ZULRESSO Drug Patent Profile
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When do Zulresso patents expire, and when can generic versions of Zulresso launch?
Zulresso is a drug marketed by Sage Therap and is included in one NDA. There are eight patents protecting this drug.
This drug has one hundred and twenty-six patent family members in thirty-two countries.
The generic ingredient in ZULRESSO is brexanolone. Additional details are available on the brexanolone profile page.
DrugPatentWatch® Generic Entry Outlook for Zulresso
Zulresso was eligible for patent challenges on June 17, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 13, 2029. This may change due to patent challenges or generic licensing.
There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for ZULRESSO?
- What are the global sales for ZULRESSO?
- What is Average Wholesale Price for ZULRESSO?
Summary for ZULRESSO
International Patents: | 126 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 7 |
Patent Applications: | 526 |
Drug Prices: | Drug price information for ZULRESSO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZULRESSO |
What excipients (inactive ingredients) are in ZULRESSO? | ZULRESSO excipients list |
DailyMed Link: | ZULRESSO at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZULRESSO
Generic Entry Date for ZULRESSO*:
Constraining patent/regulatory exclusivity:
NDA:
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 ZULRESSO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Brigham and Women's Hospital | Phase 4 |
Yale University | Phase 1 |
Sage Therapeutics | Phase 1 |
US Patents and Regulatory Information for ZULRESSO
ZULRESSO is protected by eight US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZULRESSO is ⤷ Try for Free.
This potential generic entry date is based on patent 7,635,773.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | DISCN | Yes | No | 10,940,156 | ⤷ Try for Free | ⤷ Try for Free | ||||
Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | DISCN | Yes | No | 10,322,139 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | DISCN | Yes | No | 9,200,088 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 ZULRESSO
When does loss-of-exclusivity occur for ZULRESSO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09241858
Patent: Sulfoalkyl ether cyclodextrin compositions
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0905080
Patent: Composições, processo para reparar uma composição e produto
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 02603
Patent: COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Patent: 71879
Patent: COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
China
Patent: 1959508
Patent: Sulfoalkyl ether cyclodextrin compositions
Estimated Expiration: ⤷ Try for Free
Patent: 5288650
Patent: Sulfoalkyl ether cyclodextrin compositions
Estimated Expiration: ⤷ Try for Free
Patent: 4053423
Patent: 磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions)
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 1355
Patent: КОМПОЗИЦИИ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARATION THEREOF)
Estimated Expiration: ⤷ Try for Free
Patent: 1000828
Patent: СОСТАВЫ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 68269
Patent: COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Patent: 63430
Patent: COMPOSITIONS D'ÉTHER SULFOALKYLE DE CYCLODEXTRINE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 19883
Patent: 磺烷基醚環糊精組合物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 8956
Patent: תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)
Estimated Expiration: ⤷ Try for Free
Patent: 3654
Patent: תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 23144
Estimated Expiration: ⤷ Try for Free
Patent: 39721
Estimated Expiration: ⤷ Try for Free
Patent: 76828
Estimated Expiration: ⤷ Try for Free
Patent: 44548
Estimated Expiration: ⤷ Try for Free
Patent: 10539193
Estimated Expiration: ⤷ Try for Free
Patent: 12072160
Patent: SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION
Estimated Expiration: ⤷ Try for Free
Patent: 15110671
Patent: スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Patent: 17019879
Patent: スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Patent: 18052991
Patent: スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 2459
Patent: COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Estimated Expiration: ⤷ Try for Free
Patent: 10004900
Patent: COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 9290
Patent: SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1314803
Estimated Expiration: ⤷ Try for Free
Patent: 110010742
Patent: SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ZULRESSO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4923144 | ⤷ Try for Free | |
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 for Free |
Denmark | 2806877 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZULRESSO
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