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 twenty-three patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for brexanolone

International Patents:	123
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

Generic Entry Date for brexanolone^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 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

See all brexanolone clinical trials

Pharmacology for brexanolone

Drug Class	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of Action	GABA A Receptor Positive Modulators

Anatomical Therapeutic Chemical (ATC) Classes for brexanolone

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for brexanolone

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Glossary

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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	Y			⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	031355		⤷ Sign Up
Israel	300422	סטירואידים פעילים עצבית, תכשירים ושימושים בהם (Neuroactive steroids, compositions, and uses thereof)	⤷ 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
Israel	286348	תכשירים פרמצבטיים הכוללים אלופרגננולון (Pharmaceutical compositions comprising allopregnanolone)	⤷ Sign Up
Canada	2862076	FORMULATION DE STEROIDE NEUROACTIF ET PROCEDES DE TRAITEMENT DES TROUBLES DE SNC (NEUROACTIVE STEROID FORMULATIONS AND METHODS OF TREATING CNS DISORDERS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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.