Details for New Drug Application (NDA): 211371
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NDA 211371 describes ZULRESSO, which is a drug marketed by Sage Therap and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ZULRESSO profile page.
The generic ingredient in ZULRESSO is brexanolone. One supplier is listed for this compound. Additional details are available on the brexanolone profile page.
The generic ingredient in ZULRESSO is brexanolone. One supplier is listed for this compound. Additional details are available on the brexanolone profile page.
Summary for 211371
| Tradename: | ZULRESSO |
| Applicant: | Sage Therap |
| Ingredient: | brexanolone |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211371
Generic Entry Date for 211371*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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: 211371
| Mechanism of Action | GABA A Receptor Positive Modulators |
Suppliers and Packaging for NDA: 211371
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371 | NDA | Sage Therapeutics, Inc. | 72152-547 | 72152-547-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72152-547-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/20ML (5MG/ML) | ||||
| Approval Date: | Jun 17, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 17, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 16, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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