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Insys Therapeutics Reports Listing of US Patents Covering SUBSYS Use, Formulation in FDA's Orange Book

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Insys Therapeutics, Inc. (NASDAQ: INSY), a pharmaceutical company focused on commercial-stage specialty pharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has listed U.S. Patent Nos. 8,486,972 ('972 patent) and 8,486,973 ('973 patent) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. Both of these patents cover SUBSYS brand fentanyl sold by Insys and will expire no sooner than 2027. The '972 patent covers the SUBSYS sublingual fentanyl spray formulation, while the '973 patent covers the use of the SUBSYS sublingual fentanyl spray for the treatment of pain. The proprietary formulation of the '972 patent is useful for delivering fentanyl directly to the sublingual mucosa to achieve appreciable plasma concentration levels within 5 minutes. This unique formulation differs from other fentanyl formulations in that it is readily absorbed bringing quick and effective pain relief to the patient without the need for injections or IVs. The methods included in the '973 patent cover the treatment of a patient suffering from pain by administration of the formulation described in the '972 patent.

Important SUBSYS Safety Information

-- Due to the risk of fatal respiratory depression, SUBSYS is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. -- Keep out of reach of children. -- Use with CYP3A4 inhibitors may cause fatal respiratory depression. -- When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to SUBSYS. -- When dispensing, do not substitute with any other fentanyl products. -- Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. -- SUBSYS is available only through a restricted program called the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

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