Latest news with #Motegrity
Business Standard
a day ago
- Business
- Business Standard
Zydus Lifesciences gets USDFA approval for Prucalopride tablets
Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for Prucalopride tablets, 1 mg and 2 mg. The said drug is equivalent to listed drug Motegrity tablets, 1 mg and 2 mg. Prucalopride is prescribed for chronic idiopathic constipation (CIC), a condition where the cause of constipation is unknown. It helps stimulate peristalsis, natural muscle contractions in the colon, to promote more regular bowel movements. The said tablets will be produced at the companys (SEZ), Ahmedabad. Prucalopride tablets had annual sales of $186.8 million in the United States (IQVIA MAT June 2025). As on 31st July 2025, the group has 422 approvals and has so far filed 483 ANDA since the commencement of the filing process in FY 2003-04. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The companys consolidated net profit shed 1% to Rs 1,170.90 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24. The counter fell 1.04% to end at Rs 935.50 on Friday, 8 August 2025.
Time of India
26-06-2025
- Business
- Time of India
Lupin launches generic chronic constipation treatment drug in US
Pharma major Lupin Ltd on Thursday said it has launched its generic version of Prucalopride tablets used to treat chronic idiopathic constipation in the US market after the recent approval by the country's health regulatory. The Mumbai-based company has launched Prucalopride tablets of strengths 1 mg, and 2 mg in the US, following the recent approval of its abbreviated new drug application (ANDA) from the USFDA, Lupin said in a regulatory filing. These Prucalopride tablets are bioequivalent to Motegrity tablets , 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc and are indicated for the treatment of chronic idiopathic constipation (CIC) in adults, it added. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Play War Thunder now for free War Thunder Play Now Undo Citing IQVIA MAT April 2025 data, the company said Prucalopride tablets, 1 mg and 2 mg, had estimated annual sales of USD 184 million in the US.
Business Standard
26-06-2025
- Business
- Business Standard
Lupin launches Prucalopride Tablets in US market
Lupinannounced the launch of Prucalopride Tablets, 1 mg, and 2 mg, in the United States, following the recent approval of its Abbreviated New Drug Application (ANDA) from the U.S. FDA. Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc., and indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride Tablets, 1 mg, and 2 mg (RLD Motegrity) had estimated annual sales of USD 184 million in the U.S. (IQVIA MAT April 2025).
The Hindu
25-06-2025
- Business
- 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
25-06-2025
- Business
- 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.
