Zuranolone - Generic Drug Details

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

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

Generic Entry Date for zuranolone^: ⤷ Subscribe* 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

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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
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	10,342,810	⤷ Subscribe				⤷ Subscribe
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	10,172,871	⤷ Subscribe				⤷ Subscribe
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	11,884,696	⤷ Subscribe				⤷ Subscribe
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	9,512,165	⤷ Subscribe	Y	Y		⤷ Subscribe
>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 zuranolone

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Country	Patent Number	Title	Estimated Expiration
Japan	2023002846	結晶性１９－ノルＣ３，３－二置換Ｃ２１－Ｎ－ピラゾリルステロイド	⤷ Subscribe
Australia	2022205157	19-nor C3,3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof	⤷ Subscribe
Brazil	112015026380	esteróides 19-nor-c3,3-c21-n-pirazolil dissubstituídos e métodos de utilização dos mesmos	⤷ Subscribe
South Korea	102396328		⤷ Subscribe
Australia	2020256400	19-Nor C3,3-Disubstituted C21-N-Pyrazolyl Steroids And Methods Of Use Thereof	⤷ Subscribe
>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.

Summary for zuranolone

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

Recent Clinical Trials for zuranolone

Pharmacology for zuranolone

Make Better Decisions: Try a trial or see plans & pricing

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