New Delhi--In a significant development over the patent issue, Ranbaxy has challenged AstraZanca Eyeing a substantial pie from the lucrative market of the ulcer treatment drug Nexium in the US, India's pharma major Ranbaxy Laboratories has filed a para IV Abbreviated New Drug Application (ANDA) to the US Food and Drugs Administration chal lenging the patent of UK-based AstraZeneca.
When contacted Ranbaxy officials were non-committal and declined to comment on the patent challenge to AstraZeneca's block-buster drug Nexium.
In a statement on its Web site the UK-based firm said it had received a notice from the company about the submission of an ANDA for esomeprazole magnesium delayed-release capsules, 20mg and 40mg, containing Paragraph IV certifications of invalidity and/o r non-infringement with respect to certain AstraZeneca US patents.
AstraZeneca is evaluating Ranbaxy's notice and continues to have full confidence in its intellectual property protecting Nexium, the statement said.
The UK based pharma major said it had 45 days within which to commence a patent infringement lawsuit against Ranbaxy that would automatically stay, or bar, the FDA from approving Ranbaxy's ANDA for 30 months or until an adverse court decision, whichever may occur earlier.
Ranbaxy is the second Indian company after Dr Reddy's Laboratories to challenge AstraZeneca's Nexium patent