USFDA Clears Alembic Pharma's Generic Constipation Treatment

Indian drugmaker Alembic Pharma has expanded its US portfolio with USFDA approval for generic constipation treatment.

The medicine is used to treat chronic idiopathic constipation in adults. The approval gives the company access to a market worth about USD 100 million.

The approval covers 1 mg and 2 mg strengths. The medicine treats chronic idiopathic constipation in adults. This approval gives the company access to a market worth nearly USD 100 million in the United States.

The approval came through the company's ANDA filed with the US regulator. The approved tablets are therapeutically equivalent to Takeda Pharmaceuticals USA's Motegrity tablets. This allows Alembic to market a lower-cost generic alternative in the US. The approval also strengthens the company's growing presence in the global generic medicines market.

Approval Opens a USD 100 Million Market

Prucalopride tablets are prescribed to treat adults with chronic idiopathic constipation. The condition causes long-term constipation without an identifiable medical cause. Patients often require prescription medicines when lifestyle changes fail to provide relief.

According to IQVIA data, the combined US market for the 1 mg and 2 mg tablets reached an estimated USD 100 million. The estimate covers the 12 months ended March 2026. The market size highlights the commercial opportunity for Alembic in the United States.

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Generic Drug Expands Alembic's US Portfolio

The approved medicine is equivalent to Takeda's branded Motegrity tablets. Such approvals help increase competition and improve patient access to affordable treatments. Generic medicines also reduce healthcare costs across major markets.

The latest approval adds another product to Alembic's expanding US portfolio. The company has continued to receive regulatory clearances for several generic medicines. These approvals support its long-term strategy of expanding in the world's largest pharmaceutical market.

Why This Approval Matters

The latest US regulatory clearance offers several benefits for Alembic:

• Expands its generic medicine portfolio in the US.
• Provides entry into a USD 100 million market.
• Strengthens its presence in gastrointestinal treatments.
• Increases opportunities for future revenue growth.
• Reinforces its focus on regulated international markets.

With another USFDA approval in hand, Alembic continues to build its position in the competitive US generics business. The latest launch could help the company strengthen its market share while offering patients a more affordable treatment option for chronic constipation.