Table 1:
FDA-approved GLP-1 receptor agonists, 2005-2021a
| Product | Version | FDA approval date | Active ingredient | Indicationb | Manufacturer | First patent filing listed with the FDA | Time from first patent filing to initial FDA approval (years) | First paragraph IV certificationc | Time from initial FDA approval to first paragraph IV certification (years) |
|---|---|---|---|---|---|---|---|---|---|
| Byetta | Byetta (300mcg/1.2mL) | 4/28/2005 | exenatide | Glycemic control in Type 2 diabetes | AstraZeneca | 5/24/1993 | 11.9 | 6/11/2014 | 9.1 |
| Byetta (600mcg/2.4mL) | 4/28/2005 | ||||||||
| Victoza | Victoza (6mg/mL) | 1/25/2010 | liraglutide | Glycemic control in Type 2 diabetes; reduced risk of major adverse cardiovascular events in Type 2 diabetes and established cardiovascular disease | Novo Nordisk | 1/28/1999 | 11.0 | 12/12/2016 | 6.9 |
| Bydureon | Bydureon (2mg/vial) | 1/27/2012 | exenatide | Glycemic control in Type 2 diabetes | AstraZeneca | 5/24/1993 | 18.7 | NA | NA |
| Bydureon Pen (2mg/vial) | 2/28/2014 | ||||||||
| Bydureon BCise (2mg/0.85mL) | 10/20/2017 | ||||||||
| Saxenda | Saxenda (6mg/mL) | 12/23/2014 | liraglutide | Weight management in obesity | Novo Nordisk | 2/26/1999 | 15.8 | 8/16/2021 | 6.6 |
| Adlyxin | Adlyxin (0.05mg/mL) | 7/27/2016 | lixisenatide | Glycemic control in Type 2 diabetes | Sanofi | 12/2/2008 | 7.7 | NA | NA |
| Adlyxin (0.1mg/mL) | 7/27/2016 | ||||||||
| Xultophy | Xultophy (3.6mg/mL) | 11/21/2016 | insulin degludec/liraglutide | Glycemic control in Type 2 diabetes | Novo Nordisk | 11/21/2016 | 17.7 | NA | NA |
| Soliqua | Soliqua (33mcg/mL) | 11/21/2016 | insulin glargine/lixisenatide | Glycemic control in Type 2 diabetes | Sanofi | 11/21/2016 | 10.4 | NA | NA |
| Ozempic | Ozempic (2mg/1.5mL) | 5/12/2017 | semaglutide | Glycemic control in Type 2 diabetes; reduced risk of major adverse cardiovascular events in Type 2 diabetes and established cardiovascular disease | Novo Nordisk | 1/2/2002 | 15.9 | 12/6/2021 | 4.0 |
| Ozempic (2mg/1.5mL) | 12/5/2017 | ||||||||
| Rybelsus | Rybelsus (3mg) | 9/20/2019 | semaglutide | Glycemic control in Type 2 diabetes | Novo Nordisk | 3/20/2006 | 13.5 | NA | NA |
| Rybelsus (7mg) | 9/20/2019 | ||||||||
| Rybelsus (14mg) | 9/20/2019 | ||||||||
| Wegovy | Wegovy (0.25mg/0.5mL) | 6/4/2021 | semaglutide | Weight management in obesity | Novo Nordisk | 3/20/2006 | 15.2 | NA | NA |
| Wegovy (0.5mg/0.5mL) | 6/4/2021 | ||||||||
| Wegovy (1mg/0.5mL) | 6/4/2021 | ||||||||
| Wegovy (1.7mg/0.75mL) | 6/4/2021 | ||||||||
| Wegovy (2.4mg/0.75mL) | 6/4/2021 |
FDA: Food and Drug Administration; T2DM: Type 2 diabetes mellitus; MACE: Major adverse cardiovascular events
Two brand drugs, dulaglutide and albiglutide, are not included in this table nor in the analysis because they were regulated as biologics at the time of approval.
All indications included on FDA labels through the end of 2022 are listed here.
Firms seeking approval for generic versions of brand-name drugs must file paragraph IV certifications in cases when the brand-name reference drug has active patents listed in the Orange Book. When filing a paragraph IV certifications, generic firms must attest that all patents listed in the Orange Book on the brand-name reference drug are invalid, unenforceable, or not infringed by the generic product.