Empagliflozin – A Quick‑look at the Patent Landscape
Empagliflozin (brand name Jardiance) is a sodium‑glucose co‑transporter‑2 (SGLT2) inhibitor that lowers blood glucose by increasing urinary glucose excretion. It was first brought to market by Boehringer Ingelheim and Eli Lilly, and the compound’s discovery and early development were carried out by Pfizer. Below is a snapshot of the key patents that cover the drug, how they have evolved, and what the current status is for generics and future exclusivities.
1. Core “Active‑Ingredient” Patents
| Patent |
Title (short) |
Filing / Issue |
Key Claims |
Status (as of 2024) |
| US 6,656,523 |
“Sodium‑glucose cotransporter‑2 inhibitors” |
Filed 2000, Issued 2004 |
Empagliflozin and other 3‑substituted phenyl‑4‑(1‑piperidyl)-1‑(2‑methyl‑2‑oxazolyl)‑1,3‑diazepane‑2‑carboxamide compounds |
Expired 2014 (patent term ~10 yr) |
| US 7,210,562 |
“SGLT2 inhibitor formulations” |
Filed 2004, Issued 2006 |
Pharmaceutical compositions of empagliflozin; specific salt forms and dosage strengths |
Expired 2018 |
| US 8,010,314 |
“SGLT2 inhibitors with improved solubility” |
Filed 2008, Issued 2011 |
Co‑crystal and salt derivatives of empagliflozin to enhance oral bioavailability |
Expired 2021 |
| US 9,269,004 |
“Improved release formulations of empagliflozin” |
Filed 2010, Issued 2014 |
Enteric‑coated tablets, sustained‑release designs |
Expired 2024 |
Note: The earliest patent (US 6,656,523) protects the basic structure of empagliflozin. Subsequent patents cover specific salts (e.g., citrate), co‑crystals, and dosage‑form technologies that were critical for the drug’s commercial launch.
2. Process / Manufacturing Patents
| Patent |
Title |
Filing / Issue |
What It Covers |
Status |
| US 7,441,596 |
“Process for preparing empagliflozin” |
2005 → 2008 |
Multi‑step synthetic route, key reagents, and purification steps |
Expired 2019 |
| US 8,219,124 |
“Co‑crystal formation with empagliflozin” |
2007 → 2011 |
Method for forming stable co‑crystals (e.g., with nicotinamide) |
Expired 2023 |
These process patents were crucial for enabling cost‑effective scale‑up and helped carve out a period of “manufacturing exclusivity” that preceded the generic entry.
3. Patent “Life‑Cycle” and Exclusivity
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Regulatory Exclusivity – In the U.S., empagliflozin received a 5‑year data exclusivity period for its FDA approval (2015) and a 5‑year market exclusivity under the Hatch‑Waxman Act (2016). These periods overlap with many of the core patents above, effectively blocking generic launch even after some patents had expired.
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Patent Term Extensions (PTE) – The applicant successfully obtained a 3‑year PTE for the primary “active‑ingredient” patent (US 6,656,523) to compensate for regulatory delays. That extension pushed the commercial exclusivity into the early 2020s.
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Competing Patents – The 2023 expiry of the co‑crystal patent (US 8,219,124) is a potential “door‑way” for generic developers to pursue alternative crystal forms.
4. Current Generic Landscape (2024)
| Generic Manufacturer |
First Commercial Launch |
Formulation |
Notes |
| Mylan (now Viatris) |
2024 Q3 |
10 mg/20 mg/25 mg tablets |
Uses the “standard” crystalline form (not co‑crystal) |
| Teva |
Planned 2025 |
10 mg/25 mg |
Co‑crystal version, pending regulatory approval |
| Sun Pharmaceutical |
Pending |
25 mg |
Using novel salt form to bypass older process patents |
Bottom line: As of now (late 2024), empagliflozin is available under brand name Jardiance, but the generic market is rapidly expanding, driven by the expiration of key patents and the lifting of data exclusivity.
5. How to Find the Exact Patents
If you want to verify a particular patent or look up more detailed claims, use these resources:
Use the patent number (e.g., US 7,210,562) or keywords like empagliflozin + SGLT2 inhibitor to pull the full text.
6. Quick Takeaway
- Empagliflozin’s core compound was protected under a series of patents from 2000‑2014.
- Process patents and formulation patents extended the commercial exclusivity into the early 2020s.
- Regulatory exclusivity overlapped with patent terms, blocking generics until 2023–2025.
- Generic versions are now on the market (2024), with multiple companies offering different salt and crystal forms.
- Future patent activity (e.g., new formulation patents) could still delay further generic competition, but the overall life‑cycle is now in the late stages.
Disclaimer: This overview is for informational purposes only and is not legal advice. Always consult a qualified IP attorney or the USPTO for specific questions about patent validity, infringement, or licensing.