Esketamine hydrochloride - Generic Drug Details
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What are the generic 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 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 |
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
| 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 |
|---|---|---|---|
| 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 |
| Nicaragua | 201800038 | ⤷ Sign Up | |
| Singapore | 11201507347Q | PHARMACEUTICAL COMPOSITION OF S-KETAMINE HYDROCHLORIDE | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
