FDA Clears Par Pharma to Sell Generic Ultracet

Par Pharmaceutical

(PRX)

subsidiary Kali Laboratories received approval to market a generic version of

Johnson & Johnson's

(PRX)

painkiller Ultracet.

The Spring Valley, N.Y., generic-drug maker received final approval from the Food and Drug Administration of an abbreviated new drug application, the company announced Friday. The drug, indicated for short-term use for acute pain, combines opioid painkiller tramadol hydrochloride with acetaminophen, known by the Johnson & Johnson brand name Tylenol.

The company estimates Ultracet brings Johnson & Johnson $350 million in annual sales. Par will have 180 days of exclusive marketing rights to the generic version.

Kali is involved in a patent infringement lawsuit with Ortho-McNeil Pharmaceutical, part of the Johnson & Johnson family. Kali calls the patent for Ultracet invalid and unenforceable.

Par shares were up 31 cents, or 0.9%, to $33.94. Johnson & Johnson shares were up 23 cents, or 0.3%, to $68.52.