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Last Updated: April 25, 2024

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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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in twenty-three 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

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for SPRAVATO
International Patents:58
US Patents:7
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 18
Clinical Trials: 3
Patent Applications: 83
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

Recent Clinical Trials for SPRAVATO

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

SponsorPhase
VA Office of Research and DevelopmentPhase 4
Zylorion HealthPhase 2
Janssen Research & Development, LLCPhase 1

See all SPRAVATO clinical trials

Paragraph IV (Patent) Challenges for SPRAVATO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPRAVATO Nasal Spray esketamine hydrochloride 28 mg 211243 3 2023-03-06

US Patents and Regulatory Information for SPRAVATO

SPRAVATO is protected by fifteen US patents and one FDA Regulatory Exclusivity.

Patents protecting SPRAVATO

Methods for the treatment of depression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ANTIDEPRESSANT

Methods for the treatment of depression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DEPRESSION IN ADULTS WITH MOD AND ACUTE SUICIDAL IDEATION OR BEHAVIOR IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE IN A MAINTENANCE PHASE WEEKLY OR LX EVERY 2 WEEKS AFTER INDUCTION PHASE


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

Methods for the treatment of depression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ANTIDEPRESSANT

Methods for the treatment of depression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

Methods for the treatment of depression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DEPRESSIVE SYMPTOMS IN ADULTS WITH MDD WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE AS A PHARMACEUTICAL COMPOSITION TWICE PER WEEK IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE TWICE PER WEEK AS A PHARMACEUTICAL COMPOSITION IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE AS A PHARMACEUTICAL COMPOSITION IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF DEPRESSION IN MDD WITH ACUTE SUICIDAL IDEATION/BEHAVIOR WITH NASALLY ADMINISTERED ESKETAMINE WITH OAD IN A PATIENT WHO HAS MISSED A DOSE IN THE MAINTENANCE PHASE AND HAD WORSENING DEPRESSION SYMPTOMS BY RETURN TO HIGHER DOSING SCHEDULE


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TRD WITH NASALLY ADMINISTERED ESKETAMINE IN CONJUNCTION WITH AN OAD IN A PATIENT WHO HAS MISSED A DOSE DURING THE MAINTENANCE PHASE AND HAD WORSENING OF DEPRESSION SYMPTOM BY RETURNING TO HIGHER DOSING SCHEDULE

Intranasal administration of ketamine to treat depression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TREATMENT-RESISTANT DEPRESSION IN ADULT IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT

Intranasal administration of ketamine to treat depression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPRAVATO esketamine hydrochloride SPRAY;NASAL 211243-001 Mar 5, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
China 111643449 S-盐酸氯胺酮的药物组合物 (Pharmaceutical composition of S-ketamine hydrochloride) ⤷  Try a Trial
Japan 2009530385 ⤷  Try a Trial
Mexico 2015012617 COMPOSICION FARMACEUTICA DE CLORHIDRATO DE S-KETAMINA. (PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE.) ⤷  Try a Trial
Australia 2019200424 Pharmaceutical composition of S-ketamine hydrochloride ⤷  Try a Trial
Dominican Republic S2018000077 ⤷  Try a Trial
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) ⤷  Try a Trial
European Patent Office 3193853 RÉGIMES POSOLOGIQUES SPÉCIFIQUES AU GÉNOTYPE VAL66MET (SNP RS6265) ET MÉTHODES POUR LE TRAITEMENT DE LA DÉPRESSION (VAL66MET (SNP rs6265) GENOTYPE SPECIFIC DOSING REGIMENS AND METHODS FOR THE TREATMENT OF DEPRESSION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.