How many months of exclusive rights to sell a generic drug is granted to the first applicant who shows that the generic is equivalent?

The first applicant who demonstrates that a generic drug is therapeutically equivalent to a brand-name product is granted six months of exclusive marketing rights. This provision is part of the Drug Approval Modernization Act, which incentivizes the development of generic drugs by providing a temporary monopoly for the first applicant that successfully submits an Abbreviated New Drug Application (ANDA).

The six-month exclusivity period not only delays the approval of subsequent generic versions but also allows the first applicant to recoup some of the research and development costs associated with bringing the generic to market. This exclusivity applies specifically to the first applicant who meets the regulatory requirements for safety and efficacy, thus encouraging competition and eventual market access once the exclusivity period expires.

This knowledge is crucial for understanding the competitive landscape of the pharmaceutical market and the incentives designed to foster the entry of generics, which ultimately benefit consumers through reduced medication costs.