Teva Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration (FDA) has approved the Company's ANDA for Oxycodone Hydrochloride Extended Release Tablets, 80 mg. As the first company to file an ANDA with a Paragraph IV patent certification for the 80 mg strength of Oxycodone Hydrochloride ER Tablets, Teva has been awarded 180 days marketing exclusivity for this product. A launch date has not yet been determined.
Oxycodone Hydrochloride ER Tablets are the AB-rated generic equivalent of Purdue Pharma's OxyContin Controlled Release Tablets, 80 mg. This product is indicated for the management of moderate to severe pain when a continuous, around-the-clock, analgesic is needed for an extended period of time.
Branded annual sales of this strength are approximately $700 million.