Under the settlement, India-based Dr. Reddy's will be able to sell generic versions Clarinex-D 12 Hour, Clarinex-D 24 Hour, and Clarinex Reditabs starting in 2012.
The deal settles all pending patent infringement actions filed by Kenilworth, N.J.-based Schering-Plough and Marlborough, Mass.-based Sepracor against Dr. Reddy's in U.S. District Court for the District of New Jersey. Specific terms of the deal have not been disclosed.
IPFinance writes: Politically the lure of cheaper drugs by increasing the supply of generics once the brand name drugs have come off patent is tempting. The other side of the coin is, however, the reduction of the return on the investment made by the pharmaceutical companies. These depend on the cash flowing in from successful drugs to fund their future research and development. Pushing for greater use of generic off-patent drugs may mean that the US government may have to increase funds for health research to counteract the reduction in R&D dollars spent by pharmaceutical companies.
The problem is the type of research the government would fund is not necessarily the type of research most-funded in the private sector.
Currently the approval process for generic biologics is not yet established. The characteristics of biologics means that the FDA demands full testing, rather than relying on data already on file. This hurdle means that few (if any) generic biologics have been approved - and that it will be some time before generic counterparts to brand name drugs appear.