Acura Pharmaceuticals is engaged in research, development and manufacture of pharmaceutical products for the treatment of severe pain using its Aversion technology. The company's portfolio of pipeline products includes opioid analgesics such as Acurox, Acuracet and Vycavert tablets. Sandoz develops, manufactures and markets generic drugs as well as pharmaceutical and biotechnological active ingredients.
The patentUS7510726involved in suit is currentlyassigned[i]to Acura (source:MaxVal’s Assignment Database). The patent entitled Methods and compositions for deterring abuse of opioid containing dosage forms was issued on March 31, 2009 and expires[ii] on November 26, 2023.
Pfizer and partner Acura received US Food and Drug Administration (FDA) approval for New Drug Application[iii] (NDA) no. 20-2080 for Oxecta® (formerly known as Acurox) (source: Patent Marker) on June 17, 2011. Oxecta became a part of Pfizer’s portfolio following its acquisition of King Pharmaceuticals. Oxecta was developed under anagreement for the licensing, development, and commercialization of immediaterelease (IR) pain medicines utilizing Acura's Aversion (abuse-deterrent) technology. The abuse-deterrenttechnology has been designed to discourage opioid abuse and misuse throughcommon ways of tampering.
Oxectais used in the treatment of chronic pain. It belongs to the group of medicinescalled narcotic analgesics (pain medicines). Oxecta 5 and 7.5 mg as shown infig.1 have a high potential for abuse. The drug is currently accepted for medicaluse with severe restrictions. Defendant with the Abbreviated New Drug Application (ANDA) no. 20-4155 also seeks FDA approval to market Sandoz’s Oxycodone HCl Tablets that is covered by the ‘726 patent.
Fig. 1 Oxecta 5 mg and 7.5 mg
Plaintiff has filed suit against 3 other companies for the same patent. The case details are listed below: