Brexanolone - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for brexanolone and what is the scope of patent protection?
Brexanolone
is the generic ingredient in one branded drug marketed by Sage Therap and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Brexanolone has one hundred and nineteen patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for brexanolone
| International Patents: | 119 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Clinical Trials: | 11 |
| Patent Applications: | 1,004 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for brexanolone |
| What excipients (inactive ingredients) are in brexanolone? | brexanolone excipients list |
| DailyMed Link: | brexanolone at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for brexanolone
Generic Entry Date for brexanolone*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*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 brexanolone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brii Biosciences Limited | Phase 1 |
| Sage Therapeutics | Phase 2 |
| Brigham and Women's Hospital | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for brexanolone
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 brexanolone
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 114053423 | 磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions) | ⤷ Try a Trial |
| South Korea | 102408399 | ⤷ Try a Trial | |
| Mexico | 2022003896 | ESTEROIDES NEUROACTIVOS, COMPOSICIONES Y USOS DE LOS MISMOS. (NEUROACTIVE STEROIDS, COMPOSITIONS, AND USES THEREOF.) | ⤷ Try a Trial |
| Singapore | 11201503882S | NEUROACTIVE STEROID FORMULATIONS AND METHODS OF TREATING CNS DISORDERS | ⤷ Try a Trial |
| Argentina | 107833 | ESTEROIDES NEUROACTIVOS, COMPOSICIONES Y USOS DE LOS MISMOS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
