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Last Updated: May 24, 2024

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: 120
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

SponsorPhase
Obstetrics & Gynecology Hospital of Fudan UniversityPhase 4
Beijing Obstetrics and Gynecology HospitalPhase 4
VA Office of Research and DevelopmentPhase 4

See all ESKETAMINE HYDROCHLORIDE clinical trials

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

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
>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

Country Patent Number Title Estimated Expiration
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) ⤷  Sign Up
Nicaragua 201800038 ⤷  Sign Up
Australia 2019200424 Pharmaceutical composition of S-ketamine hydrochloride ⤷  Sign Up
Canada 3131929 ESKETAMINE POUR LE TRAITEMENT DE LA DEPRESSION (ESKETAMINE FOR THE TREATMENT OF DEPRESSION) ⤷  Sign Up
China 105073096 Pharmaceutical composition of S-ketamine hydrochloride ⤷  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.