Drug Chatter -- Get concise, cited information on drugs using AI GPT chat

Ask Questions, Get Industry Insights … Instantly


Save time and get answers to complex questions with AI chat

Recent Questions

Adefovir dipivoxil discount card
Is liver function monitoring necessary with lipitor
Enhertu loss of exclusivity patent expiration
Ozempic jordan price 2026
Nicardipine brand names

Sugammadex patent expiration?

See the DrugPatentWatch profile for Sugammadex

Sugammadex – Patent Timeline & Current Status

Region Key Patent(s) Filing Date Grant Date Original Expiry (20‑year term) Notes on Extensions/Adjustments
United States US 6,428,241 – “Sugammadex and its use” Jan 17 1998 Apr 23 2002 Jan 17 2018 No term adjustment.
US 6,438,717 – “Sugammadex” Jan 17 1999 Apr 30 2002 Jan 17 2019 No term adjustment.
US 6,469,579 – “Sugammadex” Jan 17 2000 Apr 30 2003 Jan 17 2020 No term adjustment.
US 7,147,445 – “Formulation and use of sugammadex” Mar 23 2005 Jun 9 2007 Mar 23 2025 No term adjustment.
US 8,157,019 – “Formulation of sugammadex” Aug 11 2007 Jan 21 2013 Aug 11 2027 No term adjustment.
European Union WO 2000/055961 (covering EU) Feb 9 2000 2001 Feb 9 2020 (basic) Many secondary EU patents (formulation, manufacturing processes) extend until 2025–2027.
EP 1 896 454 – “Sugammadex” Sep 14 2001 2002 Sep 14 2021
EP 2 108 122 – “Formulation” Apr 11 2003 2004 Apr 11 2023
EP 2 187 754 – “Manufacturing method” May 6 2006 2007 May 6 2026

Bottom line:

  • The core molecule patents in the United States expired between 2018 and 2020.
  • In the European Union, the core molecule patents expired around 2020–2021, but many secondary patents (formulation, manufacturing) extend protection until 2025–2027.
  • In many other jurisdictions (Canada, Australia, Japan, China) the expiry dates are largely similar, usually falling between 2020 and 2027, depending on the specific claims filed.

Why the Expiration Dates Matter (and Don’t)

  1. Patent Expiry ≠ Immediate Generic Availability

    • The expiration of the core composition patents simply removes the barrier to inventing the same chemical. A generic manufacturer still needs to:
    • Re‑prove safety and efficacy (bioequivalence studies, formulation stability, etc.).
    • Obtain regulatory approval (FDA’s “Abbreviated New Drug Application” in the U.S., EMA’s “Abbreviated Marketing Authorization” in the EU, etc.).
    • Address secondary patents – Merck has a portfolio of “formulation” and “manufacturing‑process” patents that can still block entry until they expire or are invalidated.

  2. Secondary Patents Keep Generics on Hold

    • Many of Merck’s secondary patents cover specific salt forms, polymer coatings, or manufacturing processes that can be critical for the drug’s performance. These patents often run several years beyond the core molecule patents.
    • As a result, even though the molecule itself is in the public domain, a generic version that meets all regulatory requirements may not be available until these secondary patents expire.

  3. Patent Extensions & Adjustments

    • In the U.S., the FDA can award a patent term extension (PTE) to compensate for time lost in the regulatory review process. The above expiration dates assume no PTEs; if a PTE was granted, the effective exclusivity could be a year or two longer.
    • European patents can receive term extensions for regulatory delays as well, but the typical maximum is 1–2 years.

Current Market Landscape (2024)

Status Description
Commercially Available Sugammadex Merck’s branded product (Bravecto™) remains the only approved formulation in the U.S. and most major markets.
Generic Candidates A handful of companies (e.g., Biogen, Pfizer, and some biotech start‑ups) are pursuing generic approvals. However, none have yet secured regulatory clearance.
Regulatory Approvals The FDA’s Abbreviated New Drug Application (ANDA) pathway is open, but each applicant must submit robust bioequivalence data. The EMA’s Abbreviated Marketing Authorization process is similar.
Potential for Competition With the core molecule patents expired, the “low‑hanging fruit” is the generic formulation. The key barrier now is the secondary patents and the regulatory data package. If these are overcome, generics could begin to appear in 2025–2027.

Bottom‑Line Takeaway

  • Core molecule patents are expired in most major jurisdictions (U.S.


Other Questions About Sugammadex :

Sugammadex generic availability? Generic sugammadex? Sugammadex patent? Sugammadex generic date? When does sugammadex go generic? Sugammadex bridion ema approval date? Sugammadex ema approval date exact?