Watson Pharmaceuticals has confirmed that Watson Laboratories has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Hydromorphone Hydrochloride extended-release tablets, 8mg, 12mg, and 16mg.
Hydromorphone Hydrochloride extended-release tablets are a generic version of Mallinckrodt’s Exalgo tablets, which are indicated for once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
Based on available information, Watson believes it may be a ‘first applicant’ to file an ANDA for the 8mg, 12 mg, and 16 mg generic versions of Exalgo and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
Mallinckrodt’s lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson’s ANDA until 29 April 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.