After a series of legal actions and acrimonious maneuverings, it looks like Pfizer’s workhorse medication Celebrex will finally be available for consumers in its generic form, celecoxib. Both the drug manufacturers and distributors Mylan and Teva will be able to grab a share of this multi-billion dollar pie by no later than the end of the year.
For those not familiar with this product, Celebrex (celecoxib) is a non-steroid anti-inflammatory drug (NSAID) prescribed to fight pain, particularly that of arthritis and ankylosing spondylitis (an inflammatory disease affecting the vertebrae in the spine).
At first, it looked as if Pfizer had staved off the competition when, in March of 2013, a key patent was reissued, allowing them to continue exclusive rights until the end of 2015. But in March of this year, that order was reversed, and the FDA started to permit generic manufacture and distribution.
The bulk of the generic market will fall initially to Teva, who was granted access by Pfizer to the three largest doses (100, 200, and 400 mg) and can put them on the market at any time between now and December, with exclusive rights for approximately six months.
The Mylan contract allows it marketing rights to the smallest dose (50 mg) for the same length of time – a situation they are not pleased with and they have taken addition legal action to overturn. However, a decision on this has not yet been issued, but by the end of the year they will be able to market all four doses.
Actavis was also involved in the settlement, but there is no word on when they will begin production.
While the fight about who can market what and have the largest share for the first six months continues, there will be no delaying the release of celecoxib. Following this first six-month period, the generic base will expand as more companies will be allowed to manufacture the generic.
While no specific launch date has been set by either Teva or Mylan, it is expected that distribution will begin immediately now that the legal machinations have either been resolved or are in their final stages.
For consumers, this is a tremendous boon. Celebrex has been Pfizer’s second most popular product (trailing only Lipitor), and was responsible for generating almost three billion in total sales last year. To some extent, this is not surprising given that prices for this medication start at $130 for sixty 50 mg capsules and push $700 for the same number at 400 mg. Once the generic formulations hit the market, however, it is expected that prices for this popular medication will begin their gradual drop by anywhere from 30 to 80 percent.
For more generic alternatives to brand name medications, visit our Generic Medications & Discounts page. There you can view the top 10 prescription drugs with generic equivalents and view other generic drug information.