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-three patent family members in thirty-one countries.
The generic ingredient in ZULRESSO is brexanolone. One supplier is listed for this compound. 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
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Questions you can ask:
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Summary for ZULRESSO
| International Patents: | 123 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Clinical Trials: | 7 |
| Patent Applications: | 513 |
| 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
*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 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 1 |
| Yale University | Phase 1 |
Pharmacology for ZULRESSO
| Drug Class | Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator |
| Mechanism of Action | GABA A Receptor Positive Modulators |
US Patents and Regulatory Information for ZULRESSO
ZULRESSO is protected by eight US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZULRESSO is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ZULRESSO
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Anticonvulsant activity of steroids
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION
Neuroactive steroid formulations and methods of treating CNS disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Neuroactive steroids, compositions, and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting ZULRESSO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ 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 | Y | ⤷ Sign Up | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 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: ⤷ Sign Up
Brazil
Patent: 0905080
Patent: Composições, processo para reparar uma composição e produto
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 02603
Patent: COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 71879
Patent: COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1959508
Patent: Sulfoalkyl ether cyclodextrin compositions
Estimated Expiration: ⤷ Sign Up
Patent: 5288650
Patent: Sulfoalkyl ether cyclodextrin compositions
Estimated Expiration: ⤷ Sign Up
Patent: 4053423
Patent: 磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 1000828
Patent: СОСТАВЫ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 68269
Patent: COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 63430
Patent: COMPOSITIONS D'ÉTHER SULFOALKYLE DE CYCLODEXTRINE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 19883
Patent: 磺烷基醚環糊精組合物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8956
Patent: תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)
Estimated Expiration: ⤷ Sign Up
Patent: 3654
Patent: תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 23144
Estimated Expiration: ⤷ Sign Up
Patent: 39721
Estimated Expiration: ⤷ Sign Up
Patent: 76828
Estimated Expiration: ⤷ Sign Up
Patent: 44548
Estimated Expiration: ⤷ Sign Up
Patent: 10539193
Estimated Expiration: ⤷ Sign Up
Patent: 12072160
Patent: SULFOALKYL ETHER CYCLODEXTRIN COMPOSITION
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Mexico
Patent: 2459
Patent: COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
Patent: 10004900
Patent: COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9290
Patent: SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1314803
Estimated Expiration: ⤷ Sign Up
Patent: 110010742
Patent: SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Israel | 276403 | תכשירים פרמצבטיים הכוללים אלופרגננולון (Pharmaceutical compositions comprising allopregnanolone) | ⤷ Sign Up |
| European Patent Office | 4295908 | FORMULATIONS STÉROÏDIENNES NEUROACTIVES COMPRENANT UN COMPLEXE D'ALLOPRÉGNANOLONE ET D'ÉTHER SULFOBUTYLIQUE BÊTA-CYCLODEXTRINE (NEUROACTIVE STEROID FORMULATIONS COMPRISING A COMPLEX OF ALLOPREGNANOLONE AND SULFOBUTYL ETHER BETA-CYCLODEXTRIN) | ⤷ Sign Up |
| New Zealand | 773177 | Neuroactive steroid formulations and methods of treating cns disorders | ⤷ Sign Up |
| Taiwan | I798173 | ⤷ Sign Up | |
| China | 114053423 | 磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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