United States Imposes New Section 232 Tariffs on Certain Patented Pharmaceuticals

New Section 232 tariffs on certain patented pharmaceuticals, active pharmaceutical ingredients (APIs), and key pharmaceutical starting materials are now taking effect following Presidential Proclamation 11020.

The action follows a Department of Commerce determination that U.S. dependence on foreign pharmaceutical production presents a national security concern and increases the risk of supply chain disruptions.

Products Covered

The proclamation applies to certain:

  • Patented pharmaceutical products

  • Active pharmaceutical ingredients (APIs)

  • Key pharmaceutical starting materials

Depending on eligibility, covered imports may be subject to combined tariff rates of up to 100%.

Tariff Structure

The proclamation establishes a framework that allows reduced tariff rates for certain qualifying imports, including those involving:

  • Eligible countries

  • Approved manufacturers

  • U.S. pharmaceutical manufacturing onshoring plans

  • Qualifying pharmaceutical pricing agreements

Manufacturers that do not meet approved onshoring or pricing commitments may lose preferential tariff treatment.

Products Generally Excluded

The proclamation generally excludes or provides zero-percent treatment for:

  • Generic pharmaceuticals

  • Biosimilars

  • Certain specialty pharmaceutical products

Importers should review the specific provisions of the proclamation to determine whether an exclusion or reduced rate applies.

Effective Dates

Implementation occurs in phases:

  • July 31, 2026 – Tariffs begin for certain listed companies.

  • September 29, 2026 – Broader implementation begins for additional covered imports.

What Importers Should Do

Companies importing pharmaceutical products should:

  • Review product classifications.

  • Confirm country of origin.

  • Determine whether products are patented and within the scope of the proclamation.

  • Verify manufacturer eligibility for any reduced tariff treatment.

  • Review applicable Chapter 99 reporting requirements.

  • Evaluate sourcing strategies and landed costs for future imports.

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