Lupin gets FDA nod for generic equivalent of Doryx delayed-release tablets

Pharmaceutical giant, Lupin Limited, has achieved a significant milestone by obtaining the US Food and Drug Administration (FDA)’s green light for its Abbreviated New Drug Application (ANDA) of Doxycycline Hyclate Delayed-Release Tablets USP in multiple doses. This nod from the FDA paves the way for Lupin to introduce a generic counterpart of the popular Doryx and Doryx MPC Delayed-Release Tablets, originally manufactured by Mayne Pharma International Pty. Ltd.

Market Potential and Manufacturing:

The relevance of this approval is underscored by the substantial market footprint of Doxycycline Hyclate Delayed-Release Tablets USP. As per IQVIA MAT June 2023 data, the reference listed drug (RLD Doryx) reported impressive annual sales to the tune of USD 9 million in the U.S. market. Further sweetening the deal for Lupin is its in-house manufacturing capability, as the production of this drug is slated to occur at the company’s state-of-the-art Pithampur facility located in India.