Actavis enters into agreement with Mylan, Famy Care regarding generic Generess FE
DUBLIN — Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan’s generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).
Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess 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.
Mylan gains U.S., Canada rights to proposed generic equivalents of Flixotide and Flovent
OXFORD, England — Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines by Design, on Tuesday announced that it has entered into a global licensing agreement with Mylan for its leading inhaled respiratory products, PSX1001 and PSX1050.
PSX1001 and PSX1050, which are the first products to emerge from Prosonix’s proprietary particle engineering platform, are being developed as generic versions to GlaxoSmithKline’s pressurised metered dose inhalers Flixotide and Flovent, respectively. Flixotide and Flovent contain the active ingredient fluticasone propionate, a potent inhaled corticosteroid, and are indicated for the treatment of asthma.
According to IMS Health, Flixotide and Flovent had global brand sales of approximately $1.3 billion for the 12 months ended Dec. 31, 2013. A first marketing authorisation application for PSX1001 is expected to be submitted in the European Union in 2014.
Under the terms of the licensing agreement, Prosonix will file PSX1001 in the EU and retain marketing rights in certain territories. Mylan has marketing rights for PSX1001 and PSX1050 in the U.S., Canada, Australia, New Zealand, India, Japan, the EU, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Russian Federation and the Commonwealth of Independent States. All other terms of the agreement remain confidential.
Mylan announces launch of generic Lunesta
PITTSBURGH — Mylan announced that it has launched eszopiclone tablets in 1 mg, 2 mg and 3 mg form. The drug — which is used for the treatment of insomnia — is the generic version of Lunesta from Sunovion Pharmaceuticals.
Mylan received final approval from the Food and Drug Administration for its abbreviated new drug application. Eszopiclone tablets had sales in the U.S. of approximately $851.8 million for the 12 months ending Dec 31, 2013, according to IMS Health.