Opinion ID: 178456
Heading Depth: 2
Heading Rank: 3

Heading: Apotex's ANDA

Text: Apotex submitted an ANDA seeking FDA approval to manufacture and sell a generic version of budesonide for twice-daily use, a use not claimed in either the '603 or '099 patents. The ANDA included a proposed label for the generic drug that, with certain exceptions, is identical to the label included with AstraZeneca's budesonide product. Specifically, in its label, Apotex replaced the PULMICORT RESPULES® brand name on Astra-Zeneca's product with the generic name budesonide inhalation suspension. Apotex also submitted a section viii statement asserting that it was not seeking approval for the once-daily method of use claimed in the '603 and '099 patents and that its proposed generic label would contain no explicit mention of once-daily administration. However, the proposed label retained the FDA-mandated downward-titration language found in AstraZeneca's PULMICORT RESPULES® product label. Apotex further represented that the proposed label would indicate that the generic drug is available in only two strengths: 0.25 mg and 0.5 mg per 2 mL vial. The FDA approved Apotex's ANDA on March 30, 2009.