Litigation

9 Months Ended

Sep. 30, 2021

Commitments and Contingencies Disclosure [Abstract]

Litigation

Litigation

On July 21, 2021, we received a letter dated July 20, 2021, notifying us that Apotex Inc. and Apotex Corp. (collectively, “Apotex”) submitted to FDA an abbreviated new drug application (“ANDA”) for a generic version of 2.2 mg base/ml Fintepla (fenfluramine hydrochloride) that included “Paragraph IV” certifications (pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)) with respect to two of our patents covering Fintepla, U.S. Patent Nos. 10,603,290, expiration date August 2, 2037; and 10,452,815, expiration date June 29, 2038. These patents are listed in FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, for Fintepla. The letter included a statement setting forth the basis for Apotex’s opinion that these patents are invalid and/or will not be infringed by the manufacture, use or sale of Apotex’s fenfluramine hydrochloride oral solution, 2.2 mg base/ml product. On August 30, 2021, we filed a complaint against Apotex Inc. and Apotex Corp. for infringement based on these Paragraph IV certifications. On October 13, 2021, we received a letter dated October 12, 2021 notifying us that Apotex had amended its ANDA and submitted additional Paragraph IV certifications with respect to two additional Orange Book-listed patents covering Fintepla, U.S. Patent Nos. 10,950,331, expiration date September 28, 2035; and 10,947,183, expiration date December 20, 2036. The letter included a statement setting forth the basis for Apotex’s opinion that these two additional patents are also invalid and/or will not be infringed by the manufacture, use or sale of Apotex’s fenfluramine hydrochloride oral solution, 2.2 mg base/ml product. On October 28, 2021, we filed a second complaint against Apotex Inc. and Apotex Corp. for infringement based on these additional paragraph IV certifications.

On August 31, 2021, we received a letter dated August 27, 2021 notifying us that Lupin Limited (“Lupin”) submitted to FDA an abbreviated new drug application (“ANDA”) for a generic version of 2.2 mg base/ml Fintepla

(fenfluramine hydrochloride) that contains “Paragraph IV” certifications (pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)) with respect to seven of our patents covering Fintepla, U.S. Patent Nos. 9,549,909, expiration date May 3, 2033; 9,603,814, expiration date May 3, 2033; 9,603,815, expiration date May 3, 2033; 9,610,260, expiration date May 3, 2033; 10,478,441, expiration date May 3, 2033; 10,478,442, expiration date May 3, 2033; and 10,947,183, expiration date December 20, 2036 (collectively, "the Asserted Patents"). These patents are listed in FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, for Fintepla. The letter included a statement setting forth the basis for Apotex’s opinion that these patents are invalid and/or will not be infringed by the manufacture, use or sale of Lupin’s fenfluramine hydrochloride oral solution, 2.2 mg base/ml product. On October 6, 2021, we filed a complaint against Lupin for infringement based on the Paragraph IV certifications.

Fintepla has Orphan Drug exclusivity, which prevents FDA from approving an ANDA referencing Fintepla until June 25, 2027. We intend to vigorously enforce our intellectual property rights relating to Fintepla. We cannot predict the ultimate outcome of these actions, and we may spend significant resources enforcing and defending these patents. If we are unsuccessful, some or all of our claims in the patents may be narrowed or invalidated and the patent protection for our products could be shortened, allowing for the sale of generic versions of these products earlier than their patent expiration, which could have a significant negative effect on our revenues and results of operations.