Mylan received final approval from the U.S. 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 also recently announced the launch of the 200 mg strength of this product with 180 days of exclusivity. Doxycycline Hyclate DR Tablets are a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne.
Doxycycline Hyclate DR Tablets, 50 mg, had U.S. sales of approximately $21.8 million for the 12 months ending March 31, 2016, according to IMS Health.
Currently, Mylan has 254 ANDAs pending FDA approval representing $108.3 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.