Mylan Launches Generics for Viramune XR, Glucotrol XL, Axert  11/18/2015


Global Pharmaceutical company Mylan N.V., which has U.S. offices in Pittsburgh, has launched Nevirapine Extended-release Tablets, 100 mg -- the generic version of Boehringer Ingelheim's Viramune XR – in the United States today, one of four generic U.S. launches it has held this week.

Also launched this week were Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical's AXERT; and Glipizide Extended-release Tablets, 5 mg and 10 mg, the generic version of Pfizer's GLUCOTROL XL.


Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for each of these drugs.

Nevirapine
Nevirapine is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age. The launch adds to Mylan's growing portfolio of ARV medicines across the globe, and represents the company's continued commitment to stem the tide of HIV/AIDS. Approximately 50 percent of those being treated for HIV/AIDS in the developing world, for example, rely on a Mylan product, according to the company. Nevirapine Extended-release Tablets, 100 mg, had U.S. sales of approximately $67 thousand for the 12 months ending Sept. 30, 2015, according to IMS Health.

Almotriptan
Almotriptan is used for the acute treatment of migraine attacks in adult patients with a history of migraine with or without aura. In adolescents age 12 to 17 years, it is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated). Almotriptan Tablets USP, 6.25 mg and 12.5 mg, had U.S. sales of approximately $29.2 million for the 12 months ending Sept. 30, 2015, according to IMS Health.

Glipizide
Glipizide Extended-release Tablets, 5 mg and 10 mg, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide Extended-release Tablets, 5 mg, and 10 mg, had U.S. sales of approximately $70.7 million for the 12 months ending September 30, 2015, according to IMS Health.

Currently, Mylan has 253 ANDAs pending FDA approval representing $100.8 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $36.1 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.

Mylan is a global pharmaceutical company with a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, it offers a wide range of antiretroviral therapies, upon which nearly 50 percent of HIV/AIDS patients in developing countries depend. It also operates one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories.

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Joseph Tarnowski

VP Content
ECRM

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