What must a pharmaceutical company submit to the FDA to market a generic version of an expired patent drug?

To market a generic version of a drug whose patent has expired, a pharmaceutical company must submit an Abbreviated New Drug Application (ANDA) to the FDA. The ANDA process allows manufacturers to demonstrate that their generic product is bioequivalent to the branded drug without the need for extensive clinical trials that are usually required for new drugs. This is specifically designed for generics to facilitate a quicker and less costly path to market, assuming the original drug is already approved and provides a sufficient reference for safety and efficacy.

The requirements for an ANDA submission include data that demonstrate the generic drug's similarity in dosage form, strength, and route of administration to the original branded drug, along with demonstrating that it meets all relevant quality and labeling standards. This streamlined process encourages competition in the pharmaceutical market, leading to lower drug prices for consumers.

Other submission types mentioned do not fulfill the criteria for bringing a generic drug to market. A New Drug Application (NDA) is used for new drugs and includes more comprehensive clinical data. An Investigational New Drug (IND) application is intended for drugs that have not yet been tested in humans, to begin clinical trials. The 505(b)(2) application is a hybrid approach for drugs that may rely on existing studies for