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Last Updated: December 13, 2024

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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
Drug Prices for ZURZUVAE

See drug prices for ZURZUVAE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZURZUVAE
Generic Entry Date for ZURZUVAE*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
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.

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

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

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
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 217369-002 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 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.

Country Patent Number Title Estimated Expiration
Japan 2019524853 結晶性19−ノルC3,3−二置換C21−N−ピラゾリルステロイド ⤷  Sign Up
China 105339381 19-nor C3,3-disubstituted C21-n-pyrazolyl steroids and methods of use thereof ⤷  Sign Up
Argentina 125321 COMPUESTO CRISTALINO, MÉTODO DE PREPARACIÓN Y COMPOSICIÓN QUE LO COMPRENDE ⤷  Sign Up
Taiwan 202342059 A crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid ⤷  Sign Up
Poland 2986623 ⤷  Sign Up
China 110088091 19-去甲C3,3-二取代的C21-N-吡唑基类固醇的晶体 (A CRYSTALLINE 19-NOR C3, 3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID) ⤷  Sign Up
Brazil 112019003637 um esteróide 19-nor c3,3-dissubstituído c21-n-pirazolil cristalino ⤷  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.