOLO[1,5-A]PYRIDINE EN TANT QU'INHIBITEURS DE LA KINASE RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 44735
Patent: COMPOSÉS DE PYRAZOLO[1,5-A]PYRIDINE SUBSTITUÉS EN TANT QU'INHIBITEURS DE LA KINASE RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 51424
Estimated Expiration: ⤷  Subscribe

Patent: 60089
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 5916
Patent: תרכובות פיראזולו[1,5-a]פירידין מותמר כמעכבי ret קינאז (Substituted pyrazolo[1,5-a]pyridine compounds as ret kinase inhibitors)
Estimated Expiration: ⤷  Subscribe

Patent: 5918
Patent: תרכובות פיראזולו[1,5-a]פירידין מותמר כמעכבי ret קינאז (Substituted pyrazolo[1,5-a]pyridine compounds as ret kinase inhibitors)
Estimated Expiration: ⤷  Subscribe

Patent: 3730
Patent: צורות גבישיות (Crystalline forms)
Estimated Expiration: ⤷  Subscribe

Patent: 7576
Patent: תרכובות פיראזולו[1,5-a]פירידין מותמר כמעכבי ret קינאז (Substituted pyrazolo[1,5-a]pyridine compounds as ret kinase inhibitors)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 76446
Estimated Expiration: ⤷  Subscribe

Patent: 45070
Estimated Expiration: ⤷  Subscribe

Patent: 75399
Estimated Expiration: ⤷  Subscribe

Patent: 79303
Estimated Expiration: ⤷  Subscribe

Patent: 11654
Estimated Expiration: ⤷  Subscribe

Patent: 02365
Estimated Expiration: ⤷  Subscribe

Patent: 19533670
Patent: RETキナーゼ阻害剤としての置換ピラゾロ[1,5−A]ピリジン化合物
Estimated Expiration: ⤷  Subscribe

Patent: 20503247
Patent: RETキナーゼ阻害剤としての置換ピラゾロ[1,5−A]ピリジン化合物
Estimated Expiration: ⤷  Subscribe

Patent: 20536900
Patent: 結晶形態
Estimated Expiration: ⤷  Subscribe

Patent: 21035944
Patent: RETキナーゼ阻害剤としての置換ピラゾロ[1,5−A]ピリジン化合物 (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 22062168
Patent: RETキナーゼ阻害剤としての置換ピラゾロ[1,5-A]ピリジン化合物
Estimated Expiration: ⤷  Subscribe

Patent: 22116108
Patent: RETキナーゼ阻害剤としての置換ピラゾロ[1,5-A]ピリジン化合物
Estimated Expiration: ⤷  Subscribe

Patent: 23134580
Patent: RETキナーゼ阻害剤としての置換ピラゾロ[1,5-A]ピリジン化合物 (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Jordan

Patent: 0190076
Patent: مركبات بيرازولو [1، 5-A]بيريدين بها استبدال كمثبطات كيناز RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 0190077
Patent: مركبات بيرازولو [1، 5-A]بيريدين بها استبدال كمثبطات كيناز RET (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 23301
Estimated Expiration: ⤷  Subscribe

Patent: 23302
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 5573
Patent: SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 19004204
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET. (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS.)
Estimated Expiration: ⤷  Subscribe

Patent: 19004205
Patent: COMPUESTOS DE PIRAZOLO[1,5-4]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET. (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS.)
Estimated Expiration: ⤷  Subscribe

Patent: 20003552
Patent: FORMAS CRISTALINAS. (CRYSTALLINE FORMS.)
Estimated Expiration: ⤷  Subscribe

Patent: 20011250
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET. (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS.)
Estimated Expiration: ⤷  Subscribe

Moldova, Republic of

Patent: 23301
Estimated Expiration: ⤷  Subscribe

Patent: 23302
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 462
Patent: Composés substitués de pyrazolo[1,5-a]pyridine en tant qu'inhibiteurs de la kinase ret
Estimated Expiration: ⤷  Subscribe

Patent: 463
Patent: COMPOSÉS DE PYRAZOLO[1,5-A]PYRIDINE SUBSTITUÉS EN TANT QU'INHIBITEURS DE LA KINASE RET
Estimated Expiration: ⤷  Subscribe

Patent: 675
Patent: COMPOSÉS SUBSTITUÉS DE PYRAZOLO[1,5-A]PYRIDINE EN TANT QU'INHIBITEURS DE LA KINASE RET
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 2793
Patent: Substituted pyrazolo[1,5-a]pyridine compounds as ret kinase inhibitors
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 190918
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET
Estimated Expiration: ⤷  Subscribe

Patent: 191613
Patent: COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 019500775
Patent: SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Patent: 019500776
Patent: SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 23301
Estimated Expiration: ⤷  Subscribe

Patent: 23302
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 23301
Estimated Expiration: ⤷  Subscribe

Patent: 23302
Estimated Expiration: ⤷  Subscribe

Saudi Arabia

Patent: 9401541
Patent: [1، 5-A] مركبات بيرازولو كيناز RET بيريدين بها استبدال كمثبطات (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 9401544
Patent: [1، 5-A] مركبات بيرازولو بيريدين بها استبدال كمثبطات كيناز معاد ترتيبه أثناء نقل العدوى (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS REARRANGED DURING TRANSFECTION KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 536
Patent: SUPSTITUISANA PIRAZOLO[1,5-A]PIRIDIN JEDINJENJA KAO INHIBITORI RET KINAZE (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 510
Patent: SUPSTITUISANA PIRAZOLO[1,5-A]PIRIDIN JEDINJENJA KAO INHIBITORI RET KINAZE (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201903144P
Patent: SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Patent: 201903187W
Patent: SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 23301
Estimated Expiration: ⤷  Subscribe

Patent: 23302
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 2004040
Patent: SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2143899
Estimated Expiration: ⤷  Subscribe

Patent: 2287752
Estimated Expiration: ⤷  Subscribe

Patent: 2410437
Estimated Expiration: ⤷  Subscribe

Patent: 190076976
Patent: RET 키나제 억제제로서의 치환된 피라졸로[1,5-A]피리딘 화합물
Estimated Expiration: ⤷  Subscribe

Patent: 190077389
Patent: RET 키나제 억제제로서의 치환된 피라졸로[1,5-A]피리딘 화합물
Estimated Expiration: ⤷  Subscribe

Patent: 200051744
Patent: 결정질 형태
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 05087
Estimated Expiration: ⤷  Subscribe

Patent: 26136
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 04148
Estimated Expiration: ⤷  Subscribe

Patent: 52098
Estimated Expiration: ⤷  Subscribe

Patent: 91053
Estimated Expiration: ⤷  Subscribe

Patent: 1825488
Patent: Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Estimated Expiration: ⤷  Subscribe

Patent: 1827428
Patent: Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Estimated Expiration: ⤷  Subscribe

Patent: 1922741
Patent: Crystalline forms
Estimated Expiration: ⤷  Subscribe

Tunisia

Patent: 19000107
Patent: SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Patent: 19000110
Patent: SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 5030
Patent: ЗАМІЩЕНІ ПІРАЗОЛО[1,5-a]ПІРИДИНОВІ СПОЛУКИ ЯК ІНГІБІТОРИ RET-КІНАЗИ (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 5032
Patent: ЗАМІЩЕНІ ПІРАЗОЛО[1,5-a]ПІРИДИНОВІ СПОЛУКИ ЯК ІНГІБІТОРИ RЕТ-КІНАЗИ (SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Uruguay

Patent: 925
Patent: FORMAS CRISTALINAS
Estimated Expiration: ⤷  Subscribe

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
Singapore 11201903187W SUBSTITUTED PYRAZOLO[1,5-A]PYRIDINE COMPOUNDS AS RET KINASE INHIBITORS ⤷  Subscribe
Japan 2020503247 RETキナーゼ阻害剤としての置換ピラゾロ[1,5−A]ピリジン化合物 ⤷  Subscribe
Chile 2019000942 ⤷  Subscribe
Eurasian Patent Organization 202090695 КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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 ...

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