Details for New Drug Application (NDA): 217369
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NDA 217369 describes ZURZUVAE, which is a drug marketed by Biogen and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ZURZUVAE profile page.
The generic ingredient in ZURZUVAE is zuranolone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the zuranolone profile page.
The generic ingredient in ZURZUVAE is zuranolone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the zuranolone profile page.
Summary for 217369
| Tradename: | ZURZUVAE |
| Applicant: | Biogen |
| Ingredient: | zuranolone |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217369
Generic Entry Date for 217369*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 217369
| Mechanism of Action | GABA A Receptor Positive Modulators |
Suppliers and Packaging for NDA: 217369
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZURZUVAE | zuranolone | CAPSULE;ORAL | 217369 | NDA | Biogen MA Inc. | 64406-029 | 64406-029-01 | 1 BOTTLE in 1 CARTON (64406-029-01) / 14 CAPSULE in 1 BOTTLE |
| ZURZUVAE | zuranolone | CAPSULE;ORAL | 217369 | NDA | Biogen MA Inc. | 64406-030 | 64406-030-01 | 1 BOTTLE in 1 CARTON (64406-030-01) / 14 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Oct 31, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 31, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,172,871 | Patent Expiration: | Apr 17, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING POSTPARTUM DEPRESSION | ||||||||
| Patent: | 10,342,810 | Patent Expiration: | Apr 17, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING POSTPARTUM DEPRESSION | ||||||||
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