Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶10

Once the FDA has approved a new drug, federal law authorizes other manufacturers to seek approval for marketing generic versions. In particular, the Hatch-Waxman Amendments “allow a generic competitor to file an abbreviated new drug application (ANDA) piggy-backing on the brand’s NDA.” Id., at 404–405 (citing §§355(j)(2)(A)(ii), (iv) (2012 ed.)). “[T]he typical ANDA shows that the generic drug has the same active ingredients as, and is biologically equivalent to, the brand-name drug.” Id., at 405. The generic manufacturer can thereby “avoid the costly and time- consuming studies required for a pioneer drug.” Eli Lilly & Co. v. Medtronic, Inc., 496 U. S. 661, 676 (1990).

slip opinion
Source edition
Passage preview. Read in context for the complete text, notes and references.