Details for New Drug Application (NDA): 214096
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NDA 214096 describes TEPMETKO, which is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the TEPMETKO profile page.
The generic ingredient in TEPMETKO is tepotinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tepotinib hydrochloride profile page.
The generic ingredient in TEPMETKO is tepotinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tepotinib hydrochloride profile page.
Summary for 214096
| Tradename: | TEPMETKO |
| Applicant: | Emd Serono Inc |
| Ingredient: | tepotinib hydrochloride |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214096
Generic Entry Date for 214096*:
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.
Pharmacology for NDA: 214096
| Mechanism of Action | Mesenchymal Epithelial Transition Inhibitors P-Glycoprotein Inhibitors |
Suppliers and Packaging for NDA: 214096
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEPMETKO | tepotinib hydrochloride | TABLET;ORAL | 214096 | NDA | EMD Serono, Inc. | 44087-5000 | 44087-5000-3 | 3 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACK |
| TEPMETKO | tepotinib hydrochloride | TABLET;ORAL | 214096 | NDA | EMD Serono, Inc. | 44087-5000 | 44087-5000-6 | 6 BLISTER PACK in 1 CARTON (44087-5000-6) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 225MG BASE | ||||
| Approval Date: | Feb 3, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 3, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 3, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS | ||||||||
| Patent: | 8,329,692 | Patent Expiration: | Oct 30, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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