RULING PREVENTS MARKET ENTRY OF GENERIC COMPETITORS UNTIL 2024
WARREN, N.J., Jun 7, 2016 – MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that the District Court of Delaware has ruled in the Company’s favor in its litigation against Watson Pharmaceuticals (a division of Actavis Laboratories Inc.) and Par Pharmaceutical Companies, Inc. (a division of Endo International plc). The ruling upholds validity and enforceability of U.S. Patent No. 8,603,514 (the ‘514 Patent), a key MonoSol Rx patent related to Suboxone® Sublingual Film. It is expected to prevent generic buprenorphine and naloxone film products from entering the market prior to the patent’s expiration in 2024.
“We are extremely gratified by the Court’s decision, which demonstrates the strength of our intellectual property portfolio and the validity of our proprietary PharmFilm® technology,” said Keith Kendall, Chief Executive Officer of MonoSol Rx. “We are equally pleased for our partner, Indivior, whose product relies in part on our IP portfolio and the value PharmFilm® has brought to the Suboxone® franchise. We remain committed to aggressively asserting our IP rights and leveraging the value of that in additional PharmFilm® products. This is a significant victory for MonoSol Rx that further reinforces our leadership position in the area of film-based drug delivery.”
The court ruled that Watson and Par’s generic buprenorphine and naloxone product candidates, which sought FDA approval via the Abbreviated New Drug Application (ANDA) pathway, infringe the asserted claims of U.S. Patent No. 8,603,514, one of the Company’s Orange Book listed patents for Suboxone® Film, and that the asserted claims of US Patent No. 8,603,514 are valid and enforceable until its expiration in April 2024.
The Court further ruled that the asserted claims of U.S. Patent No. 8,017,150, which is set to expire in 2023, are valid, but that they are not infringed by Watson or Par’s ANDA Product. The Court found that the asserted claims of Indivior’s U.S. Patent No. 8,475,832 are invalid, but that certain of claims of this patent would be infringed by Watson and Par’s ANDA Products if they were valid.
A. Mark Schobel, Chief Innovation and Technology Officer of MonoSol Rx added, “This favorable ruling is an important milestone for MonoSol Rx and everyone who has contributed to the development of our PharmFilm® IP portfolio. The verdict significantly strengthens our competitive position and that of our existing and potential partners. We have invested significant resources in the development and patent protection of PharmFilm®, and the Court’s decision has further validated our intellectual property position.”
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm drug delivery technology to develop products that improve patient outcomes and address unmet needs. PharmFilm can benefit patients by improving the efficacy, safety, and convenience of pharmaceutical and over-the counter products. MonoSol Rx’s leadership in film drug delivery is supported by strong IP protection, a robust pipeline of prescription drug formulations, and two FDA-approved products — Suboxone® (buprenorphine and naloxone) sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases and other company information, visit www.monosolrx.com.