Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 112

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 112
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 Emerging markets One of the main limitations on our operations in emerging market countries is the lack of effective intellectual property protection or enforcement for our products, which frequently do not provide non-patent exclusivity for innovative products. While the situation has gradually improved, the lack of protection for intellectual property rights or the lack of robust enforcement poses difficulties in certain countries. Additionally, in recent years a number of countries have waived or threatened to waive intellectual property protection for specific products, for example through compulsory licensing of generics. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Sanofi’s Structure and Strategy — The globalization of our business exposes us to increased risks in specific areas”. Product and patent overview We summarize in the table below the intellectual property coverage (in some cases through licenses) of our most significant marketed products in terms of sales, in our major markets. In the discussion of patents below, we focus on active ingredient patents (compound patents) and, in the case of NCEs, on any later filed patents listed as applicable in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) or in its foreign equivalents. For biologics, the Orange Book listing does not apply. The table provides a list of expiration dates, which include six-month pediatric extensions when applicable, and when indicated, extensions due to Patent Term Adjustment (PTA) or other regulatory delays. Where patent terms have expired we indicate such information and mention whether generics or biosimilars are on the market. We do not provide later filed patent information relating to formulations already available as an unlicensed generic. References below to patent protection in Europe indicate the existence of relevant patents in most major markets in the EU. Specific situations may vary by country. We additionally set out any regulatory exclusivity from which these products continue to benefit in the EU, US or Japan. Regulatory exclusivities presented below incorporate any pediatric extensions obtained. While EU regulatory exclusivity is intended to be applied throughout the EU, in some cases Member States have taken positions prejudicial to our exclusivity rights.

|                                                                                               | United States                                                         | European Union                                                                                                                | Japan                             |
| Dupixent                                                                                      | Compound: March 2031 with PTE*                                        | Compound: September 2032 with SPC*(March 2033 with pediatric extension ofSPC* in process of being granted acrossEU countries) | Compound: May 2034 with PTE*      |
| Later filed patents: coverage rangingthrough March