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Last Updated: January 18, 2020

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SPRAVATO Drug Profile

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Which patents cover Spravato, and what generic alternatives are available?

Spravato is a drug marketed by Janssen Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has seven patent family members in seven countries.

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.

US ANDA Litigation and Generic Entry Outlook for Spravato

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Spravato was eligible for patent challenges on December 31st, 1968.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 5th, 2024. This may change due to patent challenges or generic licensing.

Summary for SPRAVATO
Drug patent expirations by year for SPRAVATO
Drug Prices for SPRAVATO

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Generic Entry Opportunity Date for SPRAVATO
Generic Entry Date for SPRAVATO*:
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).
NDA:
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.

Synonyms for SPRAVATO
(-)-Ketamine
(2S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexan-1-one
(2S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone
(2S)-2-(2-chlorophenyl)-2-methylaminocyclohexan-1-one
(S)-(-)-Ketamine
(S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone
(S)-Ketamine
33643-46-8
50LFG02TXD
AC1L4AD8
AKOS027321219
CAS-33643-46-8
CHEBI:60799
CHEMBL395091
cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (2S)-
Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (2S)- (9CI)
Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (S)-
Cyclohexanone, 2-(o-chlorophenyl)-2-(methylamino)-, (-)- (8CI)
CYCLOHEXANONE,2-(2-CHLOROPHENYL)-2-(METHYLAMINO)-, (2S)-
D07283
DB11823
DSSTox_CID_27787
DSSTox_GSID_47810
DSSTox_RID_82562
DTXSID6047810
Esketamine
Esketamine (USAN/INN)
Esketamine [USAN:INN:BAN]
GTPL9152
l-Ketamine
NCGC00185910-01
S-(-)-Ketamine
S-Ketamin
S-Ketamine
SCHEMBL5512024
Tox21_113206
UNII-50LFG02TXD
UNII-690G0D6V8H component YQEZLKZALYSWHR-ZDUSSCGKSA-N
YQEZLKZALYSWHR-ZDUSSCGKSA-N
ZINC35999642

US Patents and Regulatory Information for SPRAVATO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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