Lupin gets U.S. FDA nod for generic of Takeda's constipation drug
Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for Prucalopride Tablets 1 mg and 2 mg that are indicated for treatment of chronic idiopathic constipation (CIC) in adults.
Prucalopride Tablets are bioequivalent to Motegrity Tablets 1 mg and 2 mg of Takeda Pharmaceuticals U.S.A. Inc, Lupin said on U.S. FDA approving its abbreviated new drug application.
Lupin will manufacture the product at its Goa facility. Prucalopride Tablets 1 mg and 2 mg (reference listed drug Motegrity) had estimated annual sales of $184 million in the U.S, the company said citing IQVIA MAT April 2025 numbers.
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The Hindu
6 hours ago
- The Hindu
Lupin gets U.S. FDA nod for generic of Takeda's constipation drug
Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for Prucalopride Tablets 1 mg and 2 mg that are indicated for treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride Tablets are bioequivalent to Motegrity Tablets 1 mg and 2 mg of Takeda Pharmaceuticals U.S.A. Inc, Lupin said on U.S. FDA approving its abbreviated new drug application. Lupin will manufacture the product at its Goa facility. Prucalopride Tablets 1 mg and 2 mg (reference listed drug Motegrity) had estimated annual sales of $184 million in the U.S, the company said citing IQVIA MAT April 2025 numbers.
Business Standard
13 hours ago
- Business Standard
Lupin receives USFDA approval for generic Prucalopride tablets
Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Prucalopride tablets. The tablets are a generic equivalent of Motegrity Tablets, developed by Takeda Pharmaceuticals U.S.A., Inc., and are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Lupin stated that the approved product is bioequivalent to Motegrity and will be manufactured at the companys facility in Goa, India. According to IQVIA MAT data for April 2025, Prucalopride Tablets (Reference Listed Drug: Motegrity) had estimated annual sales of approximately $184 million in the United States. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24. The scrip rose 0.07% to Rs 1,932.10 on the BSE.
Time of India
14 hours ago
- Time of India
Lupin gets USFDA nod for generic chronic constipation treatment drug
Synopsis Lupin Limited has received the United States Food and Drug Administration approval for its generic version of Prucalopride tablets. These tablets are used for treating chronic idiopathic constipation. The approved strengths are 1 mg and 2 mg. This generic medicine is bioequivalent to Takeda Pharmaceuticals' Motegrity tablets. Lupin will manufacture the product at its Goa facility in India.
