In March 2000, Knoll Pharmaceuticals and Abbott Laboratories, an American health care company, announced a co-promotion agreement for Vicoprofen, in which Abbott would promote Vicoprofen to its network of buyers, including physicians, hospitals, and surgical centers. In June 2002, Abbott Laboratories, paid $6.9 billion to acquire the entire Knoll pharmaceutical unit from BASF, including Vicoprofen. DEA classification
Vicoprofen was originally approved as a schedule III drug, but was later reclassified to a schedule II drug based on the DEA reclassification of hydrocodone containing products effective 6 October 2014. Research
The new drug application for Vicoprofen was approved based on data from both single and multiple dose analgesia trials. The single dose analgesia studies occurred in multiple surgical settings, including dental, back, and abdominal/gynecologic surgery in the U.S. and Puerto Rico. There were 1,537 patients enrolled over all trials, with 79% of the participants being female. There were 10 single dose analgesia trials included in the new drug application. All studies were similarly designed: after completion of a procedure in which pain was rated as moderate or severe, patients would be randomized into various treatment groups. The treatment groups included: ibuprofen only, hydrocodone only, Vicoprofen (hydrocodone/ibuprofen), and placebo. The participants pain would then be tracked over the next several hours by the self reporting of pain scores.There were four multiple dose trials included in the new drug application. These studies were all completed in the U.S., in settings including burn unit, post-operatively, and chronic pain settings.
Vicoprofen tablets were initially formulated and packaged by Knoll, with ibuprofen supplied by Albemarle Corporation and hydrocodone supplied by Mallinckrodt Pharmaceuticals.The validity of Knolls patent on Vicoprofen has been challenged in federal court. In September 2002, the U.S. District Court for the Norther District of Illinois granted a motion of invalidity filed by Teva Pharmaceuticals against Knolls patent on Vicoprofen, ruling the patent was invalid as obvious. This ruling paved the way for Tevas abbreviated new drug application to be approved by the FDA which would allow them to manufacture and market their own generic. Knoll appealed the decision. In April 2003, Teva announced that its abbreviated new drug application had been approved by the FDA, and its generic would begin shipping immediately. In May 2004, the United States Court of Appeals for the Federal Circuit vacated the previous judgment by the U.S. District Court for the Northern District of Illinois, and the case was remanded back for further court proceedings. Teva continued to sell its generic during this time. The patent for Vicoprofen expired on 18 December 2004, officially opening the drug to generic manufacture. In July 2016, the FDA approved another generic equivalent, manufactured by Aurobindo Pharma Limited. Ownership and promotion
Knoll pharmaceuticals, originally founded in Germany in 1886, became a subsidiary of BASF (a German chemical company) in 1975. It was under their control when Vicoprofen was originally developed and approved.