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 fifty-eight patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for ESKETAMINE HYDROCHLORIDE
| International Patents: | 58 |
| 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
| 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 |
|---|---|---|---|
| Morocco | 40620 | RÉGIMES POSOLOGIQUES SPÉCIFIQUES AU GÉNOTYPE VAL66MET (SNP RS6265) ET MÉTHODES POUR LE TRAITEMENT DE LA DÉPRESSION (VAL66MET (SNP rs6265) GENOTYPE SPECIFIC DOSING REGIMENS AND METHODS FOR THE TREATMENT OF DEPRESSION) | ⤷ Try a Trial |
| Canada | 3131929 | ESKETAMINE POUR LE TRAITEMENT DE LA DEPRESSION (ESKETAMINE FOR THE TREATMENT OF DEPRESSION) | ⤷ Try a Trial |
| Japan | 2021054829 | Ｖａｌ６６Ｍｅｔ（ＳＮＰ ｒｓ６２６５）遺伝子型特異的投薬レジメン及びうつ病の治療のための方法 (Val66Met (SNP rs6265) GENOTYPE SPECIFIC DOSING REGIMENS AND METHODS FOR TREATMENT OF DEPRESSION) | ⤷ Try a Trial |
| Canada | 180221 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
