Zuranolone - Generic Drug Details

What are the generic sources for zuranolone and what is the scope of freedom to operate?

Zuranolone is the generic ingredient in one branded drug marketed by Biogen Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zuranolone has one hundred and five patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for zuranolone

International Patents:	105
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	1
Patent Applications:	79
What excipients (inactive ingredients) are in zuranolone?	zuranolone excipients list
DailyMed Link:	zuranolone at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for zuranolone

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

CAPSULE;ORAL

^*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 zuranolone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sage Therapeutics	Phase 1

See all zuranolone clinical trials

Pharmacology for zuranolone

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 zuranolone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes				Y

International Patents for zuranolone

Country	Patent Number	Title	Estimated Expiration
Japan	7527318
Australia	2020256400	19-Nor C3,3-Disubstituted C21-N-Pyrazolyl Steroids And Methods Of Use Thereof
Japan	2023154010	１９－ノルＣ３，３－ジ置換Ｃ２１－Ｎ－ピラゾリルステロイドおよびその使用方法 (19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF)
Singapore	11201508550X	19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF
South Korea	20150143690	19-노르 C3,3-이치환된 C21-N-피라졸릴 스테로이드 및 그의 사용 방법 (19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF)
Mexico	2022007432	UN ESTEROIDE 19-NOR-C21-N-PIRAZOLILO C3,3-DISUSTITUIDO CRISTALINO. (A CRYSTALLINE 19-NOR C3, 3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID.)
Jordan	P20190022	ستيرويد 19- نور C3، 3- به استبدال ثنائي لـ C21-N بيرازوليل بلوري (A CRYSTALLINE 19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID)