Par Pharmaceutical Inc, a subsidiary of Pharmaceutical Resources Inc, announced that through its alliance partner Kali Laboratories Inc, an Abbreviated New Drug Application (ANDA) was filed with a paragraph IV certification for tramadol hydrochloride tablets with acetaminophen. Johnson and Johnson currently markets 37.5 mg tramadol HCl/325 mg acetaminophen tablets under the brand name Ultracet. Introduced in September 2001, Ultracet is indicated for the short-term (five days or less) management of acute pain. The product achieved U.S. sales of more than $40 million in the second quarter of 2002.
Kali Laboratories Inc submitted the ANDA to the U.S. Food and Drug Administration (FDA) in which Par believes was the first ANDA to be filed with a paragraph IV certification. According to current FDA practice, Par believes it may be entitled to exclusively market a generic tramadol/acetaminophen product for up to 180 days.
"We are very pleased to add another promising drug candidate to our ever expanding new product pipeline," said Scott Tarriff, president and chief executive officer. "Par has over twenty-five drugs awaiting FDA approval and, now with tramadol, as many as six of these may represent first-to-file opportunities. With more than 40 additional drugs currently in development, our Company possesses a new product pipeline that is among the most robust in our industry."