Inpex files suit against Medicis over patent for Solodyn
HAYWARD, Calif. Impax Laboratories has filed a lawsuit against Medicis Pharmaceuticals in the U.S. District Court for the Northern District of California requesting a declaration that it does not infringe any valid claims of a patent for the anti-acne drug Solodyn with its application for a generic version.
Impax’s application does not contain any patent certification under Paragraph IV of the Hatch-Waxman amendments because no patents for the Solodyn product are listed in the Orange Book published by the Food and Drug Administration. Certain antibiotic products are not subject to these Hatch-Waxman procedures and, therefore, do not have patents listed in the Orange Book and are not subject to the patent certification requirements.
U.S. sales of Solodyn tablets were approximately $216.7 million in the 12 months ended Nov. 30, 2007. Impax filed for a generic application of Solodyn, minocycline hydrochloride extended-release tablets, in October 2007.
Celgene sees year-to-year revenue increase of more than 50 percent
WARREN, N.J. Celgene’s revenue increased by more than 50 percent in 2007 as compared to 2006. The growth was due to sales of its cancer drug Revlimid.
Revlimid is used in combination with the corticosteroid dexamethasone to treat multiple myeloma patients who have received at least one prior therapy. Net sales of the drug increased more than 140 percent in 2007 to nearly $775 million.
The company also reported good sales results for its skin disease treatment drug Thalomid, the chemotherapy drug Alkeran and the attention deficit hyperactivity disorder drugs Focalin XR and Ritalin and the Ritalin family of products.
The company expects revenue to increase more than 30 percent this year to approximately $1.8 billion and adjusted diluted earnings per share to increase approximately 45 percent up to $1.55.
Valeant divests Infergen rights to Three Rivers
ALISO VIEJO, Calif. Valeant Pharmaceuticals International has completed its divestment of the rights to its hepatitis C drug Infergen in the U.S. and Canada to Three Rivers Pharmaceuticals.
Under the terms of the agreement, Valeant received from Three Rivers an initial payment of about $70.8 million in cash and will receive up to $20.5 million in two noncontingent payments over the next 18 months.
The company had been looking to sell the drug since the third quarter of 2007 due to poor sales.