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 two suppliers. There are fourteen patents protecting this drug. Additional details are available on the COSELA profile page.
The generic ingredient in COSELA is trilaciclib dihydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the trilaciclib dihydrochloride profile page.
The generic ingredient in COSELA is trilaciclib dihydrochloride. There is one drug master file entry for this compound. Two suppliers are 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: | 14 |
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 |
| COSELA | trilaciclib dihydrochloride | POWDER;INTRAVENOUS | 214200 | NDA | Pharmacosmos Therapeutics Inc. | 73594-0101 | 73594-0101-1 | 1 VIAL, GLASS in 1 CARTON (73594-0101-1) / 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: | ⤷ Start Trial | 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: | ⤷ Start Trial | Patent Expiration: | Oct 25, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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