Federal Circuit Upholds Nuedexta Patent Injunction, Vacates Zero-Dollar Bond
Federal Circuit affirms injunction against generic Nuedexta but rejects zero-dollar bond waiver.
Why it matters: This ruling clarifies judicial expectations for bond requirements in patent injunctions, a key issue for IP litigators and in-house counsel managing patent risk and litigation strategy.
- Federal Circuit affirmed Delaware District Court’s preliminary injunction preventing Hetero Labs’ generic Nuedexta launch.
- Court vacated district court’s waiver of the injunction bond, citing Third Circuit law requiring bond except in limited cases.
- Nuedexta's patent ('282) expires August 13, 2026; generic launch was planned for July 10, 2025.
- District court granted injunction on July 23, 2025, without requiring a bond.
On July 1, 2026, the U.S. Court of Appeals for the Federal Circuit issued its decision in Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited, affirming a preliminary injunction that blocked Hetero Labs from launching a generic version of Nuedexta.
Nuedexta is a branded pharmaceutical drug combining 20 mg of dextromethorphan hydrobromide with 10 mg of quinidine sulfate, covered by the '282 patent set to expire on August 13, 2026.
The injunction was granted by the District of Delaware on July 23, 2025, after Hetero Labs announced plans to launch a competing generic product on or after July 10, 2025.
However, the Federal Circuit vacated the district court’s waiver of the preliminary injunction bond, reasoning that under Third Circuit precedent, waiving bond requirements is acceptable only in limited circumstances. The higher court found the district court “abused its discretion” by issuing the injunction without requiring any bond.
This decision underscores the judiciary’s careful balancing of protecting patent holders through injunctions while shielding allegedly infringing parties from undue financial harm if the injunction proves wrongful.
By the numbers:
- 282 patent expires August 13, 2026 — patent protection for Nuedexta
- July 23, 2025 — date of preliminary injunction granting
- July 10, 2025 — intended generic launch date by Hetero Labs