Vanda Pharms., Inc. v. FDA | Robins Kaplan LLP

Hetlioz(r) (tasimelteon)

Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. No. Feb. 13, 2025) (Chutkan, J. Hetlioz (r) (tasimelteon); U.S. patent No. , a medication for non-24-hour sleep-wake disorder.

Nature of the Case and Issue(s) Presented: Vanda filed a lawsuit against FDA, challenging the agency’s decision regarding the approval of generic versions of Hetlioz. Specifically, Vanda asserted that FDA violated the Administrative Procedure Act (“APA”) in approving an application by Teva to market the generic drug tasimelteon and in denying Plaintiff’s petition to revoke that approval.

Vanda argued that the FDA should have denied Teva’s application–and should have granted its petition to revoke the approval–for two reasons: (i) Teva violated the statutory same-label requirement due to certain changes it made to its label, which were not permitted by the exception for different manufacturers; and (ii) Teva’s changes to the label improperly altered the drug’s conditions of use. The court ruled that FDA won the case. FDA found that Teva’s omission of braille instructions was allowed because “the braille lettering was not required for Hetlioz’s approval, and Teva’s label conveys the same information in a different form.” The FDA allowed Teva to remove braille instructions because “the braille letters were not required for Hetlioz approval, and Teva’s label conveys that information in a completely different form.” The court disagreed and held that “dispense in original container” was not a condition of usage. The statement is intended to give pharmacies instructions on how to deliver the drug. It does not specify the “use” of the drug.