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ZURZUVAE Drug Patent Profile

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Which patents cover Zurzuvae, and what generic alternatives are available?

Zurzuvae is a drug marketed by Biogen Inc and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in ZURZUVAE is zuranolone. One supplier is listed for this compound. Additional details are available on the zuranolone profile page.

DrugPatentWatch^® Generic Entry Outlook for Zurzuvae

Zurzuvae will be eligible for patent challenges on October 31, 2027. 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 October 31, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZURZUVAE

International Patents:	105
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	53
Drug Prices:	Drug price information for ZURZUVAE
What excipients (inactive ingredients) are in ZURZUVAE?	ZURZUVAE excipients list
DailyMed Link:	ZURZUVAE at DailyMed

Drug patent expirations by year for ZURZUVAE

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

Generic Entry Date for ZURZUVAE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 217369 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.

Pharmacology for ZURZUVAE

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 ZURZUVAE

ZURZUVAE is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZURZUVAE is ⤷ Sign Up.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
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 ZURZUVAE

19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION

Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION

19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting ZURZUVAE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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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	217369-001	Oct 31, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	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 ZURZUVAE

See the table below for patents covering ZURZUVAE around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	7527318		⤷ Sign Up
Australia	2020256400	19-Nor C3,3-Disubstituted C21-N-Pyrazolyl Steroids And Methods Of Use Thereof	⤷ Sign Up
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)	⤷ Sign Up
Singapore	11201508550X	19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration