Details for New Drug Application (NDA): 214096
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The generic ingredient in TEPMETKO is tepotinib hydrochloride. 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: | ⤷ Sign Up | Patent Expiration: | Oct 30, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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