Generic Roszet Availability
Last updated on Apr 10, 2025.
Roszet is a brand name of ezetimibe/rosuvastatin, approved by the FDA in the following formulation(s):
ROSZET (ezetimibe; rosuvastatin calcium - tablet;oral)
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Manufacturer: ALTHERA PHARMS
Approval date: March 23, 2021
Strength(s): 10MG;EQ 5MG BASE (discontinued) [RLD], 10MG;EQ 10MG BASE (discontinued) [RLD], 10MG;EQ 20MG BASE (discontinued) [RLD], 10MG;EQ 40MG BASE (discontinued) [RLD]
All of the above formulations have been discontinued.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Roszet. 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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Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
Patent 10,376,470
Issued: August 13, 2019
Inventor(s): Dias Marie Charmaine & Ramani Chandir
Assignee(s): Althera Life Sciences, LLCSolid dosage formulations containing a combination of rosuvastatin and ezetimibe, as well as methods of making such solid dosage forms and method of treating patients with fixed combination solid dosage forms of rosuvastatin and ezetimibe are provided here.
Patent expiration dates:
- May 1, 2033✓✓
- May 1, 2033
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Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
Patent 9,763,885
Issued: September 19, 2017
Inventor(s): Dias Marie Charmaine
Assignee(s): Althera Laboratories Ltd.The present invention is an orally consumed fixed combination formulation of both rosuvastatin and ezetimibe in one tablet that is expected to have the same Area Under Curve as two active ingredients taken together individually orally, and pharmaceutically acceptable additives suitable for the preparation. In preferred embodiments of this invention, the rosuvastatin is in the form of rosuvastatin calcium and the pharmaceutically acceptable additives are selected from diluents, disintegrants, glidants, lubricants, colorants and combinations thereof.
Patent expiration dates:
- May 1, 2033✓✓
- May 1, 2033
More about Roszet (ezetimibe / rosuvastatin)
- Roszet consumer information
- Check interactions
- Compare alternatives
- Imprints, shape & color data
- Latest FDA alerts (1)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: antihyperlipidemic combinations
- En español
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.