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Last Updated: June 27, 2022

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 patent family members in twenty-nine countries.

The generic ingredient in ZULRESSO is brexanolone. Additional details are available on the brexanolone profile page.

DrugPatentWatch® Generic Entry Outlook for Zulresso

Zulresso will be eligible for patent challenges on June 17, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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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Summary for ZULRESSO
Drug patent expirations by year for ZULRESSO
Drug Prices for ZULRESSO

See drug prices for ZULRESSO

DrugPatentWatch® Estimated Generic Entry Opportunity 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

SponsorPhase
Brigham and Women's HospitalPhase 4
Sage TherapeuticsPhase 1
Donald Jeffrey NewportPhase 4

See all ZULRESSO clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Anticonvulsant activity of steroids
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION

Neuroactive steroid formulations and methods of treating CNS disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Neuroactive steroids, compositions, and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ZULRESSO

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
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 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 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 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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0905080
Estimated Expiration: See Plans and Pricing

Canada

Patent: 02603
Estimated Expiration: See Plans and Pricing

Patent: 71879
Estimated Expiration: See Plans and Pricing

China

Patent: 1959508
Estimated Expiration: See Plans and Pricing

Patent: 5288650
Estimated Expiration: See Plans and Pricing

Patent: 4053423
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1355
Estimated Expiration: See Plans and Pricing

Patent: 1000828
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 68269
Estimated Expiration: See Plans and Pricing

Patent: 63430
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 19883
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8956
Estimated Expiration: See Plans and Pricing

Patent: 3654
Estimated Expiration: See Plans and Pricing

Japan

Patent: 23144
Estimated Expiration: See Plans and Pricing

Patent: 39721
Estimated Expiration: See Plans and Pricing

Patent: 76828
Estimated Expiration: See Plans and Pricing

Patent: 44548
Estimated Expiration: See Plans and Pricing

Patent: 10539193
Estimated Expiration: See Plans and Pricing

Patent: 12072160
Estimated Expiration: See Plans and Pricing

Patent: 15110671
Estimated Expiration: See Plans and Pricing

Patent: 17019879
Estimated Expiration: See Plans and Pricing

Patent: 18052991
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2459
Estimated Expiration: See Plans and Pricing

Patent: 10004900
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9290
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1314803
Estimated Expiration: See Plans and Pricing

Patent: 110010742
Estimated Expiration: See Plans and Pricing

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
Canada 3017172 STEROIDES NEUROACTIFS, COMPOSITIONS, ET LEURS UTILISATIONS (NEUROACTIVE STEROIDS, COMPOSITIONS, AND USES THEREOF) See Plans and Pricing
New Zealand 755699 Neuroactive steroid formulations and methods of treating cns disorders See Plans and Pricing
Serbia 59734 FORMULACIJE NEUROAKTIVNOG STEROIDA KOJE UKLJUČUJU KOMPLEKS ALOPREGNANOLONA I SULFOBUTIL ETAR BETA-CIKLODEKSTRINA (NEUROACTIVE STEROID FORMULATIONS COMPRISING A COMPLEX OF ALLOPREGNANOLONE AND SULFOBUTYL ETHER BETA-CYCLODEXTRIN) See Plans and Pricing
Mexico 352459 COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.) See Plans and Pricing
Japan 2018076341 向神経活性ステロイド製剤およびCNS障害の処置方法 (NEUROACTIVE STEROID FORMULATION AND METHODS FOR TREATING CNS DISORDERS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Medtronic
McKinsey
Baxter
Moodys

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.