Published on July 23, 2004 at 9:03 AM
AstraZeneca has confirmed that it has filed a lawsuit in the U.S. District Court for the District of Delaware against the generic company Andrx for patent infringement.
The lawsuit is the result of a Paragraph IV Certification letter submitted by Andrx to AstraZeneca concerning its intent to manufacture and sell metoprolol succinate in the 25 mg dose form in the United States. Metoprolol succinate is marketed as TOPROL-XL(R) in the U.S. by AstraZeneca, LP. The basis for AstraZeneca's complaint is that the action taken by Andrx infringes AstraZeneca's patents covering TOPROL-XL.
In February of this year, AstraZeneca filed suit against Andrx for patent infringement for the 50 mg dose form of TOPROL-XL. Additionally, AstraZeneca filed suit in May of 2003 against KV Pharmaceuticals for patent infringement for the 200 mg dose form and again in August of 2003 for patent infringement for the 100 mg dose form. In 2003, TOPROL-XL had U.S. sales of $909m. Of these sales, approximately 15% were in the 25 mg dosage.
http://www.astrazeneca-us.com/