Ranbaxy preserves exclusivity period for generic hypertension drug
WASHINGTON — A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.
Zuckerman Spaeder LLP said the U.S. District Court for the District of Columbia upheld a Food and Drug Administration decision protecting Ranbaxy’s market exclusivity for a generic version of Novartis’ drug Diovan (valsartan).
Ranbaxy asserted that as the first company to successfully challenge one of the patents covering Diovan, it was entitled to 180 days of market exclusivity in which to compete directly with the branded version, under the Hatch-Waxman Act of 1984, but another company had sought to challenge the exclusivity.
Greenstone launches authorized generic Dilantin Infatabs
PEAPACK, N.J. — Pfizer’s generics division has launched an authorized generic drug for treating epilepsy.
Greenstone announced the introduction of phenytoin tablets in the 50-mg strength, an authorized generic version of Pfizer’s Dilantin Infatabs.
Authorized generics are generic drugs marketed under their generic names at a reduced price, often through third-party companies under contract with the original drug’s manufacturer.
Dr. Reddy’s launches hair-loss drug
HYDERABAD, India — Dr. Reddy’s Labs has launched a generic drug for treating baldness, the Indian drug maker said.
Dr. Reddy’s announced the launch of finasteride tablets in the 1-mg strength, a generic version of Merck’s Propecia. As the first company to successfully file for approval of a generic version of the drug, Dr. Reddy’s is entitled to 180 days of market exclusivity in which to compete directly with the branded version.
Propecia had sales of about $136 million during the 12-month period that ended in October 2012, according to IMS Health.