Lupin Launches Prucalopride Tablets in the U.S. Following FDA Approval

Lupin Limited, a global pharmaceutical major, announced the launch of Prucalopride Tablets (1 mg and 2 mg) in the United States on June 26, 2025. This follows the recent U.S. FDA approval of its Abbreviated New Drug Application (ANDA) for the product. The tablets are the generic equivalent of Motegrity® by Takeda Pharmaceuticals U.S.A. Inc., and are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. According to IQVIA MAT April 2025 data, Prucalopride Tablets (1 mg and 2 mg) had estimated annual U.S. sales of USD 184 million, indicating strong market potential. Headquartered in Mumbai, Lupin distributes its products in over 100 markets and holds a leadership position in India and the U.S. across several therapy areas including gastrointestinal, cardiovascular, and women’s health. With 15 manufacturing facilities and 7 research centers globally, Lupin continues to strengthen its presence in the U.S. generics market. This launch underscores Lupin’s strategic focus on expanding its complex generics portfolio and delivering accessible treatments to patients worldwide.