Friday 18 April, 2008

Teva got Tentative approval for Raloxifene tablets

Teva Pharma announced today that the USFDA has granted tentative approval to the Company's ANDA to market its generic version of Lilly's osteoporosis treatment Evista(R) (Raloxifene Hydrochloride) Tablets, 60 mg.
Raloxifene ([6-hydroxy-2-(4-hydroxyphenyl)- benzothiophen-3-yl]- [4-[2-(1-piperidyl)ethoxy]phenyl] –methanone) is an oral selective estrogen receptor modulator (SERM) that has oestrogenic actions on bone and anti-oestrogenic actions on the uterus and breast. It is used in the prevention of osteoporosis in postmenopausal women. On September 14, 2007, the USFDA announced approval of Raloxifene for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer
The brand product had annual sales of approximately $691 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data. Teva and Barr are involved in patent litigation concerning this product with ELI LILLY in the Indiana Southern District Court on following Orange book listed patents
US6458811 (Expiry 2017)
US5478847 (Expiry 2014)
US5457117 (Expiry 2012)
US5393763 (Expiry 2012)
US5641790 (Expiry 2014)
US5747510 (Expiry 2014)
US5731342 (Expiry 2017)
US6,797,719 (Expiry 2017)
US6894064 (Expiry 2017)
US6906086 (Expiry 2012)
USRE38968 (Expiry 2012)
USRE39049(Expiry2012) USRE39050 (Expiry 2014)

web page statistics
Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
eXTReMe Tracker