Controlled-release can deliver for generics firms, says Espicom
The study, “Emerging opportunities in controlled-release generic drugs,” claims the $15bn (€10.5bn) worth of CR medicines due to go off-patent in the medium term will be an irresistible opportunity for larger generics firms.
Espicom argues that although pharma firms are “[looking] at CR delivery earlier in the product life-cycle” and, in some cases, launch CR versions ahead of patent expiry, such efforts are often the subject of challenges by generics firms keen to compete in the market.
The authors cites $3bn a year selling Effexor XR (venlafaxine) as an example of a CR product that has faced generic competition. They explain that although this version of the drug is protected in the US, a number of generics firms have filed Paragraph IV certifications under the Hatch-Waxman act.
At present several generics firms, including Sandoz, Wockhardt and Biovail, are the subject of Wyeth lawsuits for seeking Food and Drug Administration (FDA) approval to sell CR versions of venlafaxine in the US.
They authors also note that Wyeth has already settled litigation with Teva, Impax, Lupin and Anchen, all of which can introduce non-branded versions of controlled release venlafaxine over the next few years.
Lack of CR drug competition among generics firms
Espicom went on to suggest, however, that the opening up of the CR market will be a windfall for established generics firms with effective delivery technologies rather than smaller non-branded drugmakers that lack the funds to develop such platforms.
They authors argue that technical barriers to the development of CR drugs mean that firms able to produce them “will generally have fewer competitors in the marketplace and, therefore, will attract higher prices and greater revenue opportunities than the highly competitive instant-release formulations.”
