Details for New Drug Application (NDA): 210661
NDA 210661 describes AXTLE, which is a drug marketed by Avyxa Holdings and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the AXTLE profile page.
The generic ingredient in AXTLE is pemetrexed dipotassium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed dipotassium profile page.
The generic ingredient in AXTLE is pemetrexed dipotassium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed dipotassium profile page.
Summary for 210661
| Tradename: | AXTLE |
| Applicant: | Avyxa Holdings |
| Ingredient: | pemetrexed dipotassium |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210661
Generic Entry Date for 210661*:
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.
Pharmacology for NDA: 210661
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 210661
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AXTLE | pemetrexed dipotassium | POWDER;INTRAVENOUS | 210661 | NDA | Avyxa Pharma, LLC | 83831-111 | 83831-111-01 | 1 VIAL in 1 CARTON (83831-111-01) / 4 mL in 1 VIAL |
| AXTLE | pemetrexed dipotassium | POWDER;INTRAVENOUS | 210661 | NDA | Avyxa Pharma, LLC | 83831-112 | 83831-112-01 | 1 VIAL in 1 CARTON (83831-112-01) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 25, 2045 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 25, 2045 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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