Generic Zulresso Availability
Last updated on Apr 10, 2025.
Zulresso is a brand name of brexanolone, approved by the FDA in the following formulation(s):
ZULRESSO (brexanolone - solution;intravenous)
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Manufacturer: SAGE THERAP
Approval date: June 17, 2019
Strength(s): 100MG/20ML (5MG/ML) (discontinued) [RLD]
All of the above formulations have been discontinued.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zulresso. 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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Sulfoalkyl ether cyclodextrin compositions
Patent 10,117,951
Issued: November 6, 2018
Inventor(s): Antle Vincent D.
Assignee(s): CyDex Pharmaceuticals, Inc.SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
Patent expiration dates:
- March 13, 2029✓
- March 13, 2029
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Anticonvulsant activity of steroids
Patent 10,251,894
Issued: April 9, 2019
Inventor(s): Rogawski Michael A. & Zolkowska Dorota
Assignee(s): THE REGENTS OF THE UNIVERSITY OF CALIFORNIAThe present invention relates to methods of preventing, inhibiting, delaying, and/or mitigating seizures by administration of a steroid, e.g., a neurosteroid, e.g., allopregnanolone.
Patent expiration dates:
- November 27, 2033✓
- November 27, 2033
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Neuroactive steroid formulations and methods of treating CNS disorders
Patent 10,322,139
Issued: June 18, 2019
Inventor(s): Reddy Kiran
Assignee(s): Sage Therapeutics, Inc.Formulations of comprising a neuroactive steroid, e.g., allopregnanolone; and optionally a cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., a β-cyclodextrin, e.g., a sulfo butyl ether β-cyclodextrin, e.g., CAPTISOL®; and methods of use in treating CNS disorders.
Patent expiration dates:
- January 23, 2033✓
- January 23, 2033
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Neuroactive steroids, compositions, and uses thereof
Patent 10,940,156
Issued: March 9, 2021
Inventor(s): Kanes; Stephen Jay et al.
Assignee(s): Sage Therapeutics, Inc. (Cambridge, MA)Described herein are methods of treating a disorder, e.g., tremor, e.g., essential tremor; depression, e.g., postpostum depression; and anxiety disorder, the method comprising administering to a human subject suffering from a disorder, e.g., tremor, e.g., essential tremor; depression, e.g., postpostum depression, an anxiety disorder with a neuroactive steroid or a composition comprising a neuroactive steroid (e.g., pregnanolone, allopregnanolone, alphadalone, ganaxolone, or alphaxolone).
Patent expiration dates:
- March 8, 2037✓
- March 8, 2037
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Sulfoalkyl ether cyclodextrin compositions
Patent 7,635,773
Issued: December 22, 2009
Inventor(s): Antle; Vincent
Assignee(s): CyDex Pharmaceuticals, Inc. (Lenexa, KS)SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD composition comprises a sulfoalkyl ether cyclodextrin and less than 100 ppm of a phosphate, wherein the SAE-CD composition has an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
Patent expiration dates:
- March 13, 2029✓
- March 13, 2029
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Sulfoalkyl ether cyclodextrin compositions
Patent 8,410,077
Issued: April 2, 2013
Inventor(s): Antle Vincent
Assignee(s): CyDex Pharmaceuticals, Inc.SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
Patent expiration dates:
- March 13, 2029✓
- March 13, 2029
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Sulfoalkyl ether cyclodextrin compositions
Patent 9,200,088
Issued: December 1, 2015
Inventor(s): Antle Vincent D.
Assignee(s): Cydex Pharmaceuticals, Inc.SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
Patent expiration dates:
- March 13, 2029✓
- March 13, 2029
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Sulfoalkyl ether cyclodextrin compositions
Patent 9,750,822
Issued: September 5, 2017
Inventor(s): Antle Vincent D.
Assignee(s): Cydex Pharmaceuticals, Inc.SAE-CD compositions are provided, along with methods of making and using the same. The SAE-CD compositions comprise a sulfoalkyl ether cyclodextrin having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length.
Patent expiration dates:
- March 13, 2029✓
- March 13, 2029
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:
- June 16, 2025 - NEW PATIENT POPULATION
More about Zulresso (brexanolone)
- Zulresso consumer information
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous antidepressants
- Breastfeeding
Related treatment guides
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.