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Pharma & Biotech

FDA ends tirzepatide shortage, impacting copycat manufacturers

The US Food and Drug Administration (FDA) has declared an end to the shortage of Eli Lilly's GLP-1 drug tirzepatide, used in the weight-loss drug Zepbound and diabetes medication Mounjaro.

This decision, following a lawsuit by compounding pharmacies, begins a 60-day countdown for manufacturers of unapproved versions to cease production.

Eli Lilly attributed the resolution to expanded manufacturing capacity, warning against marketing unapproved tirzepatide knockoffs.

Rival Novo Nordisk (NYSE:NVO)'s GLP-1 drugs, Ozempic and Wegovy, are also expected to leave the FDA's shortage list soon.

The ruling has disrupted compounding pharmacies and platforms like Hims & Hers, with Allurion's stock dropping 13% on the news.

Compounding trade groups argue shortages persist, citing patient difficulties accessing branded drugs. Meanwhile, telehealth companies plan collaborations with pharmaceutical firms to offer branded medications at reduced prices.