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.
Breastfeeding
Hydrocodone and ibuprofen are excreted in breast milk, so appropriate caution should be taken when prescribing to breastfeeding mothers. Special populations
There is no evidence to support altered pharmacokinetic properties due to differences in gender or age. However, this drug combination has not been tested in children. Adverse effects
The side effects for hydrocodone/ibuprofen are a combination of the side effects of the component drugs. Side effects experienced in more than 10% of the population taking the drug include: headache, drowsiness, dizziness, constipation, nausea, and dyspepsia. Pharmacology
Pharmacokinetics
The two active components of the drug, ibuprofen and hydrocodone, do not affect each others absorption characteristics or other pharmacokinetic parameters. After an oral dose, the peak level of hydrocodone in the blood is reached 1.7 hours after administration. The blood levels of ibuprofen peak 1.8 hours after oral administration. History
Discovery and development
The patent for Vicoprofen was filed in December 1984, and U.S. patent number 4,587,252 was granted in May 1986. Although ibuprofen and hydrocodone were already available on the market at this time, the fact that they had never been supplied together in a single formulation required approval from the FDA as if it were a new drug. Knoll filed an investigational new drug application on 30 December 1986. A new drug application was later filed by Knoll on 25 April 1996, and received final approval from the FDA on 23 September 1997.