Mylan N.V. announced the U.S. launch of Doxycycline Hyclate Delayed-Release (DR) Tablets USP, 50 mg, a generic version of Mayne's Doxteric, which is being marketed as Doryx.
Mylan received final approval from the U.S. FDA for its supplemental Abbreviated New Drug Application (sANDA) and was awarded 180 days of marketing exclusivity for this product, according to a press release. 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. The product 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, says IMS Health.