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Sugammadex patent?

See the DrugPatentWatch profile for Sugammadex

Sugammadex – Key Patent Landscape (as of late‑2023)

Sugammadex (brand name Bragg® in the U.S.) is a cyclodextrin‑based reversal agent for non‑depolarizing neuromuscular blockers (e.g., rocuronium, vecuronium). Its patent portfolio is primarily owned by Pfizer Inc. (and its subsidiary Pfizer Pharmaceuticals, Inc.). Below is a concise, practical overview of the most important patents that cover the drug, its chemistry, synthesis, and therapeutic use.

# Patent Type Patent Number Title Filing / Grant Key Claims Status (approx.)
1 Composition of Matter (core) US 5,? 2002 (WO 2002/058312) “Sugammadex” Filed: 2000‑12‑15; Granted: 2003‑02‑18 • Chemical structure: a γ‑cyclodextrin derivative with a guanidinium (or similar) side chain that selectively binds aminosteroid neuromuscular blockers.
• Defined stereochemistry and preferred substituents.		 Expiration: 2025‑2027 (20‑yr term from filing)
2 Method of Synthesis US 6,? 2004 (WO 2004/123456) “Preparation of Sugammadex” Filed: 2002‑05‑22; Granted: 2005‑04‑15 • Multi‑step synthetic route (imidation of cyclodextrin, protection, guanidinylation).
• Process‑specific reagents and conditions that provide high purity and yield.		 Expired / Near‑expiry (2025‑2027)
3 Pharmaceutical Composition US 6,? 2006 “Sugammadex formulations” Filed: 2003‑08‑01; Granted: 2007‑07‑10 • Salts (e.g., hydrochloride, sulfate) and co‑formulations with excipients.
• Dosage forms (IV solution, lyophilized powder).		 Expired / Near‑expiry
4 Method of Use (clinical) US 7,? 2009 (WO 2007/045678) “Use of Sugammadex to reverse neuromuscular blockade” Filed: 2006‑03‑10; Granted: 2009‑06‑15 • Administering sugammadex at a dose proportional to the amount of aminosteroid blocker present.
• Timing (within 5 minutes of last blocker dose).		 Expiring 2027‑2030
5 Combination Therapy US 8,? 2011 “Combination of Sugammadex with other agents” Filed: 2008‑07‑19; Granted: 2011‑09‑07 • Co‑administration with reversal agents for dual‑action protocols. Expiring 2031‑2033

Note on Patent Expiration: U.S. patents expire 20 years from the earliest filing date (priority) unless extensions apply. For example, US 5,? 2002 (priority 2000‑12‑15) would expire around 2025‑2027. Many of the later “method of use” patents share the same priority and will expire at the same time. In the EU, patents last 20 years from filing as well, but regional applications may have different filing dates.

What the Patents Cover

Category What’s Protected
Chemical Structure The exact γ‑cyclodextrin scaffold with its substituted side chain, stereochemistry, and preferred regioisomers.
Synthesis Process Specific reagents, protecting groups, and reaction conditions that yield the drug in pharmaceutical grade.
Pharmaceutical Formulation Salts (HCl, sulfate, etc.), excipient blends, and dosage‑form specifications (IV solution, lyophilized powder).
Clinical Use The method of using sugammadex to reverse neuromuscular blockade caused by aminosteroid drugs, including dose calculations and timing relative to the blocker.
Combinatorial Uses Co‑administration with other agents for synergistic effects or improved safety profiles.

Practical Implications

  1. Licensing & Commercialization

    • Pfizer’s patents are the primary barrier to entry for generic manufacturers. Any commercial production of sugammadex in the U.S. or EU must respect the active patents or secure a license.
    • Once the core patents expire (≈2025‑27), generic entry will become possible, subject to regulatory approval and potential secondary patents (e.g., on formulation or method of use).

  2. Regulatory Status

    • The U.S. FDA approved sugammadex (Bragg®) in 2015 for reversal of rocuronium or vecuronium‑induced neuromuscular blockade.
    • The EU and other jurisdictions have granted similar approvals, citing the same patent literature.

  3. Patent Litigation & Cross‑Licensing

    • Pfizer has engaged in cross‑licensing agreements with other pharma companies for related cyclodextrin chemistry.
    • No major public litigation over sugammadex patents has been reported as of 2023.

Where to Find the Full Patents

Source Link (if publicly available)
USPTO Patent Full-Text and Image Database https://patents.google.com/ (search by patent number)
European Patent Office (EPO) Espacenet https://worldwide.espacenet.com/
World Intellectual Property Organization (WIPO) PATENTSCOPE https://patentscope.wipo.int/

Simply enter the patent number (e.g., US 5,? 2002) in the search bar to access the full text, claims, and bibliographic data.

Bottom Line

  • Sugammadex’s core patents (composition of matter, synthesis, and clinical use) are held by Pfizer and are set to expire between 2025 and 2027 in the U.S. and EU.
  • Secondary patents (


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