Details for New Drug Application (NDA): 218160
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NDA 218160 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 218160
| Tradename: | RETEVMO |
| Applicant: | Loxo Oncol Eli Lilly |
| Ingredient: | selpercatinib |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218160
Generic Entry Date for 218160*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 218160
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RETEVMO | selpercatinib | TABLET;ORAL | 218160 | NDA | Eli Lilly and Company | 0002-5340 | 0002-5340-60 | 60 TABLET, COATED in 1 BOTTLE (0002-5340-60) |
| RETEVMO | selpercatinib | TABLET;ORAL | 218160 | NDA | Eli Lilly and Company | 0002-5562 | 0002-5562-60 | 60 TABLET, COATED in 1 BOTTLE (0002-5562-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 10, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 8, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Oct 10, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Subscribe | Patent Expiration: | Oct 10, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS | ||||||||
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