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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211243


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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 two patents protecting this drug. Additional details are available on the SPRAVATO profile page.

The generic ingredient in SPRAVATO is esketamine hydrochloride. 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:2
Generic Entry Opportunity Date for 211243
Generic Entry Date for 211243*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
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:RXDosage:SPRAY;NASALStrengthEQ 28MG BASE
Approval Date:Mar 5, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 5, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
Patent:  Start TrialPatent Expiration:Jul 9, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULT IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT
Patent:  Start TrialPatent Expiration:Mar 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULT IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT

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