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

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million

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

Aurobindo Pharma wins USFDA approval for generic Xigduo XR

Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually

Marksans Pharma receives USFDA approval for Benzonatate capsules

Benzonatate is a non-narcotic antitussive that numbs stretch receptors in the respiratory tract

Lupin receives FDA’s tentative approval for Sugammadex injection

Sugammadex injection is bioequivalent to Merck’s Bridion injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery

Glenmark Therapeutics USA launches fluticasone propionate nasal spray

The Flonase Allergy Relief Nasal Spray, 50 mcg per spray market achieved annual sales of approximately $384.7 million

Glenmark Pharmaceuticals USA to launch Potassium Phosphates Injection USP in multiple vial sizes

The product is bioequivalent and therapeutically equivalent to Fresenius Kabi’s reference drug (NDA 212832)

Glenmark bags FDA nod for generic asthma inhaler with 180-day exclusivity