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News Breaks
January 28, 2013
16:25 EDTMYL, SNTSSantarus 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.
News For SNTS;MYL From The Last 14 Days
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April 23, 2014
06:53 EDTMYLFood & Drug Law Institute to hold a conference
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April 21, 2014
08:18 EDTMYLMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
April 19, 2014
18:50 EDTMYLMylan says Teva denied injunction seeking to prevent launch of generic Copaxone
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April 17, 2014
04:22 EDTMYLMylan (MYL) implied volatility of 45 at upper end of index mean range
April 16, 2014
16:16 EDTMYLMylan launches first generic Ortho Evra patch
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April 15, 2014
10:21 EDTMYLMylan announces settlement agreement for first-to-file Generess
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10:10 EDTMYLMylan launches generic Lunesta tablets
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08:07 EDTMYLActavis announces agreement related to Generess FE patent challenge litigation
Actavis (ACT) announced that it has entered into an agreement with Mylan (MYL) and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess. Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generessģ FE under its pending Abbreviated New Drug Application beginning on April 1, 2015. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015. Other terms of the settlement were not disclosed. Actavis remains in litigation with Lupin Ltd in connection with Lupin's pending ANDA for a generic version of Generess.
08:06 EDTMYLProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
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April 11, 2014
11:50 EDTMYLStocks with call strike movement; TNA MYL
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10:30 EDTMYLActavis and Mylan shares recommended at Bernstein
07:31 EDTMYLMylan confirms judge enforces agreement with Endo regarding generic Frova
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