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SPRAVATO Drug Patent Profile

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When do Spravato patents expire, and what generic alternatives are available?

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 sixty patent family members in twenty-four 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:	60
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	4
Patent Applications:	265
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

Recent Clinical Trials for SPRAVATO

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

Sponsor	Phase
Royal North Shore Hospital	Phase 4
Janssen-Cilag Pty Ltd	Phase 4
VA Office of Research and Development	Phase 4

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

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Patent Expiration: ⤷ Sign Up
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

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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

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Patent Expiration: ⤷ Sign Up
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

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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

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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

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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
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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: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	SPRAVATO	esketamine hydrochloride	SPRAY;NASAL	211243-001	Mar 5, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Mexico	2015012617	COMPOSICION FARMACEUTICA DE CLORHIDRATO DE S-KETAMINA. (PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE.)	⤷ Sign Up
Taiwan	D198501		⤷ Sign Up
Mexico	371392	COMPOSICION FARMACEUTICA DE CLORHIDRATO DE S-KETAMINA. (PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE.)	⤷ Sign Up
Peru	20200404	COMPOSICION FARMACEUTICA DE CLORHIDRATO DE S-KETAMINA	⤷ Sign Up
Israel	279119	משטרי מינון ספציפים לגנוטייפ val66met (snp rs6265) ושיטות לטיפול בדיכאון (Val66met (snp rs6265) genotype specific dosing regimens and methods for the treatment of depression)	⤷ Sign Up
South Korea	20090029690	INTRANASAL ADMINISTRATION OF KETAMINE TO TREAT DEPRESSION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration