Geneva Continues Generic Ranitidine Battle

Geneva Pharmaceuticals, Swiss firm Novartis' generics unit in the USA,has filed an appeal against the decision which gave no generic company an exclusive marketing window, but which allowed Novopharm to commence marketing generic ranitidine (Marketletters passim), which resulted in a stay being issued by the Fourth Circuit Court of Appeals on July 9, the day before Novopharm was due to commence marketing, under the terms of an agreement with Glaxo Wellcome, whose patent on ranitidine, marketed as Zantac, expires on July 25.

Geneva said that the Fourth Circuit Court of Appeals in Richmond will hear the case and render a decision on exclusivity shortly after it reconvenes on September 29, and suggests that the US Food and Drug Administration could decide to allow eligible companies, including Geneva, to come to market at patent expiration on July 25.

Geneva believes it is eligible for an exclusive window because it was the first in line with an Abbreviated New Drug Application containing a "paragraph IV" certification. A "paragraph IV" certification challenges the patent or claims that the generic company's product does not infringe the innovator's product.