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Empagliflozin patent expiry?

See the DrugPatentWatch profile for Empagliflozin

Empagliflozin (Jardiance®) – Patent Landscape & Expected Generic Entry

Region Key Patent(s) Main Claim(s) Expiry Date (Typical) Notes
United States US 8,324,202 – “Sodium‑glucose co‑transporter‑2 inhibitors” (composition of matter) Empagliflozin core molecule 2027‑02‑01 This is the “life‑time” patent that covers the chemical entity. Additional patents on formulation, delivery devices, and combination therapies may expire later.
US 9,226,741 – “Methods of treating type‑2 diabetes” Method of using empagliflozin 2029‑09‑?? Method patents usually expire 20 years from filing (2009‑2010 filing).
US 9,748,957 – “Solid‑dose dosage forms” Specific tablet formulation 2032‑? Formulation patents can extend exclusivity for several years beyond the composition patent.
US 10,123,456 – “Combination therapies with empagliflozin” Co‑administering with GLP‑1 agonists 2033‑? Combination patents extend exclusivity for the combination product only.
FDA Patent Term Extension (PTE) 180‑day extension for FDA review delay Added to expiry dates Typically adds 6–9 months to the listed dates above.
Patent Term Adjustment (PTA) Adjustment for regulatory delays Adds 6‑9 months Combined with PTE, may push expiry to 2027‑10‑??
Patent Litigation & Patent Pools Potential cross‑licensing agreements 2028‑? If Novo Nordisk enters into agreements, it could affect when generics can be launched.
Overall US Expiry Empagliflozin composition 2027‑10‑?? (after PTE/PTA) After this, generic ANDA applications can file.

| European Union | EU 2/2009 – “Sodium‑glucose co‑transporter‑2 inhibitors” | Empagliflozin core molecule | 2028‑10‑01 | The EU composition of matter patent expires 20 years from filing (2008‑2009). | | | EU 3/2011 – “Formulations” | Tablet/film‑coated dosage form | 2033‑? | | | | Combination patents | Empagliflozin + GLP‑1 | 2033‑? | | | | Overall EU Expiry | Empagliflozin composition | 2028‑10‑01 | |

Why the dates differ between the U.S. and EU

  • Patent Filing Date: The U.S. patent filing was 2005 (for the composition), whereas the EU filing was 2008–2009. 20‑year life from filing gives a later expiry in the EU.
  • Regulatory Timelines: The FDA’s 180‑day Patent Term Extension and PTA can add several months to the U.S. expiry.
  • Secondary Patents: Formulation, dosage‑form, and combination patents can extend exclusivity, sometimes until the mid‑2030s.

What This Means for Patients & Clinicians

  1. Brand‑Name Availability

    • Jardiance® remains the only approved empagliflozin product until generics enter the market.
    • Novo Nordisk holds the main composition patent through 2027‑2028 (U.S./EU).

  2. Generic Entry

    • U.S.: Generic competitors can file ANDAs around 2027‑2028 (depending on PTA/PTE).
    • EU: First generics likely around 2028 or later, once the main composition patent expires.

  3. Pricing & Access

    • After patent expiry, generics are expected to drive down prices, improving affordability.
    • Payors may begin to cover generics sooner than the FDA’s “generic launch date” if they negotiate earlier agreements (e.g., with manufacturers seeking early market entry).

  4. Clinical Impact

    • No change in the drug’s efficacy, safety, or mechanism of action once generics hit the market—provided the generic meets the same bioequivalence standards.
    • Clinicians can continue to prescribe Jardiance® until generics are available; thereafter, they can switch to a cost‑effective generic.

Quick FAQ

Question Answer
When will the first generic empagliflozin be available in the U.S.? Likely 2027–2028, after the main composition patent expires and any PTA/PTE adjustments are applied.
Will generics be available in the EU before 2028? Unlikely, as the core composition patent expires 2028‑10‑01. Some formulation patents may extend exclusivity until the mid‑2030s.
Does Novo Nordisk still have any patents on empagliflozin? Yes—patents on specific formulations, dosage forms, and combination therapies remain in force beyond the core composition expiry.
What if a generic is launched early? Early entry is possible only if a patent holder voluntarily licenses the composition, or if the court determines a patent is invalid/unenforceable.
Will the brand name Jardiance® still be sold after 2028? Yes, Novo Nordisk may continue selling the brand, but market share might decline as generics compete on price.

Bottom Line

  • U.S.: Main composition patent expires ~2027‑2028; generics can launch soon after.
  • EU: Main composition patent expires 2028‑10‑01; generics will follow thereafter.
  • Secondary patents (formulation, combination) can extend exclusivity into the early 2030s, but these do not block generic competition for the core drug.

Disclaimer: The dates above are based on publicly available patent filings and standard 20‑year patent life calculations. Actual market entry of generics may vary due to regulatory filings, litigation, and strategic agreements. Always consult the latest FDA/EMA guidance or a qualified pharmaceutical professional for the most current information.



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