ZURANOLONE - Generic Drug Details
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What are the generic drug sources for zuranolone and what is the scope of patent protection?
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 four patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for ZURANOLONE
International Patents: | 104 |
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
Sponsor | Phase |
---|---|
Sage Therapeutics | Phase 1 |
Pharmacology for ZURANOLONE
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 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 | ⤷ 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 | ||
>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 |
---|---|---|---|
Lithuania | 2986623 | ⤷ Sign Up | |
Slovenia | 3498725 | ⤷ Sign Up | |
Singapore | 11201901445T | A CRYSTALLINE 19-NOR C3, 3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID | ⤷ Sign Up |
Hungary | E055554 | ⤷ 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.