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Details for New Drug Application (NDA): 205435
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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 205435
Tradename: | SIVEXTRO |
Applicant: | Cubist Pharms Llc |
Ingredient: | tedizolid phosphate |
Patents: | 7 |
Generic Entry Opportunity Date for 205435
Generic Entry Date for 205435*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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: 205435
Mechanism of Action | Breast Cancer Resistance Protein Inhibitors |
Suppliers and Packaging for NDA: 205435
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIVEXTRO | tedizolid phosphate | TABLET;ORAL | 205435 | NDA | Merck Sharp & Dohme Corp. | 67919-041 | 67919-041-01 | 30 TABLET, FILM COATED in 1 BOTTLE (67919-041-01) |
SIVEXTRO | tedizolid phosphate | TABLET;ORAL | 205435 | NDA | Merck Sharp & Dohme Corp. | 67919-041 | 67919-041-02 | 1 BLISTER PACK in 1 CARTON (67919-041-02) > 6 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jun 20, 2014 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jun 19, 2023 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Jun 20, 2019 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Jun 20, 2024 | ||||||||
Regulatory Exclusivity Use: |
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