Barr Sues FDA to Obtain Sole Exclusivity on Allegra-D(R)
Barr filed an Abbreviated New Drug Application (ANDA) for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Tablets in September 2001. Barr's ANDA included a paragraph IV certification to patents listed in the Orange Book for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Tablets. Aventis filed suit against Barr in United States District Court for the District of New Jersey within the 45-day Hatch-Waxman period. In 2002, Aventis obtained and listed an additional patent in connection with Allegra-D(R). Barr believes that FDA will conclude that another company filed the first paragraph IV certification to that subsequently listed patent and, on that basis, attempt to force Barr to "share" its exclusivity with that other company.
"We believe that the exclusivity provisions of Hatch-Waxman are clear and that the first company to file a patent challenge is entitled to the 180-day incentive. We will seek all remedies to ensure that the incentive of 180 days of generic exclusivity is preserved as Congress intended," said Bruce L. Downey, Barr's Chairman and CEO.
Most read news
Other news from the department politics & laws
Get the chemical industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.