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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 3
Stichting ZiektekostenVerzekering Krijgsmacht	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
>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
Australia	2014240102	Pharmaceutical composition of S-ketamine hydrochloride	⤷ Sign Up
Chile	2018000652		⤷ Sign Up
Nicaragua	201500135	COMPOSICIÓN FARMACÉUTICA DE HIDROCLORURO DE S-KETAMINA	⤷ Sign Up
>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.