Mylan N.V. (NASDAQ, TASE: MYL) disclosed the unveiling of Doxycycline Hyclate Delayed-Release (DR) Tablets USP, 50 mg, a generic version of Mayne's Doxteric, which is being marketed as Doryx in the United States. According to the company, it received final approval from the Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) and was awarded 180 days of marketing exclusivity for this product.
Mylan said it recently launched the 200 mg strength of this product with 180 days of exclusivity. Doxycycline Hyclate DR Tablets were a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne.
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The company said Doxycycline Hyclate DR Tablets, 50 mg, had U.S. sales of about $21.8 million for the 12 months ending March 31, 2016, according to IMS Health.
Currently, it has 254 ANDAs pending FDA approval representing $108.3 billion in annual brand sales, according to IMS Health. The company said that forty-three of these pending ANDAs were potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015. The figures were based on IMS Health.
The stock traded 2.81 percent higher on Wednesday.
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