SUGAMMADEX SODIUM - Generic Drug Details

What are the generic 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, and Zydus Pharms, and is included in three 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 are two drug master file entries for sugammadex sodium. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for SUGAMMADEX SODIUM

International Patents:	42
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	10
Patent Applications:	89
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUGAMMADEX SODIUM
DailyMed Link:	SUGAMMADEX SODIUM at DailyMed

Recent Clinical Trials for SUGAMMADEX SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Korea University Ansan Hospital	Phase 4
YingHsuanTai	N/A
Zhejiang Cancer Hospital	N/A

See all SUGAMMADEX SODIUM clinical trials

Generic filers with tentative approvals for SUGAMMADEX SODIUM

Applicant	Application No.	Strength	Dosage Form
		500MG/5ML(100MG/ML)	INJECTABLE;INJECTION
		200MG/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.

Pharmacology for SUGAMMADEX SODIUM

Anatomical Therapeutic Chemical (ATC) Classes for SUGAMMADEX SODIUM

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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	022225-001	Dec 15, 2015	AP	RX	Yes	Yes
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No
Zydus Pharms	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214290-002	Oct 4, 2023		DISCN	No	No
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No	RE44733		Y	Y

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
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	7,265,009
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	6,949,527
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	7,265,099
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	7,265,009

International Patents for SUGAMMADEX SODIUM

Country	Patent Number	Title	Estimated Expiration
Czech Republic	298206	Deriváty 6-merkaptocyklodextrinu a farmaceutický prostredek (6-Mercaptocyclodextrin derivatives and pharmaceutical composition)
European Patent Office	1259550	DERIVES DE 6-MERCAPTO-CYCLODEXTRINE: AGENTS D'INVERSION DU BLOCAGE NEUROMUSCULAIRE PROVOQUE PAR DES SUBSTANCES MEDICAMENTEUSES (6-MERCAPTO-CYCLODEXTRIN DERIVATIVES: REVERSAL AGENTS FOR DRUG-INDUCED NEUROMUSCULAR BLOCK)
Germany	122008000068
Luxembourg	91501
Japan	4563972

Supplementary Protection Certificates for SUGAMMADEX SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	C01259550/01	Switzerland		FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
1259550	CA 2009 00002	Denmark		PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
1259550	300356	Netherlands
1259550	2008C/047	Belgium		PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550	SZ 47/2008	Austria		PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRÄGLICHES SALZ HIERVON

SUGAMMADEX SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sugammadex Sodium

Introduction to Sugammadex Sodium

Sugammadex sodium, marketed under the brand name Bridion, is a selective relaxant binding agent used for the reversal of moderate to deep neuromuscular blockade induced by rocuronium or vecuronium during surgery. This drug has revolutionized the field of anesthesia by providing a rapid and effective way to reverse neuromuscular blockade, enhancing patient safety and recovery times.

Market Size and Growth Projections

The global market for sugammadex sodium has been experiencing significant growth. As of 2023, the market size was valued at USD 1.53 billion and is projected to reach USD 2.89 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.5% from 2024 to 2031[4].

Key Drivers of Market Growth

Increasing Surgical Procedures

The rising number of surgical procedures worldwide is a major driver for the sugammadex sodium market. As the global population ages and healthcare infrastructure improves, the demand for surgical interventions increases, thereby boosting the need for neuromuscular blocking agents and their reversal agents like sugammadex sodium[4].

Patient Safety and Recovery

The emphasis on patient safety and quick recovery times in medical facilities is another significant factor. Sugammadex sodium's ability to rapidly reverse deep levels of neuromuscular blockade without significant adverse effects makes it a preferred choice, driving its adoption in hospitals and surgical centers[4].

Regulatory Approvals and Clinical Research

Continuing clinical research and regulatory approvals are expanding the therapeutic indications and optimizing dosing regimens for sugammadex sodium. This ongoing development is expected to further propel the market's growth in the near future[4].

Strict Safety Regulations

Strict safety laws requiring the use of reversal agents in anesthesia also contribute to the market's expansion. The necessity of ensuring patient safety during and after surgical procedures mandates the use of effective reversal agents like sugammadex sodium[4].

Market Segmentation

By Type

The market is primarily segmented by the type of product, which is sugammadex sodium injection. The purity levels of the drug, such as purity ≥99%, are also important considerations in market analysis[1][4].

By Application

Sugammadex sodium is predominantly used as a reversal agent for neuromuscular blockade during surgery. Its efficacy in reversing the effects of rocuronium or vecuronium makes it a critical component in surgical anesthesia[4][5].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its own market dynamics, influenced by local healthcare infrastructure, regulatory environments, and patient needs[4].

Key Companies and Market Competition

The sugammadex sodium market is dominated by several key players, including Merck & Co. Inc., Orion Corporation, Organon, Novartis AG, Pfizer Inc., and others. These companies play a crucial role in the development, marketing, and distribution of sugammadex sodium, influencing market competition and growth[4].

Financial Performance and Revenue Projections

The financial performance of the sugammadex sodium market is robust, with significant revenue growth anticipated over the forecast period. The market's valuation is expected to nearly double from 2023 to 2031, indicating strong financial prospects for companies involved in this sector[4].

Clinical and Regulatory Landscape

Approval History

Sugammadex sodium was approved by Health Canada in 2016 for the reversal of moderate to deep neuromuscular blockade induced by rocuronium or vecuronium. This approval was based on comprehensive quality, non-clinical, and clinical evaluations[5].

Safety and Efficacy

Clinical trials have demonstrated the safety and efficacy of sugammadex sodium. However, studies have also highlighted potential adverse effects, such as decreased fetal body weights and delayed ossification in animal studies, which are considered in the drug's labeling[2].

Market Challenges and Opportunities

Challenges

Despite its growth, the market faces challenges such as competition from other reversal agents like neostigmine methylsulfate. The market dynamics between different manufacturers, such as Avadel, Fresenius, and West-Ward, also impact the sales and revenue of sugammadex sodium[3].

Opportunities

The ongoing research and development aimed at expanding therapeutic indications and optimizing dosing regimens present significant opportunities for growth. Additionally, the acquisition of companies and partnerships within the pharmaceutical industry can enhance market presence and profitability[3][4].

Impact of Technological Innovation

Technological innovation and advancements in drug delivery platforms are expected to further enhance the performance of sugammadex sodium, making it more broadly used in downstream applications. This includes improvements in surgical techniques and healthcare infrastructure, which support the market's expansion[1][3].

Global Healthcare Market Context

The global pharmaceutical market, valued at $1.475 trillion in 2022, is growing at a CAGR of 5% over the next six years. This broader market trend supports the growth of niche markets like sugammadex sodium, as healthcare spending and technological advancements continue to rise[1].

Conclusion

The market for sugammadex sodium is poised for significant growth driven by increasing surgical procedures, emphasis on patient safety, and ongoing clinical research. With a projected CAGR of 8.5% from 2024 to 2031, this market offers substantial financial and growth opportunities for pharmaceutical companies.

Key Takeaways

• Market Size and Growth: The sugammadex sodium market was valued at USD 1.53 billion in 2023 and is expected to reach USD 2.89 billion by 2031.
• Key Drivers: Increasing surgical procedures, patient safety, and regulatory approvals are major drivers.
• Market Segmentation: Segmented by type, application, and geography.
• Key Companies: Merck & Co. Inc., Orion Corporation, Organon, and others.
• Financial Performance: Robust revenue growth anticipated over the forecast period.
• Clinical and Regulatory Landscape: Approved by Health Canada in 2016; ongoing research and development.

FAQs

Q1: What is sugammadex sodium used for?

Sugammadex sodium is used for the reversal of moderate to deep neuromuscular blockade induced by rocuronium or vecuronium during surgery.

Q2: What is the projected market size of sugammadex sodium by 2031?

The market size of sugammadex sodium is expected to reach USD 2.89 billion by 2031.

Q3: What are the key drivers of the sugammadex sodium market?

Key drivers include increasing surgical procedures, emphasis on patient safety, and ongoing clinical research and regulatory approvals.

Q4: Which companies are major players in the sugammadex sodium market?

Major players include Merck & Co. Inc., Orion Corporation, Organon, Novartis AG, and Pfizer Inc.

Q5: What are the potential challenges facing the sugammadex sodium market?

Challenges include competition from other reversal agents and market dynamics between different manufacturers.

Sources

1. Pharmaceutical Grade Sugammadex Sodium Market 2024: Trends, Growth Drivers, and Market Outlook - OpenPR
2. Bridion (sugammadex sodium) for reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium - FDA
3. AVADEL PHARMACEUTICALS PLC - Avadel Pharmaceuticals
4. Global Sugammadex Sodium Market Size and Projections - Market Research Intellect
5. Summary Basis of Decision for Bridion - Health Canada