Millions of people in the U.S. rely on insulin. (1) Since 1996, pharmaceutical corporations have increased the price of a vial of insulin from $21 to more than $275. (2) Confronted with industry price-gouging, nearly a quarter of patients who rely on insulin to survive have reported rationing it. (3) Since 2017, at least 12 people in the United States have died from rationing insulin. (4)
There are many different kinds of insulin. Some insulins have seen follow-on, biosimilar, and interchangeable competition, but others are sold exclusively by one corporation. (5) While patents on the insulin compound have expired for some products, patent monopolies on drug-device combinations (e.g., insulin pens) can continue to delay the development of competitor products, keeping prices high. According to a 2020 study, the Big Three insulin manufacturers (Eli Lilly, Sanofi, and Novo Nordisk) all had patents on delivery devices. (6) For example, while Novolog (insulin apart) is no longer covered by patents, the FlexPen typically used to deliver the insulin is covered by three patents. These device patents extend the effective monopoly on the drug.
Novo Nordisk FlexPen patents (7)
| Patent Number | Patent Expiration |
| 7,762,994 | 06/20/2031 |
| 8,579,869 | 06/30/2023 |
| 9,265,893 | 09/23/2032 |
The U.S. government can ease barriers to more affordable insulin by authorizing biosimilar manufacturers to use insulin-related patents, including device patents. This will help lower uncertainty and costs for potential competitors, and can pave a faster path to regulatory approval. The U.S. government can also take other steps to bolster access. The U.S. government can undertake public manufacturing of insulin, and investigate potential price-fixing among the three dominant insulin manufacturers. (8)
(1) https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html#
(2) Public Citizen, T1International, Legislative Guide for Insulin for All (2020), https://www.citizen.org/article/legislative-guide-for-insulin-for-all/
(3) https://www.t1international.com/blog/2021/10/18/t1international-survey-diabetes-covid-rationing/.
(4) Public Citizen, T1International, Legislative Guide for Insulin for All (2020), https://www.citizen.org/article/legislative-guide-for-insulin-for-all/
(5) Insulin lispro, insulin glargine.
(6) Sanofi Solostar, Eli Lilly Humalog Kwikpen, Novolog FlexPen. https://academic.oup.com/jlb/article/7/1/lsaa061/5918811.
(7) https://www.novonordisk-us.com/products/product-patents.html
(8) https://investigateinsulinnow.com/ and https://www.statnews.com/pharmalot/2021/03/29/ftc-insulin-diabetes-lilly-novo-sanofi-antitrust/. https://www.washingtonpost.com/opinions/elizabeth-warren-its-time-to-let-the-government-manufacture-generic-drugs/2018/12/17/66bc0fb0-023f-11e9-b5df-5d3874f1ac36_story.html