BRETYLIUM TOSYLATE - Generic Drug Details

What are the generic sources for bretylium tosylate and what is the scope of patent protection?

Bretylium tosylate is the generic ingredient in four branded drugs marketed by Abraxis Pharm, Astrazeneca, Breckenridge, Hikma, Hospira, Intl Medication, Luitpold, Abbott, B Braun, Baxter Hlthcare, and Hospira Inc, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

Summary for BRETYLIUM TOSYLATE

US Patents:	0
Tradenames:	4
Applicants:	11
NDAs:	17
Drug Master File Entries:	3
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,388
What excipients (inactive ingredients) are in BRETYLIUM TOSYLATE?	BRETYLIUM TOSYLATE excipients list
DailyMed Link:	BRETYLIUM TOSYLATE at DailyMed

Medical Subject Heading (MeSH) Categories for BRETYLIUM TOSYLATE

Adrenergic Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

US Patents and Regulatory Information for BRETYLIUM TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	BRETYLOL	bretylium tosylate	INJECTABLE;INJECTION	017954-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hospira	BRETYLIUM TOSYLATE	bretylium tosylate	INJECTABLE;INJECTION	019030-001	Apr 29, 1986		DISCN	Yes	No
Astrazeneca	BRETYLIUM TOSYLATE	bretylium tosylate	INJECTABLE;INJECTION	071152-001	Aug 10, 1987		DISCN	No	No
Luitpold	BRETYLIUM TOSYLATE	bretylium tosylate	INJECTABLE;INJECTION	070891-001	Jul 26, 1988		DISCN	No	No
Hikma	BRETYLIUM TOSYLATE	bretylium tosylate	INJECTABLE;INJECTION	070545-001	May 14, 1986		DISCN	No	No
Abbott	BRETYLIUM TOSYLATE IN DEXTROSE 5%	bretylium tosylate	INJECTABLE;INJECTION	019005-003	Apr 29, 1986		DISCN	No	No
Abbott	BRETYLIUM TOSYLATE IN DEXTROSE 5%	bretylium tosylate	INJECTABLE;INJECTION	019005-001	Apr 29, 1986		DISCN	No	No

Expired US Patents for BRETYLIUM TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hospira	BRETYLOL	bretylium tosylate	INJECTABLE;INJECTION	017954-001	Approved Prior to Jan 1, 1982	RE29618

Last updated: September 8, 2026

ecutive summary: Bretylium tosylate is a legacy injectable antiarrhythmic with minimal current commercial scale, no meaningful branded franchise, and limited patent protection. Its economic profile is driven by hospital emergency inventories, intermittent shortages, regulatory reactivation, and generic manufacturing economics rather than routine prescription demand. Amiodarone, lidocaine, and defibrillation have displaced bretylium in most advanced cardiac-life-support protocols. Public company filings do not separately report bretylium revenue, so the product cannot be valued as a material standalone commercial asset.

Bretylium Tosylate Market Dynamics, Patent Status, FDA History, and Financial Outlook

What is the current market status of bretylium tosylate?

Bretylium tosylate is an injectable antiarrhythmic historically used for life-threatening ventricular fibrillation and ventricular tachycardia. Its commercial market is now narrow and institutionally concentrated.

The product has several characteristics associated with low-value, low-volume generic medicines:

• It is administered in emergency and intensive-care settings.
• Demand is episodic rather than chronic.
• Hospitals must maintain emergency inventories even when utilization is low.
• Substitution by amiodarone, lidocaine, cardioversion, and defibrillation reduces routine demand.
• Manufacturing interruptions can create disproportionate market disruption.
• Public financial disclosures do not identify bretylium revenue as a material business line.

Bretylium is therefore best classified as a legacy emergency injectable, not as a growth pharmaceutical asset.

Market factor	Effect on bretylium tosylate
Therapeutic use	Narrow emergency antiarrhythmic indication
Dosage form	Sterile injectable
Demand pattern	Low volume, intermittent, hospital-based
Main alternatives	Amiodarone, lidocaine, electrical cardioversion, defibrillation
Commercial model	Generic or specialty injectable procurement
Pricing power	Limited outside shortage periods
Patent protection	Historical protection expired; no modern branded estate of consequence
Revenue visibility	Low; not separately disclosed by major public companies
Market outlook	Stable niche demand with weak long-term growth

What FDA indications and regulatory status apply to bretylium tosylate?

FDA labeling identifies bretylium tosylate injection for the prompt control of life-threatening ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia, when other therapies are ineffective or unsuitable. The drug is administered intravenously or intramuscularly under hospital supervision because of hypotension and other cardiovascular risks (U.S. Food and Drug Administration, n.d.-a).

Bretylium is a quaternary ammonium compound that initially releases norepinephrine and later inhibits sympathetic neurotransmission. Its pharmacology can produce marked hypotension, which limits use in unstable patients.

The FDA regulatory history is more complex than that of a continuously marketed branded drug. Historic approval and labeling records exist, but commercial availability has changed repeatedly. FDA sources have identified bretylium products as discontinued or unavailable at different times, and current commercial availability can depend on a specific manufacturer, National Drug Code, and supply status.

What is the FDA regulatory status of bretylium tosylate?

Bretylium does not have the profile of a newly marketed FDA product with active exclusivity. Current regulatory relevance is tied to approved injectable products, manufacturing status, and shortage reporting.

The FDA’s Drugs@FDA and Drug Shortages databases are the primary sources for determining whether a particular bretylium product is approved, marketed, discontinued, or subject to supply constraints. A product’s presence in an FDA database does not necessarily mean that it is continuously available from wholesalers.

When does bretylium tosylate lose exclusivity?

Bretylium’s meaningful exclusivity expired decades ago. The molecule and its original clinical use date to the mid-20th century. Any composition-of-matter, formulation, or early method-of-use patents would have expired long before the modern generic-drug market.

No commercially significant active patent estate is associated with the core bretylium tosylate molecule. The principal competitive barriers are manufacturing, sterile-facility qualification, regulatory compliance, procurement access, and inventory economics.

What patents protect bretylium tosylate?

No material, unexpired U.S. patent protection is generally associated with the active ingredient bretylium tosylate. The original molecule is too old to support current patent exclusivity.

Potentially relevant intellectual-property categories would include:

IP category	Current commercial relevance
Active ingredient patent	Expired
Original therapeutic-use patent	Expired
Injectable formulation patent	No known commercially important active estate
Device patent	Not central to the product
Manufacturing process patent	Possible in theory, but unlikely to block ordinary generic manufacture
Regulatory exclusivity	No current new-drug exclusivity of commercial significance

A company seeking to launch bretylium would compete primarily through an abbreviated new drug application, an approved legacy product pathway, or another applicable FDA route. Patent litigation is not the principal entry risk.

What is the Orange Book status of bretylium tosylate?

Bretylium’s Orange Book relevance is limited. The Orange Book records approved drug products and patent information, but an old injectable may appear under a discontinued, historical, or manufacturer-specific record rather than as an active commercial reference product.

There is no apparent modern Orange Book patent barrier comparable to those associated with protected branded cardiovascular drugs. A prospective generic entrant would need to evaluate:

• Whether an approved reference product remains available.
• Whether the relevant product is listed as discontinued.
• Whether FDA considers the discontinuation temporary or permanent.
• Whether any listed patent or exclusivity code remains operative.
• Whether a new drug application or alternative approval route is required.

A Paragraph IV challenge would have little strategic value unless an active patent were listed against a currently marketed reference product. The age of bretylium makes that scenario unlikely.

How many patents cover bretylium tosylate?

The commercially relevant number is effectively zero for active core-drug protection. Historical patent documents may exist, but they do not create present-day market exclusivity.

Patent-count analysis should distinguish between:

1. Historical documents covering the molecule or early use.
2. Expired patents that remain visible in databases.
3. Active U.S. patents listed for an approved product.
4. Secondary patents that could restrict a particular formulation or manufacturing process.

For bretylium, the first category is likely to dominate. Patent density is therefore a poor indicator of competitive risk.

What is the commercial and competitive landscape for bretylium tosylate?

Bretylium competes against clinical alternatives rather than against a large branded peer group.

Alternative	Competitive position
Amiodarone injection	Common hospital antiarrhythmic for refractory ventricular arrhythmias
Lidocaine injection	Established alternative for ventricular arrhythmias
Electrical defibrillation	First-line intervention in relevant cardiac-arrest settings
Synchronized cardioversion	Used for selected unstable tachyarrhythmias
Procainamide	Used in selected tachyarrhythmia settings
Bretylium tosylate	Rescue or historical option with limited availability

The American Heart Association’s modern advanced cardiovascular life-support guidance does not position bretylium as a routine first-line therapy. Protocols emphasize high-quality CPR, defibrillation where indicated, epinephrine, amiodarone, and lidocaine in relevant circumstances (American Heart Association, 2020).

This clinical displacement has reduced recurring demand. Bretylium remains commercially relevant when a hospital wants a backup agent, when alternative drugs are unavailable, or when a protocol retains the product for selected refractory cases.

What formulations are protected by bretylium tosylate patents?

The commercial product is an injectable solution, historically supplied at a concentration of 50 milligrams per milliliter. The formulation is simple compared with modern liposomal, depot, transdermal, or device-enabled products.

The main technical barriers are not formulation patents. They are:

• Sterility assurance.
• Container-closure integrity.
• Stability and particulate control.
• Raw-material qualification.
• Validation of aseptic filling.
• Low-volume production economics.
• Compliance with current good manufacturing practice requirements.

A manufacturer may still develop proprietary process controls or packaging improvements, but those measures generally do not create durable market exclusivity for the molecule.

What manufacturing and supply-chain barriers affect bretylium?

Bretylium is exposed to the same structural risks that affect other low-volume sterile injectables. A manufacturer must operate or contract with a qualified sterile facility, maintain validated production capacity, and justify continued manufacturing despite uncertain demand.

The supply chain has four important characteristics:

1. Low annual unit demand can make production runs economically inefficient.
2. Hospitals may increase purchases sharply when an alternative drug is in shortage.
3. A single facility interruption can affect most of the available market.
4. Wholesaler inventories may not reflect reliable long-term supply.

These conditions create a market in which availability can matter more than nominal list price. A manufacturer may obtain temporary pricing leverage during a shortage, but that leverage is difficult to sustain after competing supply returns.

What is the financial trajectory for bretylium tosylate?

The financial trajectory is mature, volatile, and structurally limited.

Historical phase

Bretylium originated as an older cardiovascular therapy and entered a market with few effective alternatives for severe ventricular arrhythmias. Its early value came from clinical utility in high-risk emergency care.

Generic displacement phase

Amiodarone, lidocaine, improved resuscitation protocols, and electrical therapies reduced bretylium use. Generic economics then replaced branded pricing with hospital-contract pricing and purchasing-group negotiations.

Availability and shortage phase

Commercial interruptions increased the product’s strategic value to hospitals but did not create durable market expansion. Shortage-driven sales are typically episodic. They may increase realized price per vial while reducing confidence in long-term supply.

Current phase

Bretylium is a niche hospital product with limited organic growth. Financial performance depends on whether a supplier can:

• Maintain FDA-compliant sterile production.
• Secure hospital and group-purchasing contracts.
• Avoid prolonged inventory expiration.
• Price the product above its manufacturing and compliance costs.
• Supply the market during competitor shortages.
• Keep the product in emergency formularies.

No reliable public revenue series is available for bretylium as a standalone product. Large manufacturers do not normally disclose sales for an old generic injectable with immaterial contribution to consolidated revenue.

Which companies are challenging bretylium tosylate?

The competitive challenge is primarily therapeutic and commercial, not patent-based.

Companies marketing amiodarone, lidocaine, and other injectable antiarrhythmics compete for the same hospital emergency budgets. Generic injectable manufacturers can also enter if they obtain the relevant FDA approval and establish sterile manufacturing capacity.

There is no prominent current Paragraph IV litigation campaign directed at bretylium comparable to patent disputes involving blockbuster cardiovascular products. Litigation exposure is more likely to arise from product quality, supply contracts, manufacturing compliance, or labeling issues than from patent infringement.

What generic launch scenarios exist for bretylium tosylate?

A new entrant would face three possible commercial outcomes.

Launch scenario	Likely result
Routine dual-source supply	Low margins and limited volume
Competitor shortage	Temporary volume and pricing increase
Sole-source or near-sole-source supply	Stronger procurement position but high supply obligations
Broad protocol adoption	Unlikely without new clinical evidence or guideline change
Reimbursement-driven expansion	Limited because use is emergency and inpatient

The most attractive scenario is a shortage-supported launch into a market with established hospital demand. The least attractive scenario is routine supply competition without shortage conditions, because annual volume may not support substantial commercial infrastructure.

What patent litigation and settlement agreements affect bretylium?

No major active patent litigation or settlement agreement is central to bretylium’s current market position. The lack of an active patent estate removes the principal basis for delayed generic entry, authorized-generic settlements, or launch-at-risk disputes.

A diligence review should focus instead on:

• FDA approval status.
• Discontinued-product classification.
• Current shortage records.
• Manufacturer inspection history.
• Product recalls.
• Hospital-contract terms.
• Exclusivity under procurement arrangements.

How strong is the patent estate for bretylium tosylate?

The patent estate is weak because the underlying molecule and indication are old, the dosage form is conventional, and no important modern delivery technology supports the product.

Patent-strength criterion	Assessment
Core molecule	Very weak; historical protection expired
Method of use	Weak; established indication
Formulation	Weak; conventional injectable
Manufacturing process	Potentially relevant but unlikely to block entry
Regulatory exclusivity	No significant current protection
Litigation leverage	Low
Freedom to operate	Generally favorable, subject to product-specific review

Bretylium’s defensibility is operational rather than legal. A reliable sterile supply, regulatory history, and hospital procurement position may be more valuable than patents.

How does bretylium compare with amiodarone?

Factor	Bretylium tosylate	Amiodarone
Clinical role	Rescue or legacy option	Established hospital and outpatient antiarrhythmic
Demand	Low and episodic	Broad, recurring demand
Dosage forms	Primarily injectable	Injectable and oral
Patent value	No meaningful current estate	Historical estate, generally expired or weakened
Generic competition	Limited but possible	Extensive
Revenue potential	Niche	Material therapeutic-market revenue
Supply sensitivity	High	Moderate to high depending on presentation
Growth outlook	Flat to declining	Larger and more durable market

Amiodarone has a substantially stronger commercial position because it has oral maintenance use, broader prescribing, and greater inclusion in hospital protocols. Bretylium’s value is tied to backup availability rather than market share growth.

What is the outlook for bretylium tosylate revenue?

Revenue is likely to remain small relative to mainstream cardiovascular drugs. The product can generate attractive margins for a supplier with low incremental production costs and limited competition, but total market revenue is constrained by:

• Low patient volume.
• Narrow clinical use.
• Declining guideline relevance.
• Generic price pressure.
• Product expiration risk.
• High sterile-manufacturing costs.
• Lack of prescription or chronic-use demand.

The most credible financial thesis is a small specialty-generic opportunity with shortage upside, not a scalable pharmaceutical franchise.

Key takeaways

• Bretylium tosylate is a legacy emergency injectable antiarrhythmic.
• Its active pharmaceutical ingredient and historical uses are far beyond normal patent-life periods.
• No material modern Orange Book patent estate or Paragraph IV litigation strategy is apparent.
• Amiodarone, lidocaine, defibrillation, and cardioversion have reduced demand.
• Commercial value depends on hospital preparedness, supply reliability, and shortage conditions.
• Public companies do not separately disclose meaningful bretylium revenue.
• The product has limited growth potential and weak legal defensibility.
• Manufacturing capability, FDA compliance, and procurement access are the primary barriers to entry.
• The financial profile is niche, volatile, and unsuitable for a blockbuster-drug valuation framework.

FAQs about bretylium tosylate market value and exclusivity

Is bretylium tosylate still sold in the United States?

Availability has changed over time and must be assessed at the manufacturer and product-code level. FDA approval records do not guarantee continuous commercial distribution.

Does bretylium tosylate have generic competition?

Its age and lack of meaningful patent protection permit generic competition in principle. Actual competition is constrained by low demand and sterile-injectable manufacturing economics.

Can a company obtain a Paragraph IV settlement for bretylium?

A Paragraph IV strategy would require a listed patent against an applicable reference product. Bretylium’s old chemistry makes a commercially significant Paragraph IV dispute unlikely.

Is bretylium tosylate included in current ACLS protocols?

Modern advanced cardiovascular life-support protocols emphasize defibrillation, epinephrine, amiodarone, and lidocaine in relevant settings. Bretylium is not a routine first-line ACLS therapy (American Heart Association, 2020).

Is bretylium tosylate commercially attractive for a specialty-generic manufacturer?

It can be attractive as a limited niche product if the manufacturer has qualified sterile capacity and can secure procurement contracts. Its total revenue ceiling is low, and returns depend heavily on supply interruptions affecting competing products.

References

1. American Heart Association. (2020). 2020 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation, 142(Suppl. 2).

2. U.S. Food and Drug Administration. (n.d.-a). Bretylium tosylate injection prescribing information. FDA.

3. U.S. Food and Drug Administration. (n.d.-b). Drugs@FDA: FDA-approved drugs database. FDA.

4. U.S. Food and Drug Administration. (n.d.-c). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

5. U.S. Food and Drug Administration. (n.d.-d). Drug shortages database. FDA.

6. DailyMed. (n.d.). Bretylium tosylate injection drug labeling. National Library of Medicine.