PRINCETON, N.J. Sandoz has opened what it calls a key site for the development of generic drugs in New Jersey, the generic drug arm of Novartis said Friday.
Sandoz said the development center, in the town of East Hanover, on a campus owned by Novartis, would place an emphasis on developing generic drugs for which it can be the first to file for regulatory approval. Under the Hatch-Waxman Act of 1984, the first company to file for approval of a generic drug with the Food and Drug Administration is entitled to six months’ market exclusivity in which to compete directly with the branded version. In recent years, the provision, combined with patent expiries on a number of blockbuster drugs, has allowed generic drug makers to reap enormous profits and grow significantly.
“We are pleased to introduce a new Sandoz development center on the Novartis East Hanover campus, a best-in-class facility that will enable us to further build on our strong internal development capability,” Sandoz president Don DeGolyer stated. “Innovative development is at the heart of our strategy, and this new center should enable us to capitalize on synergies within Novartis Pharmaceuticals Corp., as well as benefit from top talent here in New Jersey.”