Short answer:
The original insulin patents expired long ago (early‑to‑mid‑1940s).
*Most of the insulin analogs that dominate the market still have active patents; their expiration dates range from the early‑2010s to the late‑2020s.
*Below is a quick‑reference table of the major U.S. insulin analogs and their U.S. patent expiration dates (or first generic approvals, which usually align with patent expiry). Note that dates can differ slightly by country and by specific formulation.
| Insulin product (brand) | Primary molecule | First generic approval (U.S.) | Approx. U.S. patent expiration | Notes |
|--------------------------|------------------|------------------------------|--------------------------------|-------|
| Humulin R / Lantus (glargine) | Insulin glargine | 2012 (generic) | 2012 (patents expired 2011‑2012) | Several patents on formulation and delivery method expired around 2011. |
| Humalog (lispro) | Insulin lispro | 2016 | 2016 (patents expired 2015‑2016) | The key patent on lispro itself expired 2015. |
| NovoLog (aspart) | Insulin aspart | 2018 | 2018 (patents expired 2017‑2018) | Patents covering the amino‑acid substitution and delivery methods expired 2017. |
| Apidra (glulisine) | Insulin glulisine | 2016 | 2016 (patents expired 2015‑2016) | Patents on the amino‑acid sequence and formulation expired 2015. |
| Tresiba (degludec) | Insulin degludec | 2020 (U.S. generic approval pending) | 2028‑2030 (patents still active) | Patents covering degludec’s multimeric structure and delivery expire 2028‑2030. |
| Byetta (exenatide) | (not insulin, but often paired) | 2014 | 2019‑2021 (patents expired) | For context—most GLP‑1 analogs’ patents expired. |
Key points
1. Original insulin (porcine or bovine)
* First patents (U.S. 1,169,423 and 1,169,424, filed 1916) expired in 1936–1939.
* Recombinant human insulin patents (e.g., U.S. 4,442,828, filed 1978) expired 1998–2000.
2. Insulin analogs
* Each analog has a set of “core” patents (on the amino‑acid change) and secondary patents (on formulation, delivery devices, and specific dosing regimens).
* Generics could enter the market only after all relevant patents expired or were invalidated.
3. Country‑specific differences
* Patents can be granted for different formulations and delivery devices, so expiration dates may differ between the U.S., EU, Japan, etc.
* For instance, in the EU Lantus went generic in 2018, a year later than in the U.S.
4. Current status
* As of 2026, most insulin analogs are off‑patent in the U.S., allowing multiple generic manufacturers to produce them.
* Newer analogs (degludec, insulin degludec‑aspart) are still under patent protection until the early‑2030s.
Bottom line – If you’re looking for a specific insulin product’s patent status, check the USPTO database or the local national patent office. The general trend is that insulin itself is no longer patented, while the modern analogs are gradually expiring, with most having already gone generic in the U.S. (but some, like degludec, remain patent‑protected into the next decade).