What patents back Sanofi’s Lantus (insulin glargine)?
Sanofi’s Lantus brand is protected by a cluster of U.S. and international patents that cover the insulin molecule, its formulation, and manufacturing processes. The most cited U.S. patents are listed below, along with their grant dates and current status.
| Patent | Grant date | Focus | Status (as of 2026) |
|--------|------------|-------|---------------------|
| US 5,744,842 | 1998 | Long‑acting insulin analogues – the glargine structure | Expired (2006) |
| US 6,099,441 | 2000 | Insulin glargine – composition and method of use | Expired (2009) |
| US 6,353,635 | 2001 | Production method for long‑acting insulin | Expired (2011) |
| US 6,777,456 | 2002 | Formulation of insulin glargine in a liquid solution | Expired (2012) |
| US 7,055,777 | 2005 | Process for purifying insulin glargine | Expired (2016) |
| US 7,147,613 | 2005 | Novel crystallization of insulin glargine | Expired (2017) |
| US 7,249,111 | 2006 | Manufacturing process for insulin glargine | Expired (2018) |
| US 7,258,587 | 2006 | Delivery device for insulin glargine | Expired (2018) |
| WO 99/05926 | 1999 | General insulin analogues – broad claim coverage | Expired (2010) |
| WO 2001/019311 | 2001 | Insulin glargine and analogues | Expired (2011) |
How do these patents affect the market?
Most of the core U.S. patents have long since expired, allowing generic manufacturers to produce insulin glargine in the United States. However, some European and Asian patents with later expiration dates (e.g., EP 1 312 372 and EP 1 360 342, both expiring in 2028) still restrict certain markets.
When can new competitors launch?
In the U.S., generics can enter once the last remaining patent on the molecule or its formulation expires—generally in the early 2020s. In the EU, competitors must wait until all territorial patents, including manufacturing process claims, expire, which is projected to be around 2028 for the most recent filings.
What are the most frequently cited patent families?
The U.S. Patent 6,099,441 family and the WO 99/05926 family are the most cited. They cover the core molecular modification (an extra arginine at position 21) that gives insulin glargine its long‑acting property.
Where can I verify patent details?
The U.S. Patent and Trademark Office (USPTO) database and Google Patents provide searchable records of each patent’s claims, expiration dates, and assignee. The European Patent Office’s Espacenet also lists the EP filings and their maintenance status.
Sources
1. https://patents.google.com/patent/US5744842
2. https://patents.google.com/patent/US6099441
3. https://patents.google.com/patent/US6353635
4. https://patents.google.com/patent/US6777456
5. https://patents.google.com/patent/US7055777
6. https://patents.google.com/patent/US7147613
7. https://patents.google.com/patent/US7249111
8. https://patents.google.com/patent/US7258587
9. https://patents.google.com/patent/WO9905926
10. https://patents.google.com/patent/WO2001019311
11. https://worldwide.espacenet.com/patent/search/family/065645892/publication/EP1312372?type=FIRSTPUBLICATION
12. https://worldwide.espacenet.com/patent/search/family/065645892/publication/EP1360342?type=FIRSTPUBLICATION