Lupin Receives Tentative Approval from U.S. FDA for Revefenacin Inhalation Solution.
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Lupin has received tentative approval from the U.S. FDA for its generic Revefenacin Inhalation Solution (175 mcg/3 mL), used for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). The drug is bioequivalent to Viatris' Yupelri® Inhalation Solution. The U.S. market for this product is estimated at USD 260.7 million annually (IQVIA data as of March 2026). This is a tentative approval under the Abbreviated New Drug Application (ANDA) pathway, meaning final approval may follow pending resolution of any remaining regulatory requirements. Lupin is a global pharmaceutical company headquartered in Mumbai with operations across 100+ markets.
Positive development for Lupin's U.S. portfolio expansion. Tentative approval opens the door to launching a generic COPD treatment in a USD 260+ million market, potentially boosting future revenue once final approval is granted. However, tentative status means commercial launch timing remains uncertain.