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Last Updated: February 23, 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 patent protection?

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

Esketamine hydrochloride has forty patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for esketamine hydrochloride
International Patents:40
US Patents:6
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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for esketamine hydrochloride
Generic Entry Date for esketamine hydrochloride*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
Dosage:
SPRAY;NASAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ⤷  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 esketamine hydrochloride

Country Patent Number Title Estimated Expiration
Philippines 12015502013 PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE ⤷  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
China 111643449 S-盐酸氯胺酮的药物组合物 (Pharmaceutical composition of S-ketamine hydrochloride) ⤷  Try a Trial
Chile 2015002736 Composición farmacéutica de clorhidrato de s-ketamina. ⤷  Try a Trial
Mexico 2015012617 COMPOSICION FARMACEUTICA DE CLORHIDRATO DE S-KETAMINA. (PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE.) ⤷  Try a Trial
European Patent Office 2968122 COMPOSITION PHARMACEUTIQUE D'HYDROCHLORURE DE S-KÉTAMINE (PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Merck
Dow
Moodys
Express Scripts

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.