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 |
Recent Clinical Trials for esketamine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Obstetrics & Gynecology Hospital of Fudan University | Phase 4 |
Beijing Obstetrics and Gynecology Hospital | Phase 4 |
VA Office of Research and Development | Phase 4 |
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 | ||||
>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 |
---|---|---|---|
Mexico | 2017003366 | REGIMENES DE DOSIFICACION Y MÉTODOS ESPECIFICOS PARA EL TRATAMIENTO DE LA DEPRESIÓN CON EL GENOTIPO VAL66MET (SNP RS6265). (VAL66MET (SNP rs6265) GENOTYPE SPECIFIC DOSING REGIMENS AND METHODS FOR THE TREATMENT OF DEPRESSION.) | ⤷ Try a Trial |
European Patent Office | 3636251 | COMPOSITION PHARMACEUTIQUE DE HYDROCHLORURE S-KÉTAMINE (PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE) | ⤷ Try a Trial |
South Korea | 20170054470 | VAL66MET (SNP rs6265) 유전자형 특이적 투여 계획 및 우울증 치료 방법 (VAL66MET SNP rs6265 VAL66MET SNP rs6265 GENOTYPE SPECIFIC DOSING REGIMENS AND METHODS FOR THE TREATMENT OF DEPRESSION) | ⤷ 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 |