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 six patent family members in thirty countries.
One supplier is listed for this compound.
Summary for brexanolone
| International Patents: | 106 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 10 |
| Patent Applications: | 1,261 |
| 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 |
Recent Clinical Trials for brexanolone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sage Therapeutics | Phase 2 |
| Brigham and Women's Hospital | Phase 4 |
| Sage Therapeutics | Phase 1 |
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 | 4923144 | See Plans and Pricing | |
| Brazil | 112014018110 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 2013112605 | See Plans and Pricing | |
| Japan | 6838074 | See Plans and Pricing | |
| Canada | 3017172 | STEROIDES NEUROACTIFS, COMPOSITIONS, ET LEURS UTILISATIONS (NEUROACTIVE STEROIDS, COMPOSITIONS, AND USES THEREOF) | See Plans and Pricing |
| Japan | 2018193377 | ステロイドの抗痙攣活性 (ANTICONVULSANT ACTIVITY OF STEROIDS) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
