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News Breaks
January 28, 2013
16:25 EDTSNTS, MYLSantarus discloses lawsuit against Mylan for patent infringement
Santarus disclosed in a regulatory filing that on January 28, Santarus (SNTS) filed a lawsuit in the U.S. District Court for the District of Delaware against Mylan (MYL) and Mylan Pharmaceuticals for infringement of the patents listed in the Orange Book for Santarusí prescription product, Fenoglide tablets, 40 mg and 120 mg. Veloxis Pharmaceuticals A/S, licensor of the patents, is joined in the litigation as a co-plaintiff. The lawsuit is in response to an Abbreviated New Drug Application filed by Mylan with the U.S. FDA regarding Mylanís intent to market generic versions of Fenoglide prior to the 2024 expiration of the two listed patents. The lawsuit was commenced within the 45 days required to automatically stay, or bar, the FDA from approving Mylanís ANDA for 30 months or until a district court decision that is adverse to the plaintiffs, whichever may occur earlier.
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August 28, 2014
11:22 EDTMYLMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
August 22, 2014
08:02 EDTMYLMylan launches first generic Klor-Con Extended-release tablets
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August 20, 2014
11:44 EDTMYLMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
11:33 EDTMYLMylan into second round of bidding for GSK drug portfolio, WSJ reports
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August 19, 2014
11:44 EDTMYLMylan launches generic Precedex Injection
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August 18, 2014
10:06 EDTMYLLannett surges after upbeat Q4, FY14 outlook
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