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Assertio Holdings, Inc. Announces FDA Orange Book Listing for New Sympazan® Oral Film Patent
Extends Intellectual Property Protections to 2039 LAKE FOREST, Ill., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”)
About this update from Assertio Holdings, Inc.
[{"type":"text","content":"Extends Intellectual Property Protections to 2039\nLAKE FOREST, Ill., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today announced that U.S. Patent, No. 11541002 for Sympazan® oral film is now listed in the U.S. Food and Drug Administration (“FDA”) publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The patent, which is valid until 2039, is assigned to Aquestive Therapeutics, Inc. and exclusively licensed to Assertio. It covers an oral film for delivering clobazam and methods for using the film to treat epilepsy and/or seizures. Aquestive will continue to prosecute additional US patent application(s) to further strengthen the portfolio on this product. “We are pleased to see this patent listed in the Orange Book, as originally anticipated in our Sympazan licensing agreement with Aquestive. This patent is complementary to two other Sympazan patents already listed in the Orange Book and extends patent coverage until 2039 for this innovative and attractive oral film delivery system for clobazam,” Dan Peisert, President and Chief Executive Officer of Assertio. “Sympazan exemplifies the type of longer duration assets we are seeking to add to the portfolio as we continue to diversify and expand our platform,” said Vanessa Fox, Vice President, Business Development and Commercial Analytics. “We continue to work a robust pipeline of business development projects in support of our goal to add $50 million of incremental gross profit by 2024, of which we have now secured $18 million from the combination of our Otrexup and Sympazan transactions, both of which include notable growth opportunities.” About Sympazan Trade NameSympazan® (clobazam) oral film formulationIndicationFor the adjunctive treatment of seizures associated with Lennox‐Gastaut Syndrome (LGS) in patients aged 2 years of age or olderLast to Expire Orange Book Listed PatentSeptember 2039Trailing 12 Months Revenue Ended 6/30/22Approximately $9.5 Million WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, ...