India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga

Lupin wins USFDA nod for generic Dapagliflozin tablets

Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market

Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity

Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size

Zydus gets USFDA final approval for generic Dapagliflozin with 180-day shared exclusivity

Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility

Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity

Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.

Zydus receives FDA’s tentative approval for Dapagliflozin Tablets

Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets

Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US

Lupin receives tentative approval from USFDA for Dapagliflozin Tablets

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US

Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Type 2 diabetes

Glenmark's Zita portfolio of medicines have been benefiting around 1.75 million Type 2 diabetic patients annually

AstraZeneca India receives permission from DCGI for Dapagliflozin

The approval allows treatment of heart failure patients irrespective of the ejection fraction based on new trial DELIVER conducted by AstraZeneca