April 15, 2008--AstraZeneca today announced it has entered into a settlement agreement in its Nexium patent infringement litigation against Ranbaxy Laboratories Ltd. and its affiliates (“Ranbaxy”).
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy’s submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product.
The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014. This date marks the expiry of US Patent Numbers 5,877,192 and 6,875,872. AstraZeneca’s patents protecting Nexium have expiration dates that range from 2014 through 2019.
AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.
Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck's restructured partnership with AstraZeneca announced in 1998, has also entered into the settlement agreement.
AstraZeneca’s Nexium patent infringement litigations against Teva/IVAX and Dr Reddy’s Laboratories remain ongoing.
“I believe that this agreement is the right business decision and gives increased clarity and stability to allow us to continue investing substantially in our growing pipeline of new medicines for patients. We continue to have confidence in the strength of our patents and will vigorously defend our intellectual property,” said David Brennan, Chief Executive Officer of AstraZeneca.
1 comment:
My name is Jon Star and i would like to show you my personal experience with Nexium.
I am 34 years old. Great medicine. I only hope that I don't become dependant on it. But as my esphogus heals then maybe I'll be able to take an OTC PPI if my symtoms re-occur and I catch them ASAP! Can't wait for a generic. BLUE CROSS of MA won't pay for Nexium unless I start on generic Prilosec, then Protonix, then if both of those failed, they would pay for Nexium. I hate BLUE CROSS! My Dr. was great in giving me 7 weeks of samples when he heard this and Aztra-Zeneca gave me a 7-day coupon I re-deemed at my local pharmacy(with a written 7-day script from my Dr.)
No major side effect. Sometimes a feeling of indigestion/bloated, possibly due to low or no stomach acid as a result of a PPI. So, I am sure to chew my food well and not to eat large portions. I have introduced foods/drinks back into my diet, that before taking Nexium would otherwise bring-on reflux symtoms. Fruit juices and citric acid containing drinks still are bothersome. But, I've eaten Pizza, and am able to drink coffee/tea, both decaf(not to excess though.) A little at a time. I do not drink any alcohol! I still limit any food intake 3 hours before bedtime and try to sleep on my left side. Nexium has given me the greatest relief as compared to all OTC H2 and OTC PPI's. I'm on week 5 of an 8 week treatment.
I hope this information will be useful to others,
Jon Star
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