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.

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.

Trademark laws do not allow generic drugs to look exactly like the brand name drug. However, the generic drug must have the same active ingredients. Colors, flavors, and certain other inactive ingredients may be different but the effectiveness of the drug remains the same.

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.

No. New drugs are developed under patent protection, and most drug patents are protected for 20 years after FDA filing. However, it may take many years to research and get the brand name drug to market. When the patent gets closer to expiration, other drug companies apply to the FDA for approval to start selling the generic version of the drug.

“Branded generics” are just like they sound — generic drugs that have a brand name. These drugs are developed either by a generic drug company or the original manufacturer after the patent expires for the original product. The branded generic name is proprietary to (owned by) the company.

IMS Health defines a branded generic as either a prescription product that is a novel dosage form of an off-patent product produced by a manufacturer that is not the originator of the molecule, or a molecule copy of an off-patent product with a trade name. The branded generic must be bioequivalent to the original brand product.

Branded generics, like regular generics, can only be developed after the patent expiration of the original brand name drug. However, branded generics can be made by any pharmaceutical company willing to submit the abbreviated new drug application (ANDA) to the FDA. In fact, many large pharmaceutical companies that typically only create brand name drugs are now acquiring generic companies, or spinning one off, to delve into this lucrative business. According to the Generic Pharmaceutical Association, brand name companies make about 50% of the generic drugs on the market.

No, a biosimilar is not considered a “generic” in the same way that a traditional drug is determined to be a generic. A biosimilar is a biological product that is “highly similar” to a U.S.-licensed reference biological and which has no clinically meaningful differences between the biological product and the original branded product in terms of safety, purity, and potency of the product. The FDA approval process for biologics and biosimilars is somewhat different.