ESKETAMINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for esketamine hydrochloride and what is the scope of freedom to operate?

Esketamine hydrochloride is the generic ingredient in one branded drug marketed by Janssen Pharms and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Esketamine hydrochloride has sixty patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for ESKETAMINE HYDROCHLORIDE

International Patents:	60
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	134
Patent Applications:	33
What excipients (inactive ingredients) are in ESKETAMINE HYDROCHLORIDE?	ESKETAMINE HYDROCHLORIDE excipients list
DailyMed Link:	ESKETAMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ESKETAMINE HYDROCHLORIDE

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

Sponsor	Phase
Reinier de Graaf Groep	Phase 3
Stichting ZiektekostenVerzekering Krijgsmacht	Phase 3
Ambulance Amsterdam	Phase 3

See all ESKETAMINE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ESKETAMINE HYDROCHLORIDE

Paragraph IV (Patent) Challenges for ESKETAMINE HYDROCHLORIDE

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 ESKETAMINE HYDROCHLORIDE

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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
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 ESKETAMINE HYDROCHLORIDE

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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
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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