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 three 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
Summary for ZURZUVAE
| International Patents: | 103 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Patent Applications: | 46 |
| 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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION
19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION
Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING POSTPARTUM DEPRESSION
19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting ZURZUVAE
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Inc | ZURZUVAE | zuranolone | CAPSULE;ORAL | 217369-003 | Oct 31, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Inc | ZURZUVAE | zuranolone | CAPSULE;ORAL | 217369-002 | Oct 31, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biogen Inc | ZURZUVAE | zuranolone | CAPSULE;ORAL | 217369-001 | Oct 31, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Biogen Inc | ZURZUVAE | zuranolone | CAPSULE;ORAL | 217369-002 | Oct 31, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| South Korea | 102614507 | ⤷ Try a Trial | |
| Mexico | 2019002193 | UN ESTEROIDE 19-NOR-C21-N-PIRAZOLILO C3,3-DISUSTITUIDO CRISTALINO. (A CRYSTALLINE 19-NOR C3, 3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID.) | ⤷ Try a Trial |
| South Korea | 102239541 | ⤷ Try a Trial | |
| Hong Kong | 1224301 | -去甲 -二取代的 -吡唑基類固醇及其使用方法 (19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF 19- C33- C21-N-) | ⤷ Try a Trial |
| Argentina | 125320 | COMPUESTO CRISTALINO, MÉTODO DE PREPARACIÓN Y COMPOSICIÓN QUE LO COMPRENDE | ⤷ Try a Trial |
| >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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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