Generic Zurzuvae Availability
Last updated on Mar 13, 2025.
Zurzuvae is a brand name of zuranolone, approved by the FDA in the following formulation(s):
ZURZUVAE (zuranolone - capsule;oral)
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Manufacturer: BIOGEN INC
Approval date: October 31, 2023
Strength(s): 20MG [RLD], 25MG [RLD], 30MG [RLD]
Has a generic version of Zurzuvae been approved?
No. There is currently no therapeutically equivalent version of Zurzuvae available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zurzuvae. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Patent 10,172,871
Issued: January 8, 2019
Inventor(s): Martinez Botella Gabriel & Harrison Boyd L. & Robichaud Albert Jean & Salituro Francesco G. & Beresis Richard Thomas
Assignee(s): Sage Therapeutics, Inc.Provided herein are 19-nor C3,3-disubstituted C21-pyrazolyl steroids of Formula (I):
Patent expiration dates:
- April 17, 2034✓
- April 17, 2034
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19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Patent 10,342,810
Issued: July 9, 2019
Inventor(s): Martinez Botella Gabriel & Harrison Boyd L. & Robichaud Albert Jean & Salituro Francesco G. & Beresis Richard Thomas
Assignee(s): Sage Therapeutics, Inc.Provided herein are 19-nor C3,3-disubstituted C21-pyrazolyl steroids of Formula (I):
Patent expiration dates:
- April 17, 2034✓
- April 17, 2034
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Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid
Patent 11,236,121
Issued: February 1, 2022
Inventor(s): Watson Paul Steven & Berner Bret & Reid John Gregory & Wang Jian & Doherty James J. & Kanes Stephen Jay
Assignee(s): Sage Therapeutics, Inc.This invention relates to a 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and crystalline solid forms and compositions thereof. Also disclosed herein are methods of making crystalline solid forms of the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and methods of using the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) or crystalline solid forms, pharmaceutically acceptable salts, and pharmaceutically acceptable compositions thereof.
Patent expiration dates:
- August 23, 2037✓
- August 23, 2037
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Patent 11,884,696
Patent expiration dates:
- August 23, 2037✓
- August 23, 2037
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19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof
Patent 9,512,165
Issued: December 6, 2016
Inventor(s): Martinez Botella Gabriel & Harrison Boyd L. & Robichaud Albert Jean & Salituro Francesco G. & Beresis Richard Thomas
Assignee(s): SAGE THERAPEUTICS, INC.Provided herein are 19-nor C3,3-disubstituted C21-pyrazolyl steroids of Formula (I), and pharmaceutically acceptable salts thereof; wherein, R, R, R, R, R, R, R, R, and Rare as defined herein. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, treatment of sleep disorders, mood disorders, schizophrenia spectrum disorders, convulsive disorders, disorders of memory and/or cognition, movement disorders, personality disorders, autism spectrum disorders, pain, traumatic brain injury, vascular diseases, substance abuse disorders and/or withdrawal syndromes, and tinnitus.
Patent expiration dates:
- April 17, 2034✓✓
- April 17, 2034
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- October 31, 2028 - NEW CHEMICAL ENTITY
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
