BREXANOLONE - Generic Drug Details
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What are the generic 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 twenty-one patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for BREXANOLONE
| International Patents: | 121 |
| 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
*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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 BREXANOLONE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20110010742 | SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS | ⤷ Sign Up |
| Russian Federation | 2022102537 | НЕЙРОАКТИВНЫЕ СТЕРОИДЫ, ИХ КОМПОЗИЦИИ И ПРИМЕНЕНИЯ | ⤷ Sign Up |
| China | 114053423 | 磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions) | ⤷ Sign Up |
| Eurasian Patent Organization | 031355 | КОМПОЗИЦИИ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARATION THEREOF) | ⤷ Sign Up |
| Japan | 2010539193 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
