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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 213246


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NDA 213246 describes RETEVMO, which is a drug marketed by Loxo Oncol Eli Lilly and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the RETEVMO profile page.

The generic ingredient in RETEVMO is selpercatinib. One supplier is listed for this compound. Additional details are available on the selpercatinib profile page.
Summary for 213246
Tradename:RETEVMO
Applicant:Loxo Oncol Eli Lilly
Ingredient:selpercatinib
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213246
Generic Entry Date for 213246*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 213246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETEVMO selpercatinib CAPSULE;ORAL 213246 NDA Eli Lilly and Company 0002-2980 0002-2980-26 120 CAPSULE in 1 BOTTLE (0002-2980-26)
RETEVMO selpercatinib CAPSULE;ORAL 213246 NDA Eli Lilly and Company 0002-2980 0002-2980-60 60 CAPSULE in 1 BOTTLE (0002-2980-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:May 8, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:May 8, 2027
Regulatory Exclusivity Use: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)
Regulatory Exclusivity Expiration:May 8, 2027
Regulatory Exclusivity Use: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
Regulatory Exclusivity Expiration:May 8, 2027
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)

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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.