By the PharmaTradz BD Team. Published October 2026.
The US tariff on patented medicines has now applied to every importer since 29 September. For the first two months only 17 large companies paid it; everyone else simply reported their entries. That grace period is over. If you buy or sell APIs, intermediates or finished medicines for the US market, three weeks of real entries have made a few things much clearer. This piece sets out what the rules cover, what they leave out, and the questions worth putting to your suppliers and customs broker now.
This is a plain-language summary for sourcing teams, not legal or customs advice. Rates and lists can change by notice, so always confirm a specific entry with a licensed customs broker.
What the tariff covers
The tariff comes from a Section 232 proclamation signed on 2 April 2026. It targets patented pharmaceutical articles: medicines listed in FDA's Orange Book or Purple Book that are still protected by a valid, unexpired US patent. Three kinds of goods are caught:
- the finished patented medicine itself;
- the API used to make it, whether or not the API has its own patent;
- the key starting materials used to make that API.
Inactive ingredients and excipients are outside the definition. So is anything of US origin.
The point that catches many API buyers out is that coverage follows the medicine, not the chemistry. An API that is off patent everywhere else can still be covered if it goes into a product that is patent-protected in the United States.
The rates in one table
The headline rate is 100%, but most of the real-world answers sit in the exceptions. Where more than one rate could apply, the lowest one is used.
| Situation | Rate | Worth knowing |
|---|---|---|
| Patented medicine, its API or key starting material, standard case | 100% (combined with normal duty) | Applies to all importers since 29 September 2026 |
| Made in the EU, Japan, South Korea, Switzerland or Liechtenstein | 15% (combined) | Follows commitments in existing trade deals |
| Made in the United Kingdom | 10% | Could fall further under a UK–US pricing deal |
| Company with an approved US onshoring plan | 20% | Rises to 100% on 2 April 2030 if the plan is not delivered |
| Onshoring plan plus a pricing agreement with the US government | 0% | Runs until 20 January 2029 |
| Generics, biosimilars and authorised generics, with their ingredients | 0% | Declared under its own heading at entry |
| Listed specialty products from listed countries | 0% | See the next section |
| Material used only for clinical trials, R&D or other non-commercial use | 0% | A new heading added in September |
Generics, biosimilars and specialty products are out, for now
Generic medicines are exempt. That covers products approved through an ANDA, certain 505(b)(2) products rated as therapeutically equivalent, biosimilars and authorised generics, together with their APIs. For most generic API and finished-dose trade into the US, nothing has changed on duty.
On 23 September, Commerce confirmed a 0% rate for a set of specialty categories, as long as they come from a listed country. The categories are:
- medicines whose approved uses are all orphan-designated;
- plasma-derived therapies;
- cell and gene therapies;
- antibody–drug conjugates;
- nuclear medicines;
- fertility drugs;
- medical countermeasures;
- animal health products.
The list of countries is broad. It includes the EU, the UK, Switzerland, Japan, South Korea, India, Taiwan and several Southeast Asian and Latin American countries. Commerce has said the list can change.
There are two things to watch. First, the generics exemption is not permanent. By April 2027, Commerce has to tell the President whether tariffs on generics may be warranted. Second, a product's status can change. When a patent expires or is struck down and generic versions launch, the reference product and its API can move from the covered list to the exempt one. That timing matters to anyone buying the API for a molecule that is about to lose exclusivity.
What this means for sourcing
Origin now carries a price. For a patented product, the gap between 100% and 15% is often bigger than any difference in unit cost between suppliers. Some brand owners are already looking again at where their API and starting materials are made. This is creating real demand for qualified second sources in the EU, Switzerland, Japan and Korea.
Generic supply is stable, but contracts need a clause. Generic APIs pay no new duty today. Even so, three- to five-year supply agreements signed now will run past the April 2027 review. A simple clause that says who bears any future tariff saves a difficult conversation later.
Specialty products need paperwork, not just a code. The 0% rate for plasma-derived products, ADCs and orphan drugs depends on the country of origin and on the product genuinely falling within the category. Keep the evidence ready, because customs can ask for it.
Development material has its own route. APIs and samples imported only for clinical trials or R&D can use the non-commercial 0% heading. Label and document these shipments clearly so they are not classed as commercial stock.
Questions to ask before your next US shipment
| Ask | Why it matters |
|---|---|
| Which US product will this API or starting material go into, and is that product patent-listed today? | Coverage follows the finished medicine, not the ingredient |
| Where is each step made: starting material, API and finished dose? | Origin decides between the 100%, 15%, 10% and 0% rates |
| Does the brand owner have an onshoring plan or a pricing agreement? | Company-specific rates can apply instead of the standard rate |
| Is the product a generic, a biosimilar or in a listed specialty category, and can you show it? | The 0% headings need the right declaration and supporting evidence |
| What happens to the price if generics are brought into scope in 2027? | Long supply agreements will outlast the review |
| Is the shipment for clinical, R&D or commercial use? | Non-commercial material has its own 0% heading |
How we can help
We match buyers with GMP-compliant API and finished-dose manufacturers across the main producing regions, including the EU, Switzerland, Japan, Korea and Asia. When you send an enquiry, tell us the destination market and whether the product is patented or generic there. That lets us shortlist suppliers whose origin and documents fit both the regulatory file and the tariff position.
You can browse our specialty and high-potency APIs, send an API enquiry, or request a quote for finished products. For a wider view of the market, see our United States market guide.
Sources: Presidential Proclamation of 2 April 2026 under Section 232; CBP CSMS #69395344 (30 July 2026); BIS notice on zero-rate specialty products, 91 FR 60360 (23 September 2026); law firm and customs broker summaries published April to September 2026. Rates and lists may change; confirm each entry with a licensed customs broker.
Frequently Asked Questions(FAQs)
Are generic medicines and APIs subject to the US Section 232 pharma tariff?
Not at present. Generics approved through an ANDA, therapeutically equivalent 505(b)(2) products, biosimilars and authorised generics, together with their ingredients, are exempt. Commerce has to report by April 2027 on whether tariffs on generics may be warranted.
Is an off-patent API covered if it goes into a patented medicine?
It can be. The tariff covers APIs and key starting materials used to make patented medicines listed in FDA's Orange Book or Purple Book, whether or not the API itself has a patent. Coverage follows the finished product.
What rate applies to medicines made in the EU or Japan?
Patented medicines from the EU, Japan, South Korea, Switzerland and Liechtenstein pay a combined rate of 15%, and UK products pay 10%. Most other origins pay 100% unless a company-specific rate or an exemption applies.
Are plasma-derived therapies and antibody–drug conjugates exempt?
Yes, at 0%, provided they come from one of the listed countries. Commerce confirmed this in a notice published on 23 September 2026. The same applies to orphan-only medicines, cell and gene therapies, nuclear medicines, fertility drugs, medical countermeasures and animal health products.
Do R&D samples and clinical trial material pay the tariff?
No. Material imported only for clinical trials, research and development or other non-commercial use has its own 0% heading. Document these shipments clearly as non-commercial.
