Peptide News Digest

#Apotex

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Regulatory · View digest

President Trump Announces Tuesday July 21 That Imported Generic Drugs Will Face Zero Tariffs for Two Years Starting August 1, 2026 Before a 100% Levy Takes Effect in August 2028 and Rises to 200% One Year Later — The Phased Schedule Is Designed to Push Generic Drugmakers to Onshore US Manufacturing; The Policy Directly Affects the Sandoz Generic Tirzepatide ANDAs Accepted by the FDA on June 29 and the Indian Generic Semaglutide Launches That Biocon, Dr. Reddy's, and Hetero Rolled Out in March-April 2026

President Donald Trump announced Tuesday July 21, 2026 via social media that imported generic drugs will face zero tariffs for two years starting August 1, 2026 before a 100% levy takes effect in August 2028 and rises to 200% one year later. Trump described the escalation as 'a penalty' for companies that do not build manufacturing plants in the US within the grace period. India is the largest exporter of generic medicines to the US ($10.5 billion in fiscal year 2024-25), with pharmaceuticals among India's top three exports to America. Companies with the greatest exposure include Teva, Viatris, and Apotex, all of which manufacture a large share of US-sold products overseas. Sandoz (Novartis' generic subsidiary), which had two Abbreviated New Drug Applications for generic tirzepatide (Mounjaro and Zepbound) accepted by the FDA on June 29, 2026, told CNBC it was 'too early to assess' the proposal because 'further details on the implementation and scope of the measure are still required.' The tariff timeline collides with the tirzepatide patent expiration (2036 in the US) and the Indian generic semaglutide launches from Biocon, Dr. Reddy's, and Hetero that rolled out in March-April 2026. Patented and branded drugs remain unchanged under the April 2 Section 232 100% patented pharma tariff.

Regulatory · View digest

Health Canada Approves Second Generic Semaglutide (Apotex) on May 1 — Canada Becomes First G7 Country With Two Approved Ozempic Generics

Health Canada announced May 1 approval of a second generic semaglutide injection, filed by Canadian-based Apotex as a generic version of Novo Nordisk's Ozempic. The April 28, 2026 first approval (Dr. Reddy's Laboratories) was followed three days later by the Apotex green light, making Canada the first G7 country with two approved generic semaglutide products. Health Canada is currently reviewing seven additional generic submissions. Patent context: Canadian patent protection lapsed earlier than expected after a Novo Nordisk maintenance-fee issue. Sandoz separately targets a Q3 2026 commercial launch and the company has projected 45-90% price reductions versus brand-name Ozempic. US patent protection runs through December 2031.