BREXANOLONE - Generic Drug Details
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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 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 |
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 | ||||
| >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 |
|---|---|---|---|
| Japan | 6966981 | ⤷ Try a Trial | |
| Japan | 6838074 | ⤷ Try a Trial | |
| Slovenia | 2806877 | ⤷ Try a Trial | |
| Japan | 2015513316 | 向神経活性ステロイド製剤およびＣＮＳ障害の処置方法 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
