Depomed Receives Certification Notice (NASDAQ:DEPO)
Source: http://www.favstocks.com/depomed-receives-certification-notice-nasdaq-depo/111916/Posted on Wednesday, November 11th, 2009 | In Biotech, Investing Lessons, Stocks to Watch
Depomed, Inc (NASDAQ:DEPO) announced that they have received a Paragraph IV certification notice from Lupin Limited advising Depomed of the filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration for a generic version of GLUMETZA (metformin hydrochloride extended release tablet) of 500 mg and 1000 mg strengths. Currently Depomed is evaluating the Paragraph IV certification notice and continues to have full confidence in the intellectual property protecting GLUMETZA. The Company is a specialty pharmaceutical company that formulates its products and product candidates with its approved Acuform drug delivery technology which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract.
At the moment, Depomed already has 2 product candidates in Phase 3 clinical development and two products already approved on the market while there are still many products in early stages which are in the pipeline. Lupin’s certification notice alleges that Depomed’s US Patents (Nos. 6,340,475; 6,488,962; 6,635,280; and 6,723,340) listed in the FDA Orange Book for GLUMETZA are invalid and/or will not be infringed by Lupin’s commercial manufacture, use or sale of the products described in Lupin’s ANDA.
Depomed now has 45 days from the receipt of the Paragraph IV certification to commence a patent infringement lawsuit against Lupin that would automatically stay, or bar, the FDA from approving Lupin’s ANDA for 30 months or until a district court decision that is adverse to the company, whichever is earlier.
Last 5 posts by Jay Garcilazo
- FDA Response to CPI-300’s NDA Anticipated Soon (NASDAQ:IGXT) - February 4th, 2010
- FDA Response to ODFS’s NDA Anticipated (NYSE:PRX) - February 4th, 2010
- FDA response on Autologel Sytem Expected Soon (AMEX:GTF) - February 4th, 2010
- FDA response on IL 13-PE expected on February 4, 2010 (NASDAQ:NEOL) - February 4th, 2010
- FDA Response Expected Expected Soon for Bovie (AMEX:BVX) - February 4th, 2010
 About Jay Garcilazo (http://favstocks.com)
I grew up in Boca Raton, Florida. After graduating high school I enrolled at Florida State University where I studied Journalism and Political Science. It was around this time that I got a job in the healthcare industry, a job that would give me a lot of experience as I worked and moved up over the next four and a half years. This along with working for a hedge fund manager for years, were the greatest learning experiences of my life so far. I have also been fortunate enough to have lived all over the country in, Austin, Texas, Queens, New York, Great Falls, Montana, Cleveland, Ohio, Chattanooga, Tennessee, Atlanta, Georgia, and all over the state of Florida. As well as living in many places I have traveled all over, been to all of the states except California (Had a layover at LAX once but I don’t think that counts), Oregon, and Hawaii. Traveled most of the Caribbean, I have also been to many destinations in Canada, and Mexico. I even did a stint through Europe. As well as traveling and living all over I have also worked in a great many industries. I have been employed in finance, healthcare, title, mortgage, travel, video game development, hospitality, and news industries. Besides working for an investment company I have also done quite a bit of investing on my own, and through trial and error, learning from mistakes, and watching the news very closely I have made some decent money for myself. |
No recommendations, either expressed or implied, are being made to buy, sell, hold or short any of the mentioned stocks. No legal, tax or accounting advice is expressed or implied. Always contact your attorney, CPA, or tax advisor before acting on any legal or tax issues. StraightStocks.com is not responsible for the content, products, or services of any of the advertisers on this site. StraightStocks.com receives compensation from advertisers on this blog. Services and products referred to herein are trademarks, registered trademarks, servicemarks, and/or registered servicemarks of their respective trademark or servicemark owners.