Mylan Inc. this week launched a pair of new generic products and unveiled agreements with Warner Chilcott Co. and Prosonix that will lead to future generic offerings.

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Mylan announces new, upcoming generics

April 18th, 2014

PITTSBURGH – Mylan Inc. this week launched a pair of new generic products and unveiled agreements with Warner Chilcott Co. and Prosonix that will lead to future generic offerings.

Mylan said Wednesday that it has rolled out Xulane (norelgestromin/ethinyl estradiol 150/35 mcg per day), a contraceptive patch for women. The product is a generic version of Janssen Pharmaceuticals Inc.'s Ortho Evra transdermal system.

Ortho Evra had U.S. sales of about $152.9 million for the 12 months ended Dec. 30, according to IMS Health data cited by Mylan.

"Mylan is proud to continue expanding its portfolio of transdermal products through the launch of the first generic Ortho Evra Patch," Mylan chief executive officer Heather Bresch said in a statement. "Mylan's Xulane, which provides women with a high-quality, affordable treatment option, once again demonstrates Mylan's commitment to bring to market difficult-to-develop and -manufacture medicines in support of our mission to expand access to high-quality medicine."

On Tuesday, Mylan announced the launch of eszopiclone tablets (1 mg, 2 mg and 3 mg), a generic version of Sunovion Pharmaceuticals Inc.'s Lunesta, indicated for the treatment of insomnia.

Eszopiclone tablets in those dosages had U.S. sales of $851.8 million through the end of December, based on IMS Health figures.

Also on Tuesday, Mylan said that the company and its partner Famy Care Ltd. have entered into a patent settlement and license agreement with Warner Chilcott (now part of Actavis plc) on norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and ferrous fumarate chewable tablets, a generic version of Generess Fe Tablets, a contraceptive.

Under the agreement, Mylan can start selling a Generess Fe generic on April 1, 2015, or earlier under certain circumstances, and upon receiving final Food and Drug Administration approval. Alternatively, Mylan will be permitted to launch an authorized generic version of the product beginning on Oct. 1, 2015.

Mylan added that it believes Famy Care is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for norethindrone and ethinyl estradiol chewable tablets 0.8 mg/0.025 mg and ferrous fumarate chewable tablets.

Through Dec. 31, Generess Fe Tablets had U.S. sales of approximately $81.83 million, according to IMS Health.

Mylan, too, reported on Tuesday that it has entered into a global licensing agreement with specialty pharmaceutical company Prosonix for its inhaled respiratory products PSX1001 and PSX1050.

The first products to emerge from Prosonix's proprietary particle engineering platform, PSX1001 and PSX1050 are being developed as generic versions of GlaxoSmithKline's pressurized metered dose inhalers Flixotide and Flovent, respectively. Flixotide and Flovent contain the active ingredient fluticasone propionate, an inhaled corticosteroid for the treatment of asthma.

According to figures from IMS Health, Flixotide and Flovent had global brand sales of about $1.3 billion through Dec. 31. A first marketing authorization application for PSX1001 is expected to be submitted in the European Union in 2014.

"We are very excited to enter into this agreement with Prosonix, as it represents another development milestone in our global respiratory franchise, one of our key strategic growth drivers, and strengthens our portfolio of difficult-to-develop and -manufacture products," stated Rajiv Malik, president of Mylan. "Further, Prosonix's expertise in the development of inhaled respiratory products perfectly complements the strength of Mylan's respiratory R&D capabilities. We look forward to a successful collaboration with Prosonix in the coming years as we bring to market generic versions of Flixotide and Flovent around the world."

Under 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 United States, Canada, Australia, New Zealand, India, Japan, the EU, Iceland, Liechtenstein, Norway, Switzerland, Turkey, the Russian Federation and the Commonwealth of Independent States.