Teva Pharmaceutical Industries has been told to sell certain assets by US antitrust authorities in return for approval of its $6.80 billion acquisition.
The US Federal Trade Commission says the Israeli drugmaker must divest the rights and assets related to its generic versions of the cancer pain drug Actiq (fentanyl) and the muscle relaxant Amrix (extended-release cyclobenzaprine) to rival company Par Pharmaceuticals. The divestitures must be completed within 10 days of the acquisition closing, which is likely in the next week, subject to approval by the European Commission.
Annual revenues in the USA for Actiq and equivalent generic products are $173 million, while branded sales of Amrix are approximately $125 million a year.
In addition, the go-ahead from the FTC requires Teva to grant non-exclusive US rights to an undisclosed company to market a generic version of Cephalon's sleep disorder blockbuster Provigil (modafinil) which had sales in the USA of $1.1 billion and is set to go off-patent next year. Teva will also be required to enter into a supply agreement to provide Par with generic Provigil in the USA for one year, allowing the latter company to compete with a copycat product during the 180-day exclusivity period. That part of the deal includes an option to extend the supply pact for an additional year.
Richard Feinstein, director of the FTC’s Bureau of Competition, said "this settlement preserves competitive markets for current generic drugs, which are key to holding down the cost of healthcare for consumers". He added that "it also ensures there will be competition among generic drugs introduced in the future".