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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214200


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NDA 214200 describes COSELA, which is a drug marketed by Pharmacosmos and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the COSELA profile page.

The generic ingredient in COSELA is trilaciclib dihydrochloride. One supplier is listed for this compound. Additional details are available on the trilaciclib dihydrochloride profile page.
Summary for 214200
Tradename:COSELA
Applicant:Pharmacosmos
Ingredient:trilaciclib dihydrochloride
Patents:12
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214200
Generic Entry Date for 214200*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS

*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: 214200
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COSELA trilaciclib dihydrochloride POWDER;INTRAVENOUS 214200 NDA G1 Therapeutics, Inc. 73462-101 73462-101-01 1 VIAL, GLASS in 1 CARTON (73462-101-01) / 20 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 300MG BASE/VIAL
Approval Date:Feb 12, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 12, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Mar 14, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD TO DECREASE THE INCIDENCE OF CHEMOTHERAPY-INDUCED MYELOSUPPRESSION IN ADULT PATIENTS WHEN ADMINISTERED PRIOR TO A CARBOPLATIN AND ETOPOSIDE-CONTAINING REGIMEN FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER
Patent:⤷  Sign UpPatent Expiration:Oct 25, 2031Product Flag?Substance Flag?YDelist Request?

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