Mylan NV announced the US launch of doxycycline hyclate delayed-release (DR) tablets USP, 200 mg, a generic version of Mayne's Doryx. Mylan received final approval from the US Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) and was awarded 180 days of marketing exclusivity for this product. Doxycycline hyclate DR tablets are a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne.
Doxycycline hyclate DR tablets USP, 200 mg, had US sales of approximately $181.8 million for the 12 months ending March 31, 2016, according to IMS Health.
Currently, Mylan has 258 ANDAs pending FDA approval representing $109 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $37.4 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.