Dr Reddy's Laboratories Ltd has announced that the US Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for fexofenadine hydrochloride tablets 30mg, 60mg and 180mg.
Fexofenadine hydrochloride is the AB-rated generic equivalent of Sanofi-Aventis Allegra. Allegra. It is indicated for the relief of symptoms associated with seasonal allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children six years of age and older.
The product had annual US brand sales of approximately $1.4 billion last year. The company will commence commercial marketing of the product immediately.
In September 2002, Dr Reddy's had filed the ANDA for fexofenadine hydrochloride tablets 30mg, 60mg and 180mg with a Para IV certification on all orange book patents. It was granted summary judgment for three patents, while five remained under litigation. The litigation is pending at the US District Court for the District of New Jersey. No date has been set for trial.
The 30-month period identified in section 505(j)(5)(B)(iii) of the Federal Food, Drug and Cosmetic Act has expired. The 180-day generic drug exclusivity awarded to Barr Laboratories has also expired.