Aquestive Provides Business Update Following Suboxone Patent Ruling

11/20/18

Aquestive Therapeutics today received news that The U.S. Court of Appeals for the Federal Circuit overturned the preliminary injunction against Dr. Reddy's Laboratories ("DRL") as it relates to Suboxone® (buprenorphine / naloxone) Sublingual Film.

"While we are disappointed by the court's decision, we will continue to work with Indivior to vigorously pursue ongoing infringement cases against DRL and other generic manufacturers in order to protect the Suboxone patent portfolio. Today's action does nothing to change the validity and assertability of any of the patents in our portfolio," said Keith Kendall, CEO of Aquestive Therapeutics.

"It is important to remember that our proprietary products are the future of our business. We have made significant progress this year advancing our proprietary portfolio and late-stage pipeline. We recently launched Sympazan™ (clobazam) Oral Film and are progressing toward the regulatory filings of Libervant™ (diazepam) Buccal Film and Exservan™ (riluzole) Oral Film. These near-term products as well as the rest of our development pipeline represent a promising future for Aquestive as we work to deliver meaningful medicines that help simplify treatment for patients and caregivers with rare forms of epilepsy and complicated diseases."

About Aquestive Therapeutics

Aquestive Therapeutics is a specialty pharmaceutical company committed to identifying, developing and commercializing differentiated products to address unmet medical needs. Aquestive Therapeutics has a late-stage proprietary product pipeline focused on the treatment of CNS diseases, and is working to advance orally-administered complex molecules that it believes can be alternatives to invasively-administered standard of care therapies. As the leader in developing and delivering drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms.

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