Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 111

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 111
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 listed drug. • Significant new uses of existing NCEs, including new indications, may qualify for an additional three years of regulatory exclusivity if certain conditions are met. • For biological drugs, the FDA may not approve a biosimilar application until 12 years after the date on which the reference product was first licensed. • Pediatric extensions are available under certain conditions of the Hatch-Waxman Act by providing data on pediatric studies. Under such cases the FDA allows for an extension of regulatory exclusivity and patent life by six months, to the extent these protections have not already expired (the so-called “pediatric exclusivity”). • Orphan drug exclusivity may be under certain circumstances to drugs intended to treat rare diseases or conditions. European Union • Regulatory exclusivity is available in two forms: data exclusivity and marketing exclusivity. • Generic or biosimilar drug applications will not be accepted for review until eight years after the first marketing authorization (data exclusivity). This eight-year period is followed by a two-year period during which generics or biosimilars cannot be marketed (marketing exclusivity). • The marketing exclusivity period can be extended to three years if, during the first eight-year period, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which are deemed to provide a significant clinical benefit over existing therapies. This is known as the “8+2+1” rule. • Pediatric extensions - A regulation on pediatric medicines provides for pediatric research obligations with potential associated rewards including extension of supplementary patent protection and six-month regulatory exclusivity for pediatric marketing authorization (for off-patent medicinal products). • Orphan drug exclusivities also exist in the EU.

| 46 | SANOFIFORM 20-F2024 |

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

Japan • The regulatory exclusivity period varies, but is generally four to six years for drugs for a specific use, and for medicinal products with new indications or with new dosages; eight years for drugs containing a new chemical entity; ten years for orphan drugs, and for new drugs requiring pharmaco-epidemiological study; six to eight years for innovative drugs (“SAKIGAKE” products), and for orphan drugs with a new ethical combination or new mode of administration; and six years for other medicinal products, such as new prescription combination drugs or drugs requiring a new mode of administration. • There is no pediatric research extension of patent protection for patented medicinal products. However, regulatory exclusivity may be extended from eight to ten years.