BREXANOLONE - Generic Drug Details

✉ Email this page to a colleague

What are the generic sources for brexanolone and what is the scope of patent protection?

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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	Y			⤷ Sign Up
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				⤷ 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 BREXANOLONE

Subscribe to access the full database, or Sign Up
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.