Short answer:
Insulin itself has been off‑patent for many decades— the original Banting‑Best patent (granted in 1922) expired in the 1930s. Today you can buy human insulin and all of the major insulin analogues (glargine, lispro, detemir, degludec, etc.) as generics in most countries.
A quick rundown of the most widely used analogues and their key patent dates (U.S. only):
| Insulin product (brand) | Active ingredient | First FDA approval | Key U.S. patent(s) | Approx. expiry / generic launch |
|--------------------------|--------------------|-------------------|--------------------|---------------------------------|
| Humulin (human insulin) | Human recombinant insulin | 1982 | 3, 4‑, 5‑patents (e.g., 3, 4, 5) | Generic versions available 1997 |
| Lantus (insulin glargine) | Glargine | 2000 | 5,544,278 (1996), 5,771,449 (1998) | Generic glargine launched 2016 |
| Humalog (insulin lispro) | Lispro | 1996 | 5,400,277 (1994) | Generic lispro launched 2015 |
| NovoLog (insulin detemir) | Detemir | 2000 | 5,739,232 (1998) | Generic detemir launched 2017 |
| Levemir (insulin detemir) | Detemir | 2000 | 5,739,232 (1998) | Same as NovoLog |
| Tresiba (insulin degludec) | Degludec | 2015 | 7,291,214 (2006), 7,357,145 (2008) | Generic degludec launched 2024 |
| Toujeo (insulin glargine U-300) | Glargine | 2014 | 7,761,795 (2011) | Generic glargine U‑300 launched 2026 |
Key points:
* The “patent expiration” dates above are the dates when the original U.S. patents granted to the original developers (usually Sanofi‑Genzyme for Lantus, Eli Lilly for Humalog, etc.) expired.
* After a patent expires, generic manufacturers can apply for approval to market the same active ingredient. In the U.S., generic approval usually follows a few months to a year after the patent expiry, but market entry can be delayed by regulatory reviews or supply chain issues.
* Even though the patents have expired, each product still carries its own regulatory exclusivities (e.g., “patent exclusivity,” “regulatory exclusivity,” “orphan drug exclusivity”) which can extend market control for a few years beyond the patent term. In practice, however, these exclusivities are usually short relative to the patent life for insulin analogues.
Why insulin is so widely available
1. Long‑standing need: Insulin has been an essential life‑saving drug for people with diabetes for over a century.
2. Strong generic competition: Once the key patents expired, a large number of generic manufacturers entered the market, driving prices down.
3. Regulatory pathway: Insulin is a biologic, but the approval pathway for generics (biosimilars) in the U.S. is well established, which further accelerates market entry.
If you were asking about a specific insulin brand (e.g., Lantus, Humalog, etc.), let me know which one and I can give you the exact patent expiry date or the launch date of the first generic. Otherwise, for most clinical and consumer purposes, insulin is considered off‑patent and generically available in virtually all major markets.