You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 7, 2024

Zuranolone - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Generic Entry 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

SponsorPhase
Sage TherapeuticsPhase 1

See all zuranolone clinical trials

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 217369-003 Oct 31, 2023 RX Yes Yes ⤷  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 217369-001 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 Y Y ⤷  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 zuranolone

Country Patent Number Title Estimated Expiration
Hungary E055554 ⤷  Sign Up
Serbia 62312 19-NOR C3,3-DISUPSTITUISANI C21-N-PIRAZOLIL STEROIDI I POSTUPCI ZA NJIHOVU UPOTREBU (19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID FOR USE IN THERAPY) ⤷  Sign Up
South Africa 201507740 19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF ⤷  Sign Up
Eurasian Patent Organization 201990565 КРИСТАЛЛИЧЕСКИЙ 19-НОР C3,3-ДИЗАМЕЩЕННЫЙ C21-N-ПИРАЗОЛИЛ СТЕРОИД ⤷  Sign Up
Russian Federation 2015149008 19-НОР C3, 3-ДИЗАМЕЩЕННЫЕ C21-N-ПИРАЗОЛИЛЬНЫЕ СТЕРОИДЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ ⤷  Sign Up
Serbia 58297 19-NOR C3,3-DISUPSTITUISANI C21-N-PIRAZOLIL STEROIDI I POSTUPCI ZA NJIHOVU UPOTREBU (19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF) ⤷  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.