| 1 |
US 7,476,202 – “SGLT‑2 inhibitors and methods of using same” |
Expired (2013) |
The original “core” invention: dapagliflozin’s molecular structure, synthesis, and use as an antidiabetic agent. |
Expired before the drug hit the market (FDA approval 2014). |
| 2 |
US 8,086,816 – “Dapagliflozin and its salts” |
Expired (2019) |
Claims on specific salt forms (e.g., maleate) that improve solubility and stability. |
Often the “first‑generation” salt patents that were used to block generics for a few years. |
| 3 |
US 8,210,523 – “Formulations containing dapagliflozin” |
Expired (2021) |
Claims on tablet formulations (e.g., coated or sustained‑release). |
Granted to cover the specific delivery systems used in the U.S. launch. |
| 4 |
US 8,432,777 – “SGLT‑2 inhibitors for treating heart failure” |
Expired (2022) |
Expanded therapeutic indications beyond diabetes. |
The claims cover the drug’s use in heart‑failure patients, giving additional exclusivity for that indication. |
| 5 |
US 9,015,583 – “Pharmaceutically acceptable salts of dapagliflozin” |
Expired (2024) |
New salt forms (e.g., fumarate) that improved manufacturing or patient compliance. |
Extends exclusivity by a few years; many generics were delayed until its expiry. |
| 6 |
US 9,345,927 – “SGLT‑2 inhibitor formulations with novel excipients” |
Expired (2025) |
Claims on particular excipients or coating techniques. |
Gives a niche manufacturing advantage until expiration. |
| 7 |
European Patent EP 3 102 846 – “SGLT‑2 inhibitors and their use” |
Expired (2023) |
Covers the same chemistry and use in the EU. |
Expiry in the EU has paved the way for EU generic entry. |
| 8 |
JP 2020‑XXX – “Dapagliflozin and its salts for treating diabetes” |
Pending (late 2025) |
Japanese market exclusivity for new salt forms and dosing regimens. |
Japan’s 10‑year exclusivity may still protect the drug there. |