Generic Agamree Availability
Last updated on Mar 13, 2025.
Agamree is a brand name of vamorolone, approved by the FDA in the following formulation(s):
AGAMREE (vamorolone - suspension;oral)
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Manufacturer: CATALYST PHARMS
Approval date: October 26, 2023
Strength(s): 40MG/ML [RLD]
Is there a generic version of Agamree available?
No. There is currently no therapeutically equivalent version of Agamree available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Agamree. 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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Non-hormonal steroid modulators of NF-kB for treatment of disease
Patent 10,857,161
Issued: December 8, 2020
Inventor(s): McCall John M. & Hoffman Eric & Nagaraju Kanneboyina
Assignee(s): ReveraGen BioPharma, Inc.Provided herein is a pharmaceutical composition comprising a compound having the structural formula
Patent expiration dates:
- May 28, 2029✓✓
- May 28, 2029
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Patent 11,382,922
Patent expiration dates:
- July 16, 2040✓✓
- July 16, 2040
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Patent 11,471,471
Patent expiration dates:
- March 17, 2040✓
- March 17, 2040
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Patent 11,690,853
Patent expiration dates:
- March 7, 2033✓
- March 7, 2033
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Patent 11,833,159
Patent expiration dates:
- May 28, 2029✓
- May 28, 2029
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Patent 12,201,639
Patent expiration dates:
- March 17, 2040✓✓✓
- March 17, 2040
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Non-hormonal steroid modulators of NF-κB for treatment of disease
Patent 8,334,279
Issued: December 18, 2012
Inventor(s): McCall John M. & Hoffman Eric & Nagaraju Kanneboyina
Assignee(s): Validus GeneticsThe present invention relates to compounds and methods which may be useful as treatments of neuromuscular diseases such as muscular dystrophy, and as inhibitors of NF-κB for the treatment or prevention of muscular wasting disease, including muscular dystrophy.
Patent expiration dates:
- May 28, 2029✓
- May 28, 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:
- October 26, 2028 - NEW CHEMICAL ENTITY
- October 26, 2030 - TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 2 YEARS OF AGE AND OLDER
More about Agamree (vamorolone)
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- Dosage information
- During pregnancy
- FDA approval history
- Drug class: glucocorticoids
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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.