As 2015 draws to a close, the year is on track to be one in which the value of the branded drugs losing their patent protection approaches an all-time high. The dozens of drugs that will have lost their patent protection this year are estimated to have global sales of $44 billion a year — the highest total since $53 billion worth of medications went off patent in 2012.
Rapidly rising prices for many generics, regulations that could restrict patients’ access to these medications, a Food and Drug Administration backlog in getting new drugs approved and market consolidation that is reducing competition are all making some wonder how much longer generics will continue to be affordable.
New Jersey Gov. Chris Christie this week signed legislation allowing pharmacists to subsistute FDA-approved biosimilar products for biologics, and Generic Pharmaceutical Association voiced its support for the move.
The Regulartory Affairs Professionals Society is reporting that as part of the recently passed budget deal that the president signed Monday, generics companies whose prices rise beyond the Average Manufacturer Price that’s adjusted for inflation will have to pay higher rebates. “The amount of the rebate specified in this paragraph for a rebate period, with respect to each dosage form and strength of a covered outpatient drug other than a single source drug or an innovator multiple source drug of a manufacturer, shall be increased in the manner that the rebate for a dosage form and strength of a single source drug or an innovator multiple source drug is increased,” the act says. (RAPS)