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 two NDAs. 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.
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
*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: | 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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