Because of Ipsen’s efforts in conducting clinical studies to support approval of Somatuline ED to treat GEP-NETs, FDA recognized that Ipsen was entitled to three years of “new drug product exclusivity,” meaning that FDA will not approve a “505(b)(2) [new drug] application or an ANDA [abbreviated new drug application] . . . that relies on the information supporting a change approved in the supplemental NDA” for a three-year period. 21 C.F.R. § 314.108(b)(5); see A.R. 10. In addition, because Somatuline ED’s new indication is to 1 “The NDC for a drug is a numeric code” that identifies the “labeler, product, and package size and type.”

After receiving FDA approval, a brand name drug developer is permitted to have exclusivity over the selling of the drug for a period of five years. See 21 C.F.R. § 314.108(b). Specifically, no other drug manufacturer is permitted to manufacture a drug with the same “active moiety,” which is defined as “the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordina- tion bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.”

This exclusivity applies regardless of whether the patents covering satraplatin had any remaining life. 21 U.S.C § 355(c)(3)(E)(ii) & 355(j)(5)(F)(ii); 21 C.F.R. § 314.108(b)(2). See also 2005 20-F at 47.

'° And a manufacturer will have a three-year period of exclusivity to market a drug for a new approved use, beginning on the date of the additional approval. 21 C.F.R. § 314.108(b)(5). Given the incentives other laws provide for researching new uses, a rational manufacturer is not going to stop pursuing a promising supplemental use simply because a generic equivalent is now beingsold for the original use.