A generic drug is a medication that has exactly the same active ingredient as the brand name drug and yields the same therapeutic effect. It is the same in dosing, safety, strength, quality, the way it works, the way it is taken, and the way it should be used. Generic drugs do not need to contain the same inactive ingredients as the brand name product.
However, a generic drug can only be marketed after the brand name drug's patent has expired, which may take up to 20 years after the patent holder’s drug is first filed with the U.S. Food and Drug Administration (FDA).
Generic drugs are usually much less expensive than brand name drugs once they reach the market.
A drug company develops new drugs as brand name drugs under patent protection. This protects their investment in drug research by giving the drug company the sole right to manufacture and sell the brand name drug while the patent is in effect.
When patents or other periods of exclusivity expire, other manufacturers can submit an abbreviated new drug application (ANDA) to the FDA for approval to market a generic version of the brand name drug.
Yes. The FDA must first approve all generic drugs before they are marketed. The FDA requires that generic drugs must be as high in quality, and as strong, pure and stable as brand name drugs. Generic drugs use the same active ingredients as brand name drugs and work the same way. They have the same risks and the same benefits as the brand name drugs.
Although generic drug active ingredients are chemically identical to their branded counterparts, they are typically sold at a cheaper price than the brand name drug.
Generics are less expensive because the drug manufacturer does not have to duplicate the original clinical trials for effectiveness and safety, which lowers the cost to bring the drug to market. Generics are not less expensive because they are lower in quality.
Usually. However, when a generic drug is first approved and marketed, costs may remain high (although less than the brand name drug) for 6 months because the FDA will give the first generic manufacturer a “180-day exclusivity period”. The “180-day exclusivity” is assigned to the generic manufacturer who is the first to file an ANDA and has done the additional work to get the generic drug to market.
This exclusivity allows the company to be the first -- and possibly only -- generic on the market for 6 months. Generic manufacturers may charge higher prices during this time because there is little to no other generic competition. Generic companies state that exclusivity allows them to recoup expenses related to being the first to bring a generic to market. Quite often this is a disadvantage to the consumer, who gets stuck with the higher priced generic for 6 months.
If more than one generic manufacturer files their ANDA at the FDA on the same day, these companies would share the 180-day exclusivity, which might lead to somewhat lower prices during the 180-day period due to competition, but possibly not as low as when several generics enter the market.