Hetlioz® (tasimelteon)
Case Name: Vanda Pharms., Inc. v. FDA, Civ. No. 23-280 (TSC), 2025 WL 485401 (D.D.C. Feb. 13, 2025) (Chutkan, J.)
Drug Product and Patent(s)-in-Suit: Hetlioz® (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. Both parties moved for summary judgment, and the court ruled in FDA’s favor.
Why FDA Prevailed: On the first point, Vanda argued that Teva’s label improperly omitted braille instructions for use, which are present on Vanda’s label. More specifically, Vanda argued that a generic manufacturer can only alter its label to include “changes required ... because the new drug and the [pioneer] drug are produced or distributed by different manufacturers.” If Vanda’s view were to be adopted, label changes would only be allowed if “it would be impossible for a generic manufacturer to use the same labeling as the brand manufacturer.” The court rejected this view, finding that changes are permitted if they result from the generic manufacturer's otherwise permissible design choices and are shown to maintain the drug's safety and effectiveness. In the context of Teva’s omission of braille instructions, the FDA found that such a change was permitted because “the braille lettering was not required for Hetlioz’s approval, and Teva’s label conveys the same information in a different form.”
On the second point, Vanda argued that its label included the printed statement “Dispense in original container” and that “Teva’s label unlawfully omitted that statement” because such a statement is a “condition of use” that must be included for approval. The court disagreed, finding that, as statutorily defined, a “condition of use” refers to “how, to whom, and for what purpose the drug is administered.” Under this definition, the court held that “Dispense in original container” is not a condition of use. The statement gives instructions to pharmacies for delivering the drug; it does not provide any direction for the drug’s actual “use.”
