Details for New Drug Application (NDA): 211243
NDA 211243 describes SPRAVATO, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the SPRAVATO profile page.
The generic ingredient in SPRAVATO is esketamine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the esketamine hydrochloride profile page.
The generic ingredient in SPRAVATO is esketamine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the esketamine hydrochloride profile page.
Summary for 211243
| Tradename: | SPRAVATO |
| Applicant: | Janssen Pharms |
| Ingredient: | esketamine hydrochloride |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211243
Generic Entry Date for 211243*:
Constraining patent/regulatory exclusivity:
EXPANSION OF THE INDICATION TO INCLUDE MONOTHERAPY OF ESKETAMINE FOR TREATMENT-RESISTANT DEPRESSION (TRD) Dosage:
SPRAY;NASAL |
*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.
Suppliers and Packaging for NDA: 211243
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SPRAVATO | esketamine hydrochloride | SPRAY;NASAL | 211243 | NDA | Janssen Pharmaceuticals, Inc. | 50458-028 | 50458-028-02 | 2 BLISTER PACK in 1 KIT (50458-028-02) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00) |
| SPRAVATO | esketamine hydrochloride | SPRAY;NASAL | 211243 | NDA | Janssen Pharmaceuticals, Inc. | 50458-028 | 50458-028-03 | 3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | EQ 28MG BASE | ||||
| Approval Date: | Mar 5, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 17, 2028 | ||||||||
| Regulatory Exclusivity Use: | EXPANSION OF THE INDICATION TO INCLUDE MONOTHERAPY OF ESKETAMINE FOR TREATMENT-RESISTANT DEPRESSION (TRD) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 10, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DEPRESSIVE SYMPTOMS IN ADULTS WITH MDD WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR BY NASALLY ADMINISTERING 56MG OR 84 MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 10, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE FOLLOWED BY A MAINTENANCE PHASE OF 56MG OR 84 MG WEEKLY OR 1X EVERY TWO WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT | ||||||||
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