BRIDION Drug Patent Profile

When do Bridion patents expire, and when can generic versions of Bridion launch?

Bridion is a drug marketed by Msd Sub Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in BRIDION is sugammadex sodium. There is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the sugammadex sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bridion

A generic version of BRIDION was approved as sugammadex sodium by ASPIRO on June 9^th, 2023.

Summary for BRIDION

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	67
Patent Applications:	53
Drug Prices:	Drug price information for BRIDION
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIDION
What excipients (inactive ingredients) are in BRIDION?	BRIDION excipients list
DailyMed Link:	BRIDION at DailyMed

See drug prices for BRIDION

Recent Clinical Trials for BRIDION

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

Sponsor	Phase
Tamas Vegh, MD	PHASE4
Korea University Ansan Hospital	Phase 4
Seoul National University Hospital	N/A

See all BRIDION clinical trials

Pharmacology for BRIDION

Paragraph IV (Patent) Challenges for BRIDION

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 BRIDION

BRIDION is protected by one US patents and two FDA Regulatory Exclusivities.

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	Yes					Y
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	AP	RX	Yes	Yes					Y
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	Yes
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	Yes
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	022225-001	Dec 15, 2015	AP	RX	Yes	Yes

Expired US Patents for BRIDION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015

International Patents for BRIDION

See the table below for patents covering BRIDION around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	026605	UN DERIVADO DE 6-MERCAPTO-CICLODEXTRINA, SU USO, UNA COMPOSICION FARMACEUTICA QUE LO COMPRENDE, UN KIT PARA PROPORCIONAR BLOQUEO NEUROMUSCULAR Y SUREVERSION, Y UN METODO PARA LA REVERSION DEL BLOQUEO NEUROMUSCULAR INDUCIDO POR FARMACOS
Austria	288450
Australia	5438001
Australia	776536
Brazil	0015947
Canada	2390463	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)
China	1188428

Supplementary Protection Certificates for BRIDION

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	91501	Luxembourg		91501, EXPIRES: 20230725
1259550	CA 2009 00002	Denmark		PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
1259550	300356	Netherlands
1259550	SPC031/2008	Ireland		SPC031/2008: 20090428, EXPIRES: 20230724
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	C01259550/01	Switzerland		FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
1259550	SPC/GB08/057	United Kingdom		PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725

BRIDION (sugammadex) Market Dynamics and Financial Trajectory: Exclusivity, Price Pressure, Competition, and Revenue Outlook

Last updated: July 23, 2026

BRIDION (sugammadex) remains a premium neuromuscular blockade reversal franchise with pricing and volume driven by anesthesia conversion economics, formulary access, and competitive displacement versus neostigmine-glycopyrrolate. Financial trajectory in the near term depends on (i) patent and exclusivity overhang versus generic and biosimilar substitutes, (ii) uptake in OR settings that value rapid, predictable reversal, and (iii) reimbursement dynamics and procurement tightening tied to global cost-containment cycles.

What patents protect BRIDION (sugammadex) and how do they shape pricing power and generic risk?

Core IP theme: composition and method claims around sugammadex for reversal of neuromuscular blockade (NMBA), including perioperative use. The practical effect is that IP strength governs when lower-cost competition can enter at scale, which in turn affects net price and gross-to-net erosion.

How many patent families cover sugammadex reversal and what claim types matter most?

Patent estates typically include:

• Composition of matter for sugammadex as the active ingredient.
• Formulation patents (concentration, excipients, presentation) tied to injectables.
• Method-of-use patents covering anesthesia induction/maintenance reversal timing and patient populations.
• Manufacturing/process patents influencing ability to launch a cost-competitive generic.

Business linkage: formulation and method-of-use barriers can delay market substitution even if basic composition protection is close to expiring, which slows the timing of meaningful price competition.

When does BRIDION lose exclusivity?

The financial inflection point for any branded injectable is when exclusivity ends and “first credible entrants” can price below benchmark. For sugammadex, market dynamics are dominated by:

• Patent expiration timing by jurisdiction
• Regulatory exclusivity and Orange Book listing status (US)
• Foreign-market pipeline and parallel import/labeling differences
• Paragraph IV or equivalent challenge outcomes where applicable

What generic entry risks exist for BRIDION in the US and EU?

Generic risk is usually front-loaded through:

• Regulatory approval pathways for a small-molecule injectable (ANDA-style for US unless an alternative pathway applies in a given jurisdiction).
• Label carve-outs if method claims remain contested.
• Launch delays if patent litigation leads to settlement-triggered entry dates.

Financial implication: even when approval is granted, time-to-market can be stretched by launch sequencing, supply readiness, and payer contracting.

What is the Orange Book status of BRIDION (sugammadex) and how does it affect Paragraph IV challenges?

Orange Book linkage: For a US prescription pharmaceutical, Orange Book listings determine which patents are “Orange Book listed” and thus eligible to support Paragraph IV litigation.

How do Orange Book listings influence generic launch timelines?

If BRIDION is listed with multiple patents (drug substance, formulation, and method-of-use), a generic manufacturer must:

• Either wait out listed patents,
• Or file a Paragraph IV certification for one or more patents,
• Or negotiate a settlement that sets a future entry date.

Business linkage: more listed patents, especially method-of-use or formulation patents with tight claim scope, increase the likelihood of staggered litigation and settlements, extending the branded revenue window.

What patent litigation affects BRIDION and what settlement patterns drive market entry delays?

For branded injectables, litigation often produces:

• Permanent injunction threats leading to settlement.
• Covenants not to sue that permit delayed entry on agreed dates.
• Design-around efforts for formulation/process claims.

Financial effect: litigation outcomes control when discounted offers become available through national wholesalers, GPO contracts, and hospital formularies.

BRIDION vs neostigmine: how does competition impact net price, volume, and margin?

Market structure: Sugammadex competes primarily against:

• Neostigmine-based reversal regimens (often paired with anticholinergics such as glycopyrrolate).
• Institutional protocols that prioritize cost minimization over reversal speed in lower-risk cases.

Why OR conversion is the main driver of sugammadex volume

Volume gains depend on whether hospitals change perioperative protocols to:

• Reduce residual neuromuscular blockade risk (a clinical driver),
• Improve OR throughput (an operational driver),
• Lower downstream costs from PACU interventions or pulmonary complications (an economic driver).

Economic translation: net revenue is a function of case volume multiplied by net price, which is highly sensitive to procurement cycles and payer reimbursement tightening.

Where price pressure typically comes from

Net price can erode through:

• Hospital group purchasing organization (GPO) contracting after competitor adoption.
• National distributor incentives and volume rebates.
• Therapeutic interchange by pharmacy and anesthesiology committees once generic or alternative branded options enter.

Which companies compete against BRIDION and how do their offerings shift market share?

Competition usually plays out along three axes:

1. Cost position (generic sugammadex or lower-cost alternatives)
2. Formulary access (tender awards, formulary listings)
3. Supply reliability (backorder risk affects formulary decisions)

How biosimilar or biologic competition is relevant (or not)

Sugammadex is a small-molecule active ingredient, so “biosimilar” frameworks generally do not apply. The competitive threat is primarily:

• Generic sugammadex products,
• Alternative NMBA reversal strategies (neostigmine-based protocols).

What formulations are protected by BRIDION and do they create operational/IP barriers?

Dosage form and presentation issues that can protect revenue

Injectable brands can remain protected by:

• Specific concentration and vial sizes used in hospital procurement,
• Formulation excipient blends controlling stability and manufacturability,
• Manufacturing processes that are harder to replicate at scale quickly.

Financial linkage: even if a generic enters on label, restricted presentations or supply constraints can delay broader substitution.

What drives BRIDION financial trajectory: sales mix, seasonality, and hospital contracting?

BRIDION’s commercial trajectory is influenced by:

• Procedure volume trends in elective and non-elective surgeries,
• Anesthesia practice patterns (conversion rate from neostigmine-based protocols),
• Hospital reimbursement conditions and budget constraints.

Quarterly P&L sensitivity

Branded injectable revenue typically reflects:

• Gross-to-net pressures through rebates and discounts,
• Wholesale buying patterns that can create lumpiness,
• Contract renewal cycles that reset net pricing.

How do reimbursement and procurement dynamics affect BRIDION revenue growth vs decline?

Net price mechanics in institutional markets

Hospital net pricing is shaped by:

• Contracted pricing through GPO or IDNs (integrated delivery networks),
• Pharmacy benefit manager (PBM) dynamics in US outpatient settings (less dominant for anesthesia injectables but still relevant where covered),
• Tender systems in EU markets.

Financial implication: even if list prices hold, net realization can fall rapidly after competitive contracting.

What is the regulatory status of BRIDION (sugammadex) and how does it affect market expansion and risk?

Sugammadex is an established, regulated reversal agent. Regulatory status affects:

• Label scope and whether replacement products can market the same indication at launch,
• Variation by country in dosing rules and eligible patient categories.

Business linkage: label breadth affects both adoption (clinician comfort) and payers’ willingness to cover.

When do generic or low-cost substitutes become commercially credible, and what does that do to BRIDION revenue?

Key market timing concept: commercial credibility typically requires more than approval. It requires:

• Stable supply,
• Hospital formulary acceptance,
• Tender and contract re-bids,
• Clinician confidence in product performance.

Financial inflection pattern:

• Early post-approval period shows limited volume due to contracting inertia.
• The biggest revenue declines often coincide with IDN-level protocol changes and multi-hospital tender awards.

BRIDION market outlook: what is the revenue exposure to pricing pressure and entry timing?

Revenue exposure framework (practical):

• High exposure if multiple listed patents expire or are successfully designed around, enabling rapid generic substitution.
• Medium exposure if litigation and settlements delay entry or restrict label/presentation.
• Lower exposure if the branded product remains entrenched in high-usage centers with conversion-driven protocol adoption.

Key Takeaways

• BRIDION’s financial trajectory depends on the interaction between IP-driven exclusivity timelines and institutional adoption economics in perioperative anesthesia reversal.
• Revenue growth is primarily a function of case volume conversion and net price management under hospital contracting cycles.
• The largest downside risk is timed generic substitution, not just regulatory approval, because formulary and procurement changes lag initial entrants.
• Formulation and method-of-use claims can extend branded leverage by slowing credible, scalable substitution across hospitals.

FAQs

1. What evidence most influences hospital formularies when choosing BRIDION vs neostigmine reversal?
2. How do GPO and IDN contracting cycles typically change net price for BRIDION after a new low-cost entrant?
3. What bottlenecks delay generic sugammadex market penetration after approval (supply, label, tender timing)?
4. What endpoint differences between reversal strategies drive payer and compliance narratives for anesthesia drugs?
5. How do changes in elective surgery volumes affect BRIDION seasonal revenue patterns?

References (APA)

1. Sources needed for a patent- and Orange-Book-driven financial trajectory were not provided in the prompt.