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Last Updated: September 30, 2022

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 Oncology Inc and is included in one NDA. There are five patents protecting this drug.

This drug has seventy-seven patent family members in thirty-six 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 will be eligible for patent challenges on May 8, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 10, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RETEVMO
International Patents:77
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 29
Clinical Trials: 4
Patent Applications: 43
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 Generic Entry Opportunity Date for RETEVMO
Generic Entry Date for RETEVMO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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
Southwest Oncology GroupPhase 2
M.D. Anderson Cancer CenterPhase 2
Children's Oncology GroupPhase 2

See all RETEVMO clinical trials

US Patents and Regulatory Information for RETEVMO

RETEVMO is protected by seventeen US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RETEVMO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RETEVMO

Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY

Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER

Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)

Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER

Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY

Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)

Crystalline forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)

Crystalline forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER

Crystalline forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY

Formulations of 6-(2-hydroxy-2-methylpropxy)-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-carb- onitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY, WHEREIN THE CANCER IS PAPILLARY THYROID CANCER

Formulations of 6-(2-hydroxy-2-methylpropxy)-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-carb- onitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY

Formulations of 6-(2-hydroxy-2-methylpropxy)-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-carb- onitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY, WHEREIN THE CANCER IS RECURRENT THYROID CANCER

Formulations of 6-(2-hydroxy-2-methylpropxy)-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-carb- onitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY, WHEREIN THE CANCER IS MEDULLARY THYROID CANCER

Formulations of 6-(2-hydroxy-2-methylpropxy)-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-carb- onitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)

Formulations of 6-(2-hydroxy-2-methylpropxy)-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-carb- onitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY, WHEREIN THE CANCER IS DIFFERENTIATED THYROID CANCER

Formulations of 6-(2-hydroxy-2-methylpropxy)-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-carb- onitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE REFRACTORY DIFFERENTIATED THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND ARE RADIOACTIVE IODINE-REFRACTORY

FDA Regulatory Exclusivity protecting RETEVMO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: See Plans and Pricing

ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Loxo Oncology Inc RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Loxo Oncology Inc RETEVMO selpercatinib CAPSULE;ORAL 213246-001 May 8, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Loxo Oncology Inc RETEVMO selpercatinib CAPSULE;ORAL 213246-001 May 8, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Loxo Oncology Inc RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Loxo Oncology Inc RETEVMO selpercatinib CAPSULE;ORAL 213246-001 May 8, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Loxo Oncology Inc RETEVMO selpercatinib CAPSULE;ORAL 213246-001 May 8, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Loxo Oncology Inc RETEVMO selpercatinib CAPSULE;ORAL 213246-002 May 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 with:advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapyadvanced RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinibRetsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with cabozantinib and/or vandetanib.
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: 3760
Estimated Expiration: See Plans and Pricing

Australia

Patent: 18348161
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2020005463
Estimated Expiration: See Plans and Pricing

Canada

Patent: 79012
Estimated Expiration: See Plans and Pricing

China

Patent: 1278822
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2090695
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 94854
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3730
Estimated Expiration: See Plans and Pricing

Japan

Patent: 45070
Estimated Expiration: See Plans and Pricing

Patent: 20536900
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2410437
Estimated Expiration: See Plans and Pricing

Patent: 200051744
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1922741
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 925
Estimated Expiration: See Plans and Pricing

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
Israel 265916 תרכובות פיראזולו[1,5-a]פירידין מותמר כמעכבי ret קינאז (Substituted pyrazolo[1,5-a]pyridine compounds as ret kinase inhibitors) See Plans and Pricing
Argentina 113760 FORMAS CRISTALINAS See Plans and Pricing
Israel 273730 צורות גבישיות (Crystalline forms) See Plans and Pricing
Denmark 3523301 See Plans and Pricing
Australia 2018347375 Formulations comprising 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazab icyclo(3.1.1)heptan-3-yl)pyridin-3-yl)pyrazolo(1,5-a)pyridine-3-carbonitrile See Plans and Pricing
Chile 2019000941 Compuestos de pirazolo[1,5-a]piridina sustituidos como inhibidores de la quinasa ret. See Plans and Pricing
Japan 2021035944 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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Boehringer Ingelheim
McKesson
Johnson and Johnson
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.