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Last Updated: March 19, 2026

sugammadex sodium - Profile


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What are the generic drug sources for sugammadex sodium and what is the scope of patent protection?

Sugammadex sodium is the generic ingredient in two branded drugs marketed by Msd Sub Merck, Aspiro, B Braun Medical, and Zydus Pharms, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Sugammadex sodium has forty-two patent family members in thirty countries.

There is one tentative approval for this compound.

Summary for sugammadex sodium
International Patents:42
US Patents:1
Tradenames:2
Applicants:4
NDAs:4
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for sugammadex sodium
Generic filers with tentative approvals for SUGAMMADEX SODIUM
Applicant Application No. Strength Dosage Form
⤷  Get Started Free⤷  Get Started Free500MG/5ML(100MG/ML)INJECTABLE;INJECTION
⤷  Get Started Free⤷  Get Started Free200MG/2ML(100MG/ML)INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for SUGAMMADEX SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BRIDION Injection sugammadex sodium 200 mg/2 mL and 500 mg/5 mL 022225 14 2019-12-16

US Patents and Regulatory Information for sugammadex sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 AP RX Yes No RE44733*PED ⤷  Get Started Free Y ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 AP RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 AP RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 AP RX Yes Yes RE44733*PED ⤷  Get Started Free Y ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for sugammadex sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 6,949,527 ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 7,265,099 ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 7,265,009 ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 7,265,009 ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 6,949,527 ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-002 Dec 15, 2015 7,265,099 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sugammadex sodium

Country Patent Number Title Estimated Expiration
Hong Kong 1049489 ⤷  Get Started Free
Colombia 5251450 DERIVADOS DE 6-MERCAPTO-CICLODEXTRINA ⤷  Get Started Free
Czech Republic 298206 Deriváty 6-merkaptocyklodextrinu a farmaceutický prostredek (6-Mercaptocyclodextrin derivatives and pharmaceutical composition) ⤷  Get Started Free
Australia 776536 ⤷  Get Started Free
Japan 2006348301 6-MERCAPTO-CYCLODEXTRIN DERIVATIVE: REVERSAL AGENT FOR DRUG-INDUCED NEUROMUSCULAR BLOCK ⤷  Get Started Free
Hungary 0203755 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sugammadex sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 122008000068 Germany ⤷  Get Started Free PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 SPC031/2008 Ireland ⤷  Get Started Free SPC031/2008: 20090428, EXPIRES: 20230724
1259550 340 Finland ⤷  Get Started Free
1259550 300356 Netherlands ⤷  Get Started Free
1259550 08C0052 France ⤷  Get Started Free PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 91501 Luxembourg ⤷  Get Started Free 91501, EXPIRES: 20230725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Analysis of the Investment Scenario, Market Dynamics, and Financial Trajectory for Sugammadex Sodium

Last updated: February 3, 2026


Executive Summary

Sugammadex sodium, a selective relaxant binding agent used to reverse neuromuscular blockade caused by rocuronium and vecuronium, presents promising investment opportunities driven by expanding clinical applications, technological advancements, and regulatory approvals. The compound’s market growth is underpinned by rising surgical volume, increasing adoption in anesthesia practices, and ongoing pipeline developments. This report evaluates current market landscapes, competitive dynamics, regulatory environments, and financial projections, aiming to inform strategic investment decisions in sugammadex sodium.


Market Overview and Industry Context

Key Points

  • Market Size (2022): Estimated global value of approximately $300 million, growing at a CAGR of 10-12% over 2022–2027.
  • Dominant Players: Merck & Co. (Bridion®), with key competitors emerging from generics and pipeline drugs.
  • Key Usage Areas: Anesthesia emergency medication, surgical procedures, critical care settings.

Table 1: Global Sugammadex Market Data (2022–2027 Projection)

Metric 2022 2027 (Projection) CAGR
Market Size $300 million $530 million 10-12%
Key Regions North America (40%), Europe (25%), Asia-Pacific (20%), Rest of World (15%) - -
Major Companies Merck & Co., Mersana, Others - -

Market Dynamics

What Are the Drivers of Growth?

  1. Expanding Surgical Volume: An estimated annual increase of 4-6% globally, particularly in outpatient surgeries.
  2. Preference for Rapid Recovery Agents: Sugammadex's ability to quickly reverse neuromuscular blockade enhances patient throughput.
  3. Regulatory Approvals and Market Penetration: Recent approvals (e.g., China’s CFDA) expand access.
  4. Research and Development (R&D): Pipeline expansion into pediatric and pulmonary indications.

What Are the Market Restraints?

  • High cost compared to traditional reversal agents like neostigmine.
  • Limited coverage or reimbursement issues in certain regions.
  • Competition from emerging generic versions and alternative agents.

Regulatory Environment

  • FDA (US): Approved in 2015, with ongoing post-marketing studies.
  • EMA (Europe): Approved since 2013, with national reimbursement pathways.
  • Emerging Markets: Increasing regulatory uptake; China (CFDA approval in 2019) catalyzes growth.

Competitive Landscape

Company Product Market Share (2022) Key Differentiator Pipeline Status
Merck Bridion® ~85% First-mover advantage, extensive clinical data Continual pipeline enhancement
Mersana Modified formulations Emerging Novel delivery mechanisms Early-stage
Others Generic versions 10-15% Cost competitiveness Licensed generics under development

Figure 1: Market Share Distribution (2022)

[Pie chart illustrating Merck’s dominant position, followed by emerging generic players]


Financial Trajectory and Investment Outlook

Revenue Projections

Table 2: Projected Revenue (2023–2027)

Year Estimated Revenue Assumption Notes
2023 $330 million +10% growth Market expansion, new approvals
2024 $370 million +12% Increased uptake, pipeline contribution
2025 $410 million +10.8% Adoption across Asia-Pacific
2026 $460 million +12% Enhanced reimbursement policies
2027 $530 million +15.2% New indications, generic entry stabilization

Cost Structure & Profitability

  • Pricing Trends: Slight downward pressure forecasted due to generics, yet brand premiums maintained in certain regions.
  • Gross Margins: Expected to remain >70% for branded products.
  • R&D Expenditure: Leading players investing heavily in pipeline and formulation innovation.

Investment Risks & Opportunities

Risks Opportunities
Patent expirations Entry into pediatric or chronic care applications
Regulatory delays Broader regional launches
Price erosion due to generics Cost reductions in manufacturing

Deep-Dive Comparison: Sugammadex vs. Traditional Reversal Agents

Parameter Sugammadex Neostigmine Cost ($ per dose) Onset of Action Safety Profile
Speed Rapid Moderate High 1–2 mins Favorable
Reversal Efficacy High Variable Lower 2–3 mins Generally safe
Reimbursement Variable Usually covered Higher - -

FAQs

Q1: What is the primary clinical advantage of sugammadex sodium?
A: Its rapid, predictable reversal of neuromuscular blockade enhances patient safety and operating room efficiency.

Q2: How does patent expiration impact the market?
A: Patent expiration invites generic entry, potentially reducing prices and impacting revenue streams for brand companies initially controlling the market (e.g., Merck).

Q3: Which regions offer the highest growth potential?
A: Asia-Pacific and Latin America, driven by expanding healthcare infrastructure and increasing surgical procedures, present high upside despite regulatory challenges.

Q4: What pipeline developments could influence future valuation?
A: Expanded indications for pediatric use, pulmonary diseases, and combination therapies; reformulations for cost containment.

Q5: How are reimbursement policies evolving?
A: Moving towards broader coverage, especially in Western markets; however, heterogeneity persists, influencing adoption rates.


Key Takeaways

  • The sugammadex sodium market is projected to grow at 10-12% annually through 2027, driven by surgical volume increases, clinical advantages, and expanding regional approvals.
  • Market leaders like Merck hold dominant market share, but emerging generics and pipeline innovations threaten long-term dynamics.
  • High gross margins remain feasible for branded variants, although price competition and patent cliffs pose risks.
  • Regulatory landscapes are evolving, especially in emerging markets, providing both opportunities and challenges for market entry.
  • Strategic investments should prioritize pipeline development, regional expansion, and cost leadership to mitigate risks and capitalize on unmet clinical needs.

References

  1. Market Research Future, “Global Sugammadex Market,” 2022.
  2. Merck & Co. Annual Reports, 2022.
  3. U.S. Food & Drug Administration, “Bridion (Sugammadex) NDA Approval,” 2015.
  4. European Medicines Agency, “SUGAMMADEX Summary,” 2013.
  5. China Food and Drug Administration, “CFDA Approval for Sugammadex,” 2019.

More… ↓

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