Details for New Drug Application (NDA): 213246

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

The generic ingredient in RETEVMO is selpercatinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the selpercatinib profile page.

Summary for 213246

Tradename:	RETEVMO
Applicant:	Eli Lilly And Co
Ingredient:	selpercatinib
Patents:	6

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213246

Constraining patent/regulatory exclusivity:

10,112,942*PED

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.

Pharmacology for NDA: 213246

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

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:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	May 8, 2020	TE:		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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