Table 2. Litigated Patents on GLP-1 Receptor Agonist Drug-Device Combinations.
Product | No. of lawsuits | No. of patents involved in lawsuitsa | No. (%) of device patents involved in lawsuits |
---|---|---|---|
Byetta (exenatide) | 2 | 8 | 0 |
Victoza (liraglutide) | 13 | 8 | 4 (50) |
Saxenda (liraglutide) | 5 | 25 | 18 (72) |
Ozempic (semaglutide) | 8 | 24 | 18 (75) |
Wegovy (semaglutide) | 2 | 5 | 0 |
Total | 30 | 70 | 40 (57) |
Whenever a firm seeks US Food and Drug Administration approval for a generic version of a brand-name drug with active patents listed in the Orange Book, the generic firm must certify that all patents are invalid, unenforceable, or not infringed by their product (paragraph IV certification). The brand-name firm may then sue the generic firm for patent infringement following a paragraph IV certification. This column lists all patents included in litigation by brand-name firms against generic firms following paragraph IV certifications. Note that a single patent counts more than once if litigated by brand-name firms on more than 1 glucagon-like peptide 1 (GLP-1) receptor agonist.