Sandoz Files U.S. Generic Tirzepatide Bids as Lilly Raises Canada Prices

The U.S. Food and Drug Administration has agreed to review two applications from Swiss manufacturer Sandoz for generic tirzepatide versions of Eli Lilly's Mounjaro and Zepbound, even as Lilly has raised Canadian list prices for the same brand under pressure from the Trump administration.

Sandoz enters the U.S. tirzepatide queue

The FDA has not specified how long its review will take, but the agency states it typically completes standard drug application reviews within 10 months. Sandoz has requested authorization for the same uses currently covered by Mounjaro and Zepbound, both of which contain the active ingredient tirzepatide.

The Sandoz generic candidates would be administered as a weekly injection, matching the Lilly reference products. Sandoz has estimated its product would cost between $200 and $400 per month in the U.S. without insurance, compared with brand-name pricing that can exceed $1,000 per month uninsured.

Claire D'Abreu-Hayling, president of Generics Development and chief scientific officer at Sandoz, said in a press statement that the submission "represents a key first step in our efforts to bring this medicine to market".

U.S. patents run to 2036 -- but Canada is a different market

Eli Lilly holds U.S. patent protection for Mounjaro and Zepbound until 2036, meaning generic tirzepatide cannot be marketed in the United States before then absent special FDA or court permission. Lilly's patents are expiring in other countries on different timelines.

Canada already saw its first generic semaglutide activity in 2026, and the queue of applicants for semaglutide before Health Canada is tracked on our generic semaglutide tracker. Tirzepatide, however, remains a Lilly-only molecule in Canada under the Mounjaro and Zepbound brands.

Lilly raises Canadian Mounjaro prices under Trump pressure

Eli Lilly has increased prices of Mounjaro in Canada as it responds to Trump administration pressure to lower U.S. prices and raise them elsewhere, and has also sharply raised prices in Britain. Reuters reported the U.K. list price for Mounjaro is being raised by 170 per cent.

Lilly introduced Mounjaro in Canada in late 2023, originally sold in single-dose weekly vials at a wholesale price of around $80 across six dosages. The company introduced the four-dose KwikPen format in January 2025, followed by a Zepbound KwikPen in June, and simultaneously raised vial prices to match the KwikPen while lowering vial production.

Cubic Health, which analyzes drug prices for insurance-plan sponsors, reported that the wholesale price for the KwikPen now ranges from $387 to $773 depending on dosage, which can produce an annual cost above $10,000. Current retail pharmacy prices tracked on GLP1Prices.ca for Mounjaro range from $271.62 to $800 CAD, which brackets the Cubic wholesale figures.

Lilly spokesman Ethan Pigott said in a statement that "Vials were only intended as a short-term solution until a multidose pen became available to the Canadian market" and that "the KwikPen device will be prioritized go-forward for its supply sustainability, ease of use and multidose presentation".

Canada Drug Agency status

Lilly had started an application to Canada's Drug Agency to have Mounjaro (tirzepatide) assessed in 2022, but a CDA spokesperson said the submission was cancelled because of paperwork deficiencies. Pigott said Lilly is finalizing plans to resubmit Mounjaro, along with Zepbound, to the CDA "in 2025".

Mounjaro and Zepbound are covered by some private insurance plans depending on individual plan designs, but are not yet covered by any public insurance plans, which require assessment through national bodies. Readers can check plan status via our insurance coverage checker or our FAQ. Novo Nordisk's Ozempic earned $2.5 billion at retail pharmacies in Canada in 2024, according to IQVIA data cited by the Globe and Mail -- nearly triple the next best-selling drug.

This article is for informational purposes only and does not constitute medical advice.

Sources

• Mounjaro, Zepbound: Generic GLP-1 Drugs May Soon Be ...
• Eli Lilly hikes price of Mounjaro weight-loss drug in ...