Details for New Drug Application (NDA): 214200
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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: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 300MG BASE/VIAL | ||||
Approval Date: | Feb 12, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Feb 12, 2026 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 14, 2034 | Product 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 Up | Patent Expiration: | Oct 25, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? |
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