Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 113

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 113
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 January 2035 (PTE* pending)   |
| Later filed patent: coverage rangingthrough September 2042 (pending) | Later filed patent: coverage rangingthrough September 2042 (pending) | Later filed patent: coverage rangingthrough September 2042 (pending)         |                                         |
| Regulatory exclusivity: July 2035                                    | Regulatory exclusivity: November 2032                                | Regulatory exclusivity: March 2032                                           |                                         |

* PTE: Patent Term Extension. – SPC: Supplementary Protection Certificate. – PTA: Patent Term Adjustment. (a) Subject to legal challenge before EU General Court. Third-party patents and challenges to intellectual property Patents held or licensed by Sanofi do not in all cases provide effective protection against a competitor’s generic or biosimilar version of our products. For example, notwithstanding the presence of unexpired patents, competitors launched generic versions of Allegra in the US (prior to the product being switched to over-the-counter status) and Multaq in the EU. We caution the reader that there can be no assurance that we will prevail when we assert a patent in litigation and that there may be instances in which Sanofi determines that it does not have a sufficient basis to assert one or more of the patents mentioned in this report, for example in cases where a competitor proposes a formulation not appearing to fall within the claims of our formulation patent; a salt or crystalline form not claimed by our composition of matter patent; or an indication not covered by our method of use patent. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Legal and Regulatory Matters — We rely on our patents and other proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rights were limited, invalidated or circumvented, our financial results could be materially and adversely affected.” As disclosed in Item 8. of this annual report, we are involved in significant litigation concerning the patent protection of a number of our products. In addition to directly challenging our intellectual property rights, in some circumstances a competitor may be able to market a generic version of one of our products.

| 48 | SANOFIFORM 20-F2024 |

| PART I                             |
| ITEM 4. Information on the Company |

In the US, competitor generic companies can challenge patents by filing Abbreviated New Drug Applications (ANDAs) to receive authority to market a generic version of our approved products, by demonstrating that the purportedly generic version has the same properties