Wednesday, 23 July 2008

Lamotrigine Tablets: Teva (First generic player) launched tablets in US market

Teva Pharma has launched Lamotrigine Tablets in the US market. This product is AB rated and bioequivalent to Lamictal® Tablets. Lamotrigine Tablets are available in 25 mg and 100 mg strengths, in bottle sizes of 100, and in 150 mg and 200 mg strengths, in bottle sizes of 60.
This product has one orange book listed patent US4602017 which will expire on JAN 22,2009.On February 17, 2005, Teva issued a press release regarding settlement with innovator GSK. As per settlement Teva was granted the exclusive right to manufacture and sell its own generic version of Lamotrigine tablets (25mg, 100 mg, 150 mg, and 200 mg) in the United States during pediatric exclusivity of this product from July, 2008. Following firms have received tentative approval and will launch their product from January 23, 2009 onwards, when the pediatric exclusivity of this product will expire.
1) GENPHARM
2) DR REDDYS LABS LTD
3) ROXANE
4) MYLAN PHARMA
5) ZYDUS PHARMS USA INC
6) CARACO
7) WATSON LABS
8) SANDOZ
9) MATRIX LABS
10) TARO

According to industry sources, Lamictal(R) Tablets had annual U.S. sales of approximately $2.6 billion.

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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)
 
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