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Last Updated: November 4, 2024

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. 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
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:RXDosage:TABLET;ORALStrengthEQ 225MG BASE
Approval Date:Feb 3, 2021TE: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 UpPatent Expiration:Oct 30, 2029Product Flag?YSubstance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.