QUELICIN Drug Patent Profile

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Which patents cover Quelicin, and what generic alternatives are available?

Quelicin is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in QUELICIN is succinylcholine chloride. There is one drug master file entry for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the succinylcholine chloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Quelicin

A generic version of QUELICIN was approved as succinylcholine chloride by ZYDUS PHARMS on May 4^th, 2018.

Summary for QUELICIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Patent Applications:	3,267
Drug Prices:	Drug price information for QUELICIN
What excipients (inactive ingredients) are in QUELICIN?	QUELICIN excipients list
DailyMed Link:	QUELICIN at DailyMed

See drug prices for QUELICIN

Pharmacology for QUELICIN

Drug Class	Depolarizing Neuromuscular Blocker
Physiological Effect	Neuromuscular Depolarizing Blockade

US Patents and Regulatory Information for QUELICIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	QUELICIN	succinylcholine chloride	INJECTABLE;INJECTION	008845-006	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Hospira	QUELICIN PRESERVATIVE FREE	succinylcholine chloride	INJECTABLE;INJECTION	008845-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hospira	QUELICIN PRESERVATIVE FREE	succinylcholine chloride	INJECTABLE;INJECTION	008845-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hospira	QUELICIN PRESERVATIVE FREE	succinylcholine chloride	INJECTABLE;INJECTION	008845-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

QUELICIN Market Dynamics, Financial Trajectory, Patent Position, and Generic Competition

Last updated: October 23, 2026

QUELICIN is a legacy injectable formulation of succinylcholine chloride used for rapid skeletal-muscle paralysis during anesthesia and tracheal intubation. Its commercial profile is defined by mature clinical use, low patent protection, hospital procurement, supply reliability, and competition from other succinylcholine injections rather than by brand pricing power. Standalone QUELICIN revenue is not publicly disclosed, so its financial trajectory cannot be quantified from public-company reporting.

What is QUELICIN and how is it used?

QUELICIN contains succinylcholine chloride, a short-acting depolarizing neuromuscular blocker. It is administered intravenously or intramuscularly as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal-muscle relaxation during surgery or mechanical ventilation procedures.[1]

Attribute	QUELICIN profile
Active ingredient	Succinylcholine chloride
Drug class	Depolarizing neuromuscular blocker
Dosage form	Injectable solution
Primary setting	Hospitals, operating rooms, emergency departments
Main use	Rapid sequence intubation and short-duration paralysis
Regulatory pathway	Legacy FDA-approved injectable product
Prescription status	Prescription-only
Commercial category	Mature hospital generic/legacy injectable
Principal substitutes	Other succinylcholine injections and nondepolarizing neuromuscular blockers

The drug has a rapid onset and short duration of action. Its clinical utility remains strongest where rapid airway control is required and where clinicians want a brief neuromuscular block.

What is the FDA regulatory status of QUELICIN?

QUELICIN is an FDA-approved prescription injection. Public labeling identifies the product as succinylcholine chloride injection and includes boxed warnings concerning cardiac arrest, malignant hyperthermia, anaphylaxis, hyperkalemia, and other serious risks.[1]

The product is associated with legacy FDA approval rather than recent new-drug development. Its commercial value is therefore tied to manufacturing authorization, supply continuity, institutional contracts, and inclusion in hospital formularies.

The FDA label identifies important contraindications, including:

• Known susceptibility to malignant hyperthermia
• Skeletal-muscle myopathies
• Major burns or severe trauma after the acute phase
• Known hypersensitivity
• Situations associated with severe hyperkalemia risk
• Certain neuromuscular disorders

These restrictions narrow the addressable market relative to some nondepolarizing neuromuscular blockers, but they do not eliminate demand because succinylcholine remains an established emergency-intubation option.

What patents protect QUELICIN?

No commercially meaningful, active patent estate is apparent for QUELICIN’s basic succinylcholine chloride injection product. Succinylcholine is an old active pharmaceutical ingredient, and the core composition and clinical-use concepts are long past ordinary U.S. patent terms.

IP category	Current commercial relevance
Succinylcholine active ingredient	No meaningful exclusivity remaining
Basic injectable composition	Generally expired or no longer commercially blocking
Method of rapid intubation	Unlikely to provide enforceable brand exclusivity
Container or packaging	Potentially relevant only if separately patented
Manufacturing process	May be confidential know-how, but not a visible market barrier
Trademark	QUELICIN brand protection may remain distinct from drug exclusivity

The principal barriers are operational. Injectable manufacturing requires validated sterile production, quality systems, regulatory compliance, and reliable access to active ingredient and components. These barriers can support a limited supplier base even when patent protection is absent.

When does QUELICIN lose exclusivity?

QUELICIN has already lost practical market exclusivity. The drug is a mature injectable and competes in a generic-like procurement environment.

FDA exclusivity for a legacy product is not the principal commercial issue. Any remaining brand recognition does not create the pricing power associated with a recently approved product. Hospitals generally evaluate succinylcholine injections through formulary review, group purchasing organization contracts, availability, dose presentation, and acquisition price.

There is no credible basis to identify a future “loss of exclusivity” event comparable to the patent cliff for a modern small-molecule brand. The relevant commercial question is whether additional approved suppliers enter or existing suppliers withdraw.

How many patents cover QUELICIN?

The number of patents that materially block a competing succinylcholine chloride injection appears to be zero or effectively zero. Public patent databases may contain historical patents involving neuromuscular blockers, formulations, containers, or manufacturing methods, but historical filings do not necessarily create current freedom-to-operate risk.

A competitor would still need to address:

1. FDA approval of its product.
2. Sterile injectable manufacturing requirements.
3. Chemistry, manufacturing, and controls documentation.
4. Drug-supply chain qualification.
5. Hospital contracting and distribution.
6. Pharmacovigilance and postmarket quality obligations.

These requirements can delay entry without creating patent exclusivity.

What is the Orange Book status of QUELICIN?

The Orange Book is relevant for identifying listed patents and regulatory exclusivity associated with approved drug products. For a legacy succinylcholine injection such as QUELICIN, the commercial expectation is no active, high-value patent listing that would prevent competing suppliers from obtaining approval.[2]

The practical Orange Book conclusion is:

Orange Book issue	QUELICIN assessment
Active ingredient patent	No meaningful remaining protection expected
Drug-product patent	No commercially significant blocking position identified
Method-of-use listing	No material barrier apparent
New chemical entity exclusivity	Expired
Paragraph IV exposure	Low strategic significance
Generic entry risk	Already realized

The absence of a strong Orange Book estate means litigation is unlikely to be the central determinant of market share.

Are there Paragraph IV challenges to QUELICIN?

Paragraph IV litigation is not a major current risk category for QUELICIN. Paragraph IV challenges are most consequential when a branded product has active Orange Book patents and substantial revenue at stake. QUELICIN is a mature injectable with no apparent patent-based exclusivity position that would support a significant patent challenge campaign.

Potential entrants would more likely pursue an abbreviated approval route or another applicable FDA pathway without triggering high-value patent litigation. The principal risks would involve regulatory deficiencies, manufacturing capacity, product quality, and commercial contracting.

What formulations are protected by QUELICIN patents?

No major formulation patent position is apparent for the standard succinylcholine chloride injection. The product’s differentiation is not based on an extended-release system, device platform, complex delivery technology, or biologic formulation.

Relevant technical attributes include:

• Sterile injectable presentation
• Succinylcholine chloride concentration
• Preservative and excipient profile
• Container-closure system
• Storage and stability controls
• Compatibility with hospital administration practices

These attributes can create approval and manufacturing work, but they do not appear to support durable brand exclusivity.

What companies compete with QUELICIN?

Competition comes from two groups: suppliers of succinylcholine injection and manufacturers of alternative neuromuscular blockers.

Direct competitors

Direct competitors may include products marketed under other manufacturers’ names or generic labels, including suppliers associated with Pfizer/Hospira and other injectable-drug manufacturers. Product availability varies by national market, presentation, supplier status, and shortage conditions.

Therapeutic alternatives

Clinicians can substitute nondepolarizing neuromuscular blockers such as rocuronium or vecuronium. These products do not have identical pharmacology, onset, duration, or reversal profiles. Substitution therefore depends on the clinical context and hospital protocol.

Competitive factor	QUELICIN	Rocuronium-type alternatives
Mechanism	Depolarizing	Nondepolarizing
Onset	Rapid	Rapid at appropriate dose
Duration	Short	Generally longer
Reversal	Not routinely reversed in the same manner	Can be reversed with specific agents
Hyperkalemia concern	Material	Lower in many settings
Malignant hyperthermia relevance	Important contraindication	Different risk profile
Procurement role	Low-cost legacy injectable	Often higher-value hospital injectable

The competitive threat is therefore broader than generic succinylcholine. Hospitals may retain QUELICIN for selected emergency and anesthetic uses while using rocuronium or related agents for other procedures.

What drives QUELICIN market demand?

Demand is relatively stable but narrow. Key drivers include:

• Volume of surgical procedures
• Emergency department and intensive-care intubations
• Emergency medical services protocols
• Hospital anesthesia policies
• Availability and price of alternative neuromuscular blockers
• National and regional drug shortages
• Clinician preference and training
• Group purchasing organization contracts

Demand is not primarily driven by consumer advertising or chronic-disease prevalence. It is institutional and procedure-based.

The product is exposed to changes in hospital procedure volumes. Elective-surgery disruptions can reduce demand, while emergency intubation activity and critical-care utilization can support volume. Because the drug is administered in acute-care settings, stock availability can matter more than nominal list price.

How strong is the QUELICIN patent estate?

The patent estate is weak from a defensive commercial perspective because the active ingredient and standard injectable concept are mature. The product’s defensibility comes from execution rather than intellectual property.

Defensibility category	Assessment
Composition-of-matter patent	None of practical value
Formulation patent	Weak or not apparent
Method-of-use patent	Weak or not apparent
Trademark	Limited brand differentiation
Manufacturing know-how	Moderate operational value
Sterile capacity	Potentially significant
Hospital contracts	Commercially relevant
Regulatory history	Useful but not exclusive

Sterile injectable capacity is the main structural barrier. A supplier can have a legally open market but still fail to achieve commercial entry because of plant qualification, fill-finish capacity, quality findings, or inability to secure predictable active-ingredient supply.

What patent litigation affects QUELICIN?

No major current patent litigation is apparent as a central factor in QUELICIN’s commercial outlook. The product’s age and lack of meaningful patent exclusivity reduce the economic rationale for litigation.

Potential disputes would more likely concern:

• Product liability
• Manufacturing quality
• Labeling
• Supply agreements
• Procurement contracts
• Regulatory compliance
• Shortage allocation

These issues are distinct from Orange Book patent litigation and may affect supply or reputation without changing the legal exclusivity position.

What is the financial trajectory of QUELICIN?

Standalone QUELICIN revenue is not publicly reported. The product appears to be part of a broader injectable or hospital-products portfolio rather than a separately disclosed commercial franchise.

Its likely financial trajectory has four characteristics:

1. Low or moderate unit pricing relative to innovative drugs.
2. Stable but limited procedure-linked demand.
3. Margin sensitivity to sterile-manufacturing costs.
4. Periodic price and volume volatility during shortages.

Financial variable	Expected QUELICIN impact
Patent expiry	Already reflected in the market
Volume growth	Low, linked to procedures and intubation
Price growth	Possible during constrained supply, difficult to sustain
Gross margin	Sensitive to fill-finish, quality, and logistics costs
Revenue concentration	Likely concentrated in hospital and distributor channels
Forecast visibility	Moderate in normal supply conditions
Upside potential	Limited without supply disruption or portfolio expansion
Downside risk	Supplier exit, shortage, quality event, or substitution

For a manufacturer, QUELICIN can have strategic value despite limited revenue because hospital customers often purchase several injectable products from the same supplier. The product may support portfolio breadth, contract retention, and distribution economics.

What generic launch scenarios exist for QUELICIN?

The most likely scenarios are market-share shifts rather than a single generic cliff.

Scenario 1: Stable multi-supplier market

Several suppliers maintain adequate inventory. Prices remain competitive, and QUELICIN retains a share based on formulary familiarity and contract position.

Scenario 2: Supplier withdrawal

One manufacturer exits because of low margins, quality costs, or plant constraints. Remaining suppliers gain volume and may raise prices. Hospitals increase inventory buffers and qualify alternatives.

Scenario 3: Shortage-driven substitution

A supply interruption shifts use toward other succinylcholine presentations or rocuronium. Some share may return after supply normalizes, but hospital protocols can change permanently.

Scenario 4: New low-cost entrant

A new approved supplier enters with reliable sterile capacity and aggressive contracting. QUELICIN loses share unless its manufacturer offers price, availability, or portfolio advantages.

What manufacturing and IP barriers affect QUELICIN?

Manufacturing barriers are more important than patent barriers. Injectable suppliers must demonstrate consistent sterility, potency, stability, container integrity, and process control. FDA inspection findings or remediation can disrupt supply even when demand remains strong.[3]

Supply risk may arise from:

• Limited sterile fill-finish lines
• Active-ingredient shortages
• Component shortages
• Batch failures
• Manufacturing-site remediation
• Distribution allocation
• Low return on production capacity

These factors make QUELICIN vulnerable to episodic shortages. Hospital buyers may prioritize suppliers with redundant manufacturing and dependable allocation over suppliers offering the lowest nominal price.

How does QUELICIN compare with other neuromuscular blockers?

QUELICIN has a distinct clinical role rather than a broad therapeutic monopoly.

Drug category	Main advantage	Main limitation
Succinylcholine, including QUELICIN	Rapid onset and short duration	Hyperkalemia and malignant-hyperthermia concerns
Rocuronium	Broad use and reversal options	Longer duration and higher acquisition cost in some settings
Vecuronium	Established nondepolarizing option	Slower onset and different dosing requirements
Cisatracurium	Useful in selected critical-care settings	Less suited to rapid emergency paralysis

The commercial market is shaped by clinical substitution. A shortage of QUELICIN can produce immediate demand for alternatives, but alternative products may not be interchangeable in every protocol.

What is the geographic coverage of QUELICIN?

The strongest commercial relevance is in the United States, where the product is associated with FDA-approved hospital use and U.S. procurement channels. International availability depends on local registrations, distributors, and national formularies. A U.S. FDA approval does not establish global market authorization.

Geographic revenue exposure is likely concentrated in:

• U.S. acute-care hospitals
• Academic medical centers
• Ambulatory surgery facilities
• Emergency departments
• Critical-care institutions
• Government and institutional procurement systems

Key Takeaways

• QUELICIN is a mature succinylcholine chloride injection used primarily in hospitals.
• Its active ingredient, core formulation, and principal clinical uses have no meaningful remaining patent exclusivity.
• The Orange Book and Paragraph IV landscape are commercially secondary because the market is already genericized.
• Standalone revenue is not publicly disclosed.
• Financial performance depends on hospital procedure volumes, contracts, manufacturing costs, and supply continuity.
• Sterile manufacturing capacity and quality compliance are more important than patents.
• Rocuronium and other nondepolarizing neuromuscular blockers are important therapeutic and commercial substitutes.
• The main upside comes from supply constraints or portfolio synergies, not from price-protected innovation.
• The main downside risks are supplier withdrawal, manufacturing disruption, shortage-driven substitution, and hospital contract loss.

FAQs

Is QUELICIN a generic drug?

QUELICIN is a branded product containing the mature generic active ingredient succinylcholine chloride. Its market behaves like a hospital generic rather than a protected innovative drug.

Does QUELICIN have biosimilar competition?

No. Biosimilars apply to biological products. QUELICIN is a small-molecule injectable and competes with generic injectable products, not biosimilars.

Can hospitals substitute rocuronium for QUELICIN?

Hospitals can use rocuronium as a clinical alternative in appropriate cases, but the drugs have different pharmacology, duration, contraindications, protocols, and reversal considerations. Substitution requires clinical judgment and institutional policy.

Is QUELICIN vulnerable to a drug shortage?

Yes. Sterile injectable products can experience shortages because production depends on specialized facilities, validated processes, quality release, and limited fill-finish capacity. The commercial impact can be material even when the underlying drug has no patent protection.

Does QUELICIN generate material revenue for its manufacturer?

Public disclosures do not identify standalone QUELICIN revenue. Its value is more likely tied to portfolio participation, hospital contracts, and dependable supply than to a large independent revenue stream.

References

1. U.S. Food and Drug Administration. (2024). QUELICIN (succinylcholine chloride) injection, prescribing information.
2. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2025). Drug shortages and product availability database.