When is farxiga patent loss in the us?

Farxiga (dapagliflozin) – U.S. patent landscape

These are the U.S. patents that are currently cited in the FDA’s “Patent and Exclusivity” tables for dapagliflozin.

What this means for generic entry

1. Patent‑based exclusivity

   • The earliest a generic applicant could challenge the patents and obtain marketing approval is after the last of the main patents expires.
   • With the above dates, the most conservative estimate for the end of patent protection is mid‑2029.

2. Orphan‑drug and data‑exclusivity

   • Dapagliflozin was granted 5‑year FDA product exclusivity (2014‑2019) and an additional 5‑year “Orphan Drug” exclusivity for a type 1‑diabetes indication (2019‑2024).
   • These exclusivities do not affect the patent dates; they only affect when the FDA can approve a generic that meets all regulatory requirements.

3. Pending applications

   • Amgen/Genentech have filed “patent term extensions” on some of the 2012‑2013 patents that could push the expiration dates up to 2025‑2026 if the FDA approves the extensions.
   • They have also filed new patents on improved formulations (e.g., once‑daily dosing, combination with insulin) that will add extra years of protection until 2029‑2030.

4. Practical outcome

   • No generic Farxiga is currently approved in the United States.
   • The earliest likely entry—assuming no invalidation challenges—is late 2025 (when the 2012 patents expire).
   • If the 2014‑2015 patents are extended or the new formulations are granted, generic entry could be delayed until mid‑2029.

Bottom line

• Patent expirations: 2025 for the 2012‑2013 patents, 2028 for the 2011 patent on the original formulation, 2029 for the 2014 patent on the new formulation.
• Generic entry window: Late 2025–2026 if the company does not obtain further extensions; mid‑2029 if the newer patents remain in force.
• Current status: No FDA‑approved generic Farxiga as of 2024.

Quick reference

Feel free to ask if you’d like more details on any specific patent, the generic approval process, or how these dates might affect your prescribing practice!