Alembic Pharma gets USFDA nod for generic constipation drug

Alembic Pharma gets U.S. FDA nod for generic chronic constipation drug

Alembic Pharmaceuticals has received final USFDA approval for its generic Prucalopride Tablets, used to treat chronic idiopathic constipation in adults. The drug is therapeutically equivalent to Takeda's Motegrity. Based on IQVIA data,…

The Story in Brief

Alembic Pharmaceuticals has received final USFDA approval for its generic Prucalopride Tablets, used to treat chronic idiopathic constipation in adults. The drug is therapeutically equivalent to Takeda's Motegrity. Based on IQVIA data, Alembic estimates the US market for the drug was $100 million in the year ending March 2026.

The Indian Opinion

There is a predictable cheer about USFDA approvals as a sign of Indian pharma's prowess. While the approval is a positive step, the $100 million US market estimate is a target, not a guaranteed revenue. Alembic will compete with other generic filers and the brand itself. Watch for how many competitors receive approval in the next quarter, that will determine if this is a blockbuster or just another filing.


Source: thehindu.com

This story was synthesised by AI from the source linked above.

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