The company will have 180 days of marketing exclusivity.
Teva (Nasdaq: TEVA) has announced that the U S Food and Drug Administration has granted final approval for the company's ANDA for Fenofibrate Capsules (Micronized), 67 mg.
The 134 mg and 200 mg strengths were approved April 9, 2002 following a favorable ruling on a motion for summary judgement. Approval of the 67 mg strength was granted upon the expiration of the 30-month clock which resulted from patent litigation. As the first company to file an ANDA with a Paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity for this product. Therefore, this exclusivity period will begin upon Teva's first commercial marketing of the 67 mg strength.
Fenofibrate Capsules (Micronized) are the AB-rated generic equivalent of Abbott's Tricor Capsules, Micronized, for the treatment of patients with very high elevations of serum triglyceride levels. Annual sales of the 67 mg strength of the brand product are approximately $14 million.
Teva shares closed at $65.41, representing a gain of 0.7%, on the Nasdaq exchange yesterday.
Published by Globes [online] - www.globes.co.il - on September 5, 2002