MIVACURIUM CHLORIDE - Generic Drug Details

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What are the generic drug sources for mivacurium chloride and what is the scope of patent protection?

Mivacurium chloride is the generic ingredient in three branded drugs marketed by Abbvie, Rising, and Woodward, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for MIVACURIUM CHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	3
Patent Applications:	957
DailyMed Link:	MIVACURIUM CHLORIDE at DailyMed

Recent Clinical Trials for MIVACURIUM CHLORIDE

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

Sponsor	Phase
Peng Liang	NA
Tang-Du Hospital	Phase 2
Jiangsu Nhwa Pharmaceutical Co., Ltd.	Phase 2

See all MIVACURIUM CHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MIVACURIUM CHLORIDE

M03AC	Other quaternary ammonium compounds
M03A	MUSCLE RELAXANTS, PERIPHERALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

US Patents and Regulatory Information for MIVACURIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Woodward	MIVACURIUM CHLORIDE	mivacurium chloride	SOLUTION;INTRAVENOUS	209708-001	Oct 12, 2021		DISCN	No	No
Rising	MIVACURIUM CHLORIDE	mivacurium chloride	INJECTABLE;INJECTION	078562-001	Apr 30, 2009		DISCN	No	No
Abbvie	MIVACRON	mivacurium chloride	SOLUTION;INTRAVENOUS	020098-004	Jan 22, 1992		DISCN	Yes	No
Woodward	MIVACURIUM CHLORIDE	mivacurium chloride	SOLUTION;INTRAVENOUS	209708-002	Oct 12, 2021		DISCN	No	No

Expired US Patents for MIVACURIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-002	Jan 22, 1992
Abbvie	MIVACRON	mivacurium chloride	SOLUTION;INTRAVENOUS	020098-001	Jan 22, 1992

Mivacurium Chloride Market Dynamics, Patent Position, and Financial Trajectory

Last updated: September 4, 2026

Mivacurium chloride is a mature, short-acting neuromuscular blocking agent used as an adjunct to general anesthesia and for facilitating tracheal intubation. Its commercial profile is defined by generic competition, hospital purchasing pressure, limited public revenue disclosure, and low strategic value relative to newer or more widely used paralytics. The original U.S. brand, Mivacron, no longer drives the market. Public sources do not report standalone global sales for mivacurium chloride, so its financial trajectory must be assessed through regulatory status, supplier availability, hospital demand, and generic-market economics.

What is mivacurium chloride used for?

Mivacurium chloride is an intravenous, short-duration, nondepolarizing neuromuscular blocker. It produces skeletal-muscle paralysis by competitively inhibiting acetylcholine at the neuromuscular junction. The FDA label identifies use as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal-muscle relaxation during surgery or mechanical ventilation [1].

Its pharmacology differentiates it from longer-acting agents such as pancuronium and intermediate-duration products such as rocuronium and vecuronium. Mivacurium is hydrolyzed primarily by plasma cholinesterase, allowing relatively rapid recovery in patients with normal enzyme activity. Recovery can be prolonged in patients with atypical or deficient plasma cholinesterase activity [1].

What dosage forms and strengths are marketed?

Mivacurium chloride is supplied as a sterile injectable solution for intravenous administration. Historical U.S. labeling identified single-dose vials containing 10 mg/10 mL and 20 mg/20 mL, equivalent to 1 mg/mL [1]. The commercial product is administered in hospitals, operating rooms, intensive-care units, and emergency settings rather than through retail pharmacies.

The injectable presentation creates manufacturing and distribution requirements that are more demanding than those for ordinary solid-dose generics. Suppliers must maintain sterile production, validated filling operations, container-closure integrity, stability data, and controlled distribution. Those requirements can reduce the number of active suppliers even when the underlying molecule has no meaningful patent barrier.

How large is the mivacurium chloride market?

No authoritative public source reports global or U.S. sales for mivacurium chloride as a standalone product. IQVIA, supplier disclosures, and hospital-contract data are generally not publicly available at the molecule level. The addressable market is best characterized as a small hospital injectable segment within the broader neuromuscular-blocking-agent market.

Demand is structurally limited by several factors:

• Mivacurium is used almost exclusively in institutional care.
• The product competes with established alternatives, especially succinylcholine, rocuronium, and vecuronium.
• It is not a chronic-use medicine.
• Each surgical procedure consumes a limited quantity.
• Anesthesia departments frequently standardize on a small number of paralytics.
• Hospital formularies prioritize supply reliability and contract pricing.

Mivacurium can retain clinical demand where rapid offset, short duration, or specific anesthesiology protocols are valued. Those advantages do not automatically translate into strong pricing because procurement decisions are typically made through group purchasing organizations, hospital systems, and competitive tenders.

How does mivacurium compare with competing neuromuscular blockers?

Product	Clinical duration	Main commercial position	Principal competitive pressure
Mivacurium chloride	Short	Short-acting nondepolarizing blocker	Lower use frequency and limited supplier base
Succinylcholine	Very short	Rapid intubation and emergency use	Low cost and established emergency role
Rocuronium bromide	Intermediate	Routine intubation and surgical relaxation	Broad use and sugammadex reversal
Vecuronium bromide	Intermediate	Surgical relaxation and critical care	Familiarity and generic availability
Cisatracurium besylate	Intermediate	Operating room and intensive-care use	Organ-independent metabolism and established protocols

Rocuronium has the strongest broad-market position among modern nondepolarizing alternatives because of its wide use, availability in multiple generic presentations, and compatibility with sugammadex reversal. Succinylcholine remains important for rapid-sequence intubation despite its adverse-effect profile. Mivacurium’s commercial opportunity is therefore concentrated in selected clinical protocols rather than general market expansion.

What is the FDA regulatory status of mivacurium chloride?

Mivacurium chloride was approved in the United States under the Mivacron brand. The original FDA labeling identifies Burroughs Wellcome Co. as the sponsor of Mivacron and describes the drug’s anesthesia indications and dosing requirements [1].

The product has since moved into a mature generic or legacy-product phase. FDA labeling and historical drug databases identify mivacurium chloride injection as an approved prescription injectable, but commercial availability has been inconsistent. A product can remain approved while being listed as discontinued, unavailable from a particular manufacturer, or absent from routine hospital purchasing channels.

What is the Orange Book status of mivacurium chloride?

The FDA Orange Book is the relevant source for approved drug applications, therapeutic-equivalence evaluations, patent listings, and exclusivity information [2]. For a mature injectable such as mivacurium chloride, Orange Book analysis should distinguish among:

1. The original brand NDA.
2. Any approved abbreviated new drug applications.
3. Current marketing status.
4. Listed patents and associated expiration dates.
5. Therapeutic-equivalence codes for generic products.

Publicly available sources do not indicate a commercially significant, unexpired U.S. patent estate controlling mivacurium chloride injection. The market is therefore governed primarily by manufacturing capability, supply continuity, regulatory compliance, and purchasing contracts rather than by branded patent exclusivity.

What patents protect mivacurium chloride?

The original compound and early formulation rights are old and are not expected to provide current U.S. market exclusivity. Mivacurium was developed decades ago, and the commercial product entered the market in the early 1990s. Any ordinary composition-of-matter or original formulation patents would have expired under the applicable pre- and post-1995 U.S. patent-term rules.

No current, high-value patent family is publicly associated with a new mivacurium chloride formulation, delivery system, or use that would materially block generic competition in the United States. The practical IP position is therefore weak compared with recently launched drugs.

Are there formulation patents for mivacurium chloride?

Mivacurium chloride injection is a conventional sterile parenteral product. Potential patentable features could include:

• Stabilized aqueous formulations.
• Container-closure systems.
• Concentration or dilution methods.
• Compatibility with infusion devices.
• Manufacturing processes that improve stability or sterility.

No publicly prominent formulation patent appears to create a current market barrier for standard mivacurium chloride injection. Any process patent would need to be evaluated claim by claim and would not necessarily prevent an ANDA applicant from using a non-infringing manufacturing route.

Are there method-of-use patents for mivacurium chloride?

The core uses of mivacurium chloride, including neuromuscular blockade during general anesthesia and tracheal intubation, are longstanding labeled uses. They are unlikely to support enforceable, commercially meaningful exclusivity today. A narrow method-of-use patent could theoretically cover a specific patient population, dosing regimen, or combination, but no such publicly prominent U.S. patent is known to drive the current market.

When did mivacurium chloride lose exclusivity?

Mivacurium chloride lost practical branded exclusivity years ago. The original product was approved in 1992, and any ordinary regulatory exclusivity associated with the initial approval has long expired. The commercial question is no longer when generic entry begins. It is whether a manufacturer can profitably maintain supply in a low-volume sterile-injectable market.

Unlike a newly approved drug, mivacurium does not have a meaningful remaining period of new chemical entity exclusivity, pediatric exclusivity, or market exclusivity. Patent expiry and regulatory exclusivity are not the principal constraints on present competition.

Have companies filed Paragraph IV challenges?

No publicly prominent, current Paragraph IV campaign is associated with mivacurium chloride. Paragraph IV litigation generally occurs when an ANDA applicant challenges an Orange Book-listed patent before generic launch. For a legacy injectable with no identified blocking patent estate, the commercial incentive to file such a challenge is limited.

Any historic patent certifications would need to be reviewed through the relevant Orange Book editions, ANDA records, and federal court dockets. They do not appear to define the current competitive structure.

What generic entry risks exist for mivacurium chloride?

The principal risk is supply-driven competition rather than patent-driven entry. A low-volume generic injectable can experience rapid market-share shifts when one supplier has a manufacturing interruption, quality event, or discontinued presentation.

The main risks are:

Risk	Market effect
Additional sterile-injectable suppliers	Price erosion and contract displacement
Manufacturing interruption	Shortages, emergency purchasing, and temporary price increases
Hospital formulary substitution	Loss of volume to rocuronium, succinylcholine, or cisatracurium
Product discontinuation	Reduced access and possible temporary supplier concentration
API or packaging constraints	Production delays and higher unit costs
GPO contracting	Lower net prices despite stable clinical demand

Generic entry would probably reduce pricing if a new supplier achieves reliable FDA-compliant production. The effect would be limited by the small total market, but incumbent suppliers could lose contracts quickly because hospitals often treat equivalent injectable products as procurement commodities.

Which companies are challenging the mivacurium chloride market?

Public information does not identify an active branded challenger with a distinct commercial strategy. Competition is more likely to come from generic injectable manufacturers and contract suppliers than from companies developing differentiated mivacurium products.

Potential market participants include manufacturers with established sterile-injectable platforms, hospital-focused generic portfolios, or contract manufacturing capacity. The relevant competitive variables are:

• FDA approval and inspection history.
• Ability to produce sterile vials at commercial scale.
• Availability of active pharmaceutical ingredient.
• Hospital and GPO contracting access.
• Shortage-management capability.
• Product continuity across multiple package sizes.

Brand identity has limited value in this market. A supplier with dependable delivery may outperform a lower-cost rival that cannot maintain inventory.

How strong is the patent estate for mivacurium chloride?

The patent estate is weak from a current commercial-protection perspective.

Patent factor	Assessment
Composition-of-matter protection	Expired or commercially irrelevant
Original formulation protection	Expired or commercially irrelevant
Method-of-use protection	No significant current barrier identified
New delivery-system protection	No prominent market-blocking estate identified
Orange Book patent leverage	Limited
Paragraph IV exposure	Low
Manufacturing know-how	More important than patent rights
Regulatory barrier	Moderate because the product is sterile injectable

The principal defensibility of a mivacurium product is operational. Validated sterile manufacturing, regulatory history, hospital contracts, and dependable supply can create practical barriers even when patent protection is absent.

What is the financial trajectory for mivacurium chloride?

Mivacurium chloride should be viewed as a low-growth, low-revenue, mature hospital generic rather than a growth pharmaceutical asset. Its financial trajectory is likely characterized by:

1. Long-term volume stability in selected anesthesia protocols.
2. Weak or declining nominal pricing under generic procurement.
3. Periodic price spikes during shortages.
4. Low product-level profitability unless manufacturing is efficient.
5. Limited investment in new clinical development.
6. Greater value as part of a hospital injectable portfolio than as a standalone asset.

Product-level revenue is not publicly disclosed by major pharmaceutical companies. The absence of reported sales prevents a reliable calculation of annual revenue, gross margin, or market share. Public-company filings generally aggregate hospital injectables or broader portfolios rather than isolate mivacurium chloride.

What could improve the product’s commercial value?

A supplier could improve economics through:

• Reliable availability during competitor shortages.
• Multi-product hospital contracting.
• Efficient vial and packaging operations.
• Regional distribution agreements.
• A differentiated concentration or presentation, if clinically and regulatorily justified.
• Inclusion in anesthesia-focused generic portfolios.

A standalone licensing deal for mivacurium is unlikely to command substantial value unless it includes manufacturing assets, regulatory approvals, hospital contracts, or a broader injectable portfolio.

What licensing deals affect mivacurium chloride?

No major publicly disclosed recent licensing transaction appears to center on mivacurium chloride. The product’s age, generic status, and limited revenue base reduce the likelihood of a material standalone licensing deal.

Commercial transfers are more likely to involve:

• ANDA ownership changes.
• Product acquisitions bundled with other injectables.
• Contract manufacturing arrangements.
• Regional distribution rights.
• Divestitures of hospital products.

These transactions may not disclose product-level consideration. The economic value generally comes from the broader portfolio and manufacturing platform rather than from mivacurium alone.

What manufacturing and geographic barriers affect the market?

The market is geographically fragmented. Regulatory approval, labeling, packaging, drug-shortage rules, and procurement practices differ by jurisdiction. A manufacturer with U.S. approval cannot automatically sell the product in Europe, Canada, Japan, or emerging markets without local authorization and supply arrangements.

The main manufacturing barriers are sterile-process validation, inspection readiness, batch-release controls, and supply-chain continuity. API sourcing is important but generally less defensible than finished-dose manufacturing capability. A supplier that controls a reliable sterile-injectable facility can maintain share despite limited patent protection.

Key Takeaways

• Mivacurium chloride is a mature short-acting neuromuscular blocker used mainly in hospital anesthesia.
• Its market is small, institutional, and price-sensitive.
• Public sources do not report standalone product revenue or reliable market-share data.
• The original Mivacron brand no longer provides meaningful commercial exclusivity.
• No significant current patent estate appears to block generic competition.
• Paragraph IV litigation is not a visible driver of the market.
• Sterile manufacturing, hospital contracts, and supply reliability matter more than patents.
• Rocuronium, succinylcholine, vecuronium, and cisatracurium provide substantial competitive pressure.
• Financial returns are likely modest unless mivacurium is bundled into a broader injectable portfolio.
• Shortages can temporarily increase prices and supplier leverage, but do not create durable exclusivity.

FAQs About Mivacurium Chloride Market and Patent Risk

Is mivacurium chloride still commercially available in the United States?

Availability has been inconsistent across manufacturers and time periods. Approval status, marketing status, and current inventory are separate issues and should be assessed through FDA databases and supplier listings.

Does mivacurium chloride have biosimilar competition?

No. Biosimilars apply to biologic products. Mivacurium chloride is a small-molecule chemical drug and competes through generic injectable applications rather than the biosimilar pathway.

Can a generic manufacturer launch mivacurium chloride without patent litigation?

Potentially, if no unexpired, enforceable Orange Book-listed patent blocks the launch and the applicant satisfies FDA approval requirements. The principal barriers are sterile manufacturing and commercial supply, not identified patent claims.

Is mivacurium chloride more profitable than rocuronium?

There is no public product-level financial data supporting a reliable margin comparison. Rocuronium has a broader clinical market, while mivacurium may benefit from niche demand and occasional supply constraints.

What would cause mivacurium chloride prices to rise?

The most likely causes are supplier withdrawal, sterile-manufacturing interruptions, API shortages, regulatory holds, or hospital demand shifts during periods of constrained supply. Patent expiry is not a likely cause because the product is already mature.

References

1. U.S. Food and Drug Administration. (1992). Mivacron (mivacurium chloride) injection prescribing information.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book