Details for New Drug Application (NDA): 211371
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The generic ingredient in ZULRESSO is brexanolone. 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.
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/20ML (5MG/ML) | ||||
Approval Date: | Jun 17, 2019 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jun 16, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Patent: | 10,117,951 | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 10,251,894 | Patent Expiration: | Nov 27, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF TREATING POSTPARTUM DEPRESSION |
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