SEC Filings

8-K
PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019
Entire Document
 

 

28 Zohydro ® ER Issued Patents IP Settlement Update • Teva/Actavis litigation: resolved via settlement in January 2018 under which Pernix will grant Actavis a license to begin selling a generic version of Zohydro ® ER on March 1, 2029 • Alvogen litigation: • Settlement with Alvogen with respect to 2019 patents and 9,132,096. • On August 27, 2018, Patents 9,265,760 and 9,339,499 were ruled to be infringed but invalid; however, this finding is subject to appeal • Zohydro ® ER with BeadTek ® is covered by 15 Orange Book listed patents, the latest expiring in 2034 • Patents on hepatic impairment data cover critical safety information relating to dosing of hepatically impaired patients. The patents possess a broad scope covering both generics and branded competitors U.S. Patent Appl. No. General Claim Scope Expiration Date Ownership 6,228,398 Multiparticulate modified release compositions 11/01/2019 In - Licensed from Recro 6,902,742 Multiparticulate modified release compositions 11/01/2019 In - Licensed from Recro 9,265,760 Critical safety information relating to dosing patients with hepatic impairment 7/25/2033 Solely owned by Pernix 9,339,499 Method of treating patients with hepatic impairment 7/25/2033 Solely owned by Pernix 9,326,982 Method of treating patients with hepatic impairment 7/25/2033 Solely owned by Pernix 9,333,201 Method of treating patients with hepatic impairment 7/25/2033 Solely owned by Pernix 9,421,200 Method of treating patients with hepatic impairment 7/25/2033 Solely owned by Pernix 9,433,619 Method of treating patients with hepatic impairment 7/25/2033 Solely owned by Pernix 9,610,286 Method of treating patients with hepatic impairment 7/25/2033 Solely owned by Pernix 10,028,946 Method of treating patients with hepatic impairment 7/25/2033 Solely owned by Pernix 9,132,096 Abuse deterrent compositions 9/12/2034 In - Licensed from Recro 9,452,163 Abuse deterrent compositions 9/12/2034 In - Licensed from Recro 9,486,451 Abuse deterrent compositions 9/12/2034 In - Licensed from Recro 9,713,611 Abuse deterrent compositions 9/12/2034 In - Licensed from Recro 10,092,559 Abuse deterrent compositions 9/12/2034 In - Licensed from Recro IP Status