How long before generics can be made?

When patent protection for a brand-name drug expires, the U.S. Food and Drug Administration can approve a generic version of it for sale. The patent protection for a brand-name drug is usually 20 years from the date of the submission of the patent.

How long do brand name drug patents last?

The term of drug patents varies. The basic term for a patent is 20 years from the date of patent filing, which generally occurs several years before a drug is approved.

How long does a drug have exclusivity?

Once a new drug is approved, the FDA provides a guaranteed period during which a generic version cannot be approved, regardless of the time remaining on the new drug’s patent. This regulatory exclusivity typically runs for at least six years for new drugs.

How does a generic drug get approved?

Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug.

How do you bring a generic drug to the market?

All generic drugs in the United States are approved by the U.S. Food and Drug Administration (FDA). To get approval, a manufacturer must submit an Abbreviated New Drug Application (ANDA) and show that their generic drug is equivalent to the marketed brand name.

How do I get a generic drug approved?

To obtain approval of a generic drug, a company must submit an Abbreviated New Drug Application (ANDA) to FDA and prove that its product is the same as the brand-name drug in the ways described above, and that it is “bioequivalent,” meaning it gets to the part of the body where the drug works at the same time and in …

Why are generic drugs so much cheaper?

Generic medicines tend to cost less than their brand-name counterparts because they do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness.