Products in conventional dosage forms not presenting bioequivalence problems. 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.

A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.Ī Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. 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.Įxclusivity 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. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation.

Ask your health care provider for advice if you are unsure about the online purchase of any medication.Ī drug patent is assigned by the U.S. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. These medications may be counterfeit and potentially unsafe. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Drisdol. The following products are equivalent to Drisdol: ergocalciferol capsule oral Has a generic version of Drisdol been approved? Drisdol is a brand name of ergocalciferol, approved by the FDA in the following formulation(s): DRISDOL (ergocalciferol - capsule oral)

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