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Last Updated: May 19, 2022

SPRAVATO Drug Patent Profile


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Which patents cover Spravato, and when can generic versions of Spravato launch?

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

This drug has twenty patent family members in ten 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.

DrugPatentWatch® Generic Entry Outlook for Spravato

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

Indicators of Generic Entry

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Summary for SPRAVATO
International Patents:20
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 14
Clinical Trials: 2
Patent Applications: 357
Drug Prices: Drug price information for SPRAVATO
What excipients (inactive ingredients) are in SPRAVATO?SPRAVATO excipients list
DailyMed Link:SPRAVATO at DailyMed
Drug patent expirations by year for SPRAVATO
Drug Prices for SPRAVATO

See drug prices for SPRAVATO

DrugPatentWatch® Estimated 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.

Recent Clinical Trials for SPRAVATO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Zylorion HealthPhase 2
Janssen Research & Development, LLCPhase 1

See all SPRAVATO clinical trials

US Patents and Regulatory Information for SPRAVATO

SPRAVATO is protected by six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SPRAVATO is See Plans and Pricing.

This potential generic entry date is based on NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT)..

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SPRAVATO

Methods for the treatment of depression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Methods for the treatment of depression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE IN CONJUNCTION WITH AN ORAL ANTIDEPRESSENT

Methods for the treatment of depression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRD IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE IN A MAINTENANCE PHASE WEEKLY OR 1X EVERY TWO WEEKS TO ADULTS WHO HAVE BEEN ADMINISTERED ESKETAMINE IN A INDUCTION PHASE FOR ABOUT 4 WEEKS

Intranasal administration of ketamine to treat depression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULT IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT

Intranasal administration of ketamine to treat depression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULT IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT

FDA Regulatory Exclusivity protecting SPRAVATO

NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF SYMPTOMS IN ADULTS WITH MAJOR DEPRESSIVE DISORDER (MDD) WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR.
Exclusivity Expiration: See Plans and Pricing

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

International Patents for SPRAVATO

See the table below for patents covering SPRAVATO around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2012762 ADMINISTRATION INTRA-NASALE DE KETAMINE POUR TRAITER LA DEPRESSION (INTRANASAL ADMINISTRATION OF KETAMINE TO TREAT DEPRESSION) See Plans and Pricing
China 107208133 用于治疗抑郁症的Val66Met (SNPrs6265)基因型特异性给药方案和方法 (Val66met (snp rs6265) genotype specific dosing regimens and methods for the treatment of depression) See Plans and Pricing
European Patent Office 3725307 RÉGIMES POSOLOGIQUES SPÉCIFIQUES AU GÉNOTYPE VAL66MET (SNP RS6265) ET PROCÉDÉS POUR LE TRAITEMENT DE LA DÉPRESSION (VAL66MET (SNP RS6265) GENOTYPE SPECIFIC DOSING REGIMENS AND METHODS FOR THE TREATMENT OF DEPRESSION) See Plans and Pricing
Canada 2961208 REGIMES POSOLOGIQUES SPECIFIQUES AU GENOTYPE VAL66MET (SNP RS6265) ET METHODES POUR LE TRAITEMENT DE LA DEPRESSION (VAL66MET (SNP RS6265) GENOTYPE SPECIFIC DOSING REGIMENS AND METHODS FOR THE TREATMENT OF DEPRESSION) See Plans and Pricing
South Korea 20090029690 INTRANASAL ADMINISTRATION OF KETAMINE TO TREAT DEPRESSION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.