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Brexanolone - Generic Drug Details
» See Plans and Pricing
What are the generic sources for brexanolone and what is the scope of freedom to operate?
Brexanolone
is the generic ingredient in one branded drug marketed by Sage Therap and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Brexanolone has sixty-eight patent family members in twenty-five countries.
Summary for brexanolone
| International Patents: | 68 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 44 |
| Clinical Trials: | 2 |
| Patent Applications: | 297 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for brexanolone |
| DailyMed Link: | brexanolone at DailyMed |
Recent Clinical Trials for brexanolone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sage Therapeutics | Phase 4 |
| Sage Therapeutics | Phase 3 |
US Patents and Regulatory Information for brexanolone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 brexanolone
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6039721 | Start Trial |
| Russian Federation | 2681835 | Start Trial |
| Eurasian Patent Organization | 201000828 | Start Trial |
| South Africa | 201405401 | Start Trial |
| Hong Kong | 1219883 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
