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Details for New Drug Application (NDA): 205436
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NDA 205436 describes SIVEXTRO, which is a drug marketed by Cubist Pharms Llc and is included in two NDAs. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the SIVEXTRO profile page.
The generic ingredient in SIVEXTRO is tedizolid phosphate. One supplier is listed for this compound. Additional details are available on the tedizolid phosphate profile page.
The generic ingredient in SIVEXTRO is tedizolid phosphate. One supplier is listed for this compound. Additional details are available on the tedizolid phosphate profile page.
Summary for 205436
| Tradename: | SIVEXTRO |
| Applicant: | Cubist Pharms Llc |
| Ingredient: | tedizolid phosphate |
| Patents: | 7 |
Generic Entry Opportunity Date for 205436
Generic Entry Date for 205436*:
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: 205436
| Mechanism of Action | Breast Cancer Resistance Protein Inhibitors |
Suppliers and Packaging for NDA: 205436
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SIVEXTRO | tedizolid phosphate | POWDER;INTRAVENOUS | 205436 | NDA | Merck Sharp & Dohme Corp. | 67919-040 | 67919-040-01 | 10 VIAL, GLASS in 1 CARTON (67919-040-01) > 4 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 200MG/VIAL | ||||
| Approval Date: | Jun 20, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 20, 2024 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Jun 20, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 19, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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