BY OUR PHARMA CORRESPONDENT
July 30, 2005: United State Food and Drugs Administration has granted final approval for Barr Laboratories’ANDA for 60 mg fexofenadine hydrochloride capsules.
The product is a generic equivalent of Sanofi-Aventis’ Allegra, used 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 aged six years and above.
According to IMS data, sales of 60 mg Allegra capsules in the year ended May 2005 were worth around US$14,000. The product is no longer marketed by Sanofi-Aventis.
Barr was the first company to file an ANDA with a Paragraph IV certification for the product, and so was entitled to the 180-days marketing exclusivity. Barr filed its ANDA in May 2001, and in response, Aventis filed a patent infringement lawsuit in the US District Court for the District of New Jersey. Allegra is covered by a number of
patents listed in the FDA's Orange Book, and the last of these expires in 2017.
However, in July 2004, Barr announced that the New Jersey Court had granted summary judgement of non-infringement with respect to three patents in the litigation between the two. On 1st April 2005, Barr further announced that the Court had granted summary judgement of invalidity on an additional patent in the case.
The Court has yet to rule on five patents relating to both the tablet and capsule forms of Allegra. Three of these are method-of-use patents, and the other two are raw materials patents. Although no trial date has yet been set, it anticipates that the case will be ready for trial in 2006.
Separately, Teva Pharmaceutical Industries has announced the FDA has granted it tentative approval for its ANDA for 30 mg, 60 mg and 180 mg fexofenadine hydrochloride tablets. Teva is also currently in litigation with Sanofi-Aventis over its version of the product in the US District Court for the District of New Jersey.