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News Breaks
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November 10, 2009
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| 09:02 EDT |  | DEPO |
| theflyonthewall.com: | DepoMed receives Notice of Paragraph IV for Glumetza | | Depomed announced that it has received a Paragraph IV certification notice from Lupin Limited advising Depomed of the filing of an Abbreviated New Drug Application with the FDA for a generic version of Glumetza, 500 mg and 1000 mg strengths. Lupin’s certification notice alleges that Depomed’s U.S. Patents 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. U.S. Patent No. 6,340,475 will expire in 2016, U.S. Patent No. 6,488,962 will expire in 2020, U.S. Patent No. 6,635,280 will expire in 2016 and U.S. Patent No. 6,723,340 will expire in 2021. Depomed is evaluating the Paragraph IV certification and continues to have full confidence in the intellectual property protecting GLUMETZA. Depomed 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. :theflyonthewall.com |
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February 3, 2012
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| 16:18 EDT | | DEPO |
| theflyonthewall.com: | DepoMed receives $10M upon signing license agreement with Merck | | Depomed (DEPO) announced that Merck (MRK) disclosed that the FDA approved Janumet XR tablets, a new treatment for type 2 diabetes that combines sitagliptin. Depomed has provided Merck a license to certain of Depomed's patents directed to metformin extended release technology for Janumet XR pursuant to the terms of the license agreement signed with Merck in 2009. Depomed received $10M upon signing the license agreement and $2.5M upon Merck's filing of the Janumet XR New Drug Application with the FDA. Depomed will receive modest, single-digit royalties on net product sales of Janumet XR through the expiration date of the licensed patents. :theflyonthewall.com |
| | 09:29 EDT |  | DEPO |
| theflyonthewall.com: | DepoMed target raised to $10 from $8 at JMP Securities | | JMP Securities increased its target on Depomed (DEPO) after Merck (MRK) announced FDA approval of Janumet XR, which is based on Depomed's proprietary drug delivery technology. The firm notes that Depomed will receive a royalty from Merck, and it reiterates an Outperform rating, :theflyonthewall.com |
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