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 |
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.
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
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 |