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news.BTG International, Janssen Biotech, Janssen Oncology and Janssen Research & Development have sued Mylan as regards filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Abiraterone Acetate Tablets, 250mg.
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The lawsuit has been filed in the United States District Court for the District of New Jersey.
Mylan claims to be one of the first to have filed an ANDA containing a Paragraph IV certification for the product stated to be the generic version of Zytiga. The firm also expects to be eligible for 180 days of marketing exclusivity after obtaining a final go-ahead from FDA.
The product is indicated in combination with prednisone for treating patients with metastatic castration-resistant prostate cancer.
Zytiga had registered sales worth around $1.08bn in the US during the year ending June, according to IMS Health.
At present, Mylan reportedly has 268 ANDAs awaiting nod from FDA representing $101.3bn in annual brand sales. Of them, 50 have been stated to be potential first-to-file opportunities, representing $33.4bn in annual brand sales for one year ending December, 2014.
Mylan, a global pharmaceutical company, has around 1,400 generic pharmaceuticals and several brand medications under its product lineup.