Details for New Drug Application (NDA): 209445
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NDA 209445 describes FETROJA, which is a drug marketed by Shionogi Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the FETROJA profile page.
The generic ingredient in FETROJA is cefiderocol sulfate tosylate. One supplier is listed for this compound. Additional details are available on the cefiderocol sulfate tosylate profile page.
The generic ingredient in FETROJA is cefiderocol sulfate tosylate. One supplier is listed for this compound. Additional details are available on the cefiderocol sulfate tosylate profile page.
Summary for 209445
| Tradename: | FETROJA |
| Applicant: | Shionogi Inc |
| Ingredient: | cefiderocol sulfate tosylate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209445
Generic Entry Date for 209445*:
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: 209445
Suppliers and Packaging for NDA: 209445
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FETROJA | cefiderocol sulfate tosylate | POWDER;INTRAVENOUS | 209445 | NDA | Shionogi Inc. | 59630-266 | 59630-266-10 | 10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Nov 14, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 14, 2029 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Nov 14, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,004,750 | Patent Expiration: | Sep 3, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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