MIVACRON Drug Patent Profile

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

Mivacron is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in MIVACRON is mivacurium chloride. There are two drug master file entries for this compound. Additional details are available on the mivacurium chloride profile page.

Summary for MIVACRON

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	5
Patent Applications:	634
Drug Prices:	Drug price information for MIVACRON
DailyMed Link:	MIVACRON at DailyMed

See drug prices for MIVACRON

Recent Clinical Trials for MIVACRON

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

Sponsor	Phase
Université Libre de Bruxelles	N/A
University Hospital Ostrava	N/A
Tang-Du Hospital	Phase 2

See all MIVACRON clinical trials

US Patents and Regulatory Information for MIVACRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	MIVACRON	mivacurium chloride	SOLUTION;INTRAVENOUS	020098-001	Jan 22, 1992		DISCN	Yes	No
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-002	Jan 22, 1992		DISCN	No	No
Abbvie	MIVACRON	mivacurium chloride	SOLUTION;INTRAVENOUS	020098-004	Jan 22, 1992		DISCN	Yes	No
Abbvie	MIVACRON	mivacurium chloride	SOLUTION;INTRAVENOUS	020098-005	Jan 22, 1992		DISCN	Yes	No
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-003	Jan 22, 1992		DISCN	No	No

Expired US Patents for MIVACRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	MIVACRON	mivacurium chloride	SOLUTION;INTRAVENOUS	020098-001	Jan 22, 1992

International Patents for MIVACRON

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

Country	Patent Number	Title	Estimated Expiration
Germany	3581699
Ireland	58138	Bis-dimethoxymethyl(trimethoxybenzyl)isoquinolinium salts, their preparation and pharmaceutical compositions containing them
Finland	85019
Luxembourg	88801
South Africa	8505407
Ireland	851791
Singapore	3493

Supplementary Protection Certificates for MIVACRON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0181055	SPC/GB93/031	United Kingdom		SPC/GB93/031:, EXPIRES: 20071207
0181055	96C0001	Belgium		PRODUCT NAME: MIVACURIUM CHLORID.= MIVACURIUM (+5% OVERDOSERING); NAT REG.: 251 IS 152 F 12 19951114; FIRST REG.: GB 0003/0325 19921208

MIVACRON Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for MIVACRON

Introduction

MIVACRON, a neuromuscular blocking agent, is used in conjunction with anesthetic medicines to relax muscles during surgery. Understanding its market dynamics and financial trajectory involves examining its clinical use, market competition, and the broader pharmaceutical industry context.

Clinical Use and Pharmacology

MIVACRON (mivacurium chloride) is a benzylisoquinolinium compound with a clinical duration of action that is twice that of succinylcholine but one-half to one-third that of intermediate-acting agents like atracurium and vecuronium[5].

• Dosage and Administration: The ED95 (dose required to produce 95% suppression of the adductor pollicis muscle twitch response) for adults is 0.07-0.08 mg/kg. The drug is administered intravenously, and its onset time is about 2-3 minutes at twice the ED95[5].
• Pharmacokinetics: MIVACRON is metabolized by plasma cholinesterase, and its pharmacokinetics are dose-proportional. It does not exhibit phase II block or tachyphylaxis when used as a continuous infusion[5].

Market Competition

The neuromuscular blocking agent market is competitive, with several drugs available.

• Competitors: Other neuromuscular blockers like atracurium, vecuronium, and succinylcholine compete with MIVACRON. Each has its own pharmacological profile, which influences their market share and usage[5].
• Generic Competition: Once a drug's patent expires, generic versions can enter the market, significantly reducing prices and altering market dynamics. However, generic drug prices remain above long-run marginal costs until there are 8 or more competitors[3].

Financial Trajectory

The financial performance of MIVACRON is influenced by several factors, including its clinical utility, market competition, and regulatory environment.

• Revenue Generation: MIVACRON generates revenue primarily through its use in surgical procedures. Its short duration of action and ease of use make it a preferred choice in certain clinical settings[4].
• Cost Structure: The cost of producing MIVACRON includes manufacturing, distribution, and marketing expenses. The drug is supplied by Aspen Pharmacare Australia Pty Ltd in Australia, among other regions[4].

Impact of Regulatory and Market Factors

Regulatory changes and market dynamics can significantly impact the financial trajectory of a drug.

• Regulatory Approval and Compliance: MIVACRON must comply with regulatory standards set by health authorities such as the FDA. Any changes in regulatory requirements can affect its market availability and pricing[1].
• Market Withdrawals: Although MIVACRON has not been withdrawn from the market, the impact of drug withdrawals on companies can be significant. For example, the withdrawal of Vioxx by Merck led to a substantial loss in market capitalization and legal liabilities[2].

Pricing and Reimbursement

The pricing of MIVACRON is influenced by its clinical value, competition, and reimbursement policies.

• Pricing Strategy: The price of MIVACRON is set based on its clinical benefits, production costs, and market competition. Volatile anesthetics can decrease the dosing requirement and prolong the duration of action, which may affect pricing strategies[1].
• Reimbursement: Reimbursement policies by healthcare providers and insurance companies play a crucial role in the drug's financial performance. Changes in reimbursement policies can impact the drug's market share and revenue[3].

Hemodynamic and Safety Considerations

The safety profile of MIVACRON also affects its market dynamics.

• Hemodynamic Effects: MIVACRON can cause transient decreases in mean arterial blood pressure (MAP) and increases in heart rate (HR), particularly when administered rapidly or in high doses. These effects are usually minimal and resolve quickly[1].
• Histamine Release: Like atracurium, MIVACRON can cause histamine release, leading to hypotension. This side effect must be managed carefully to maintain patient safety and confidence in the drug[5].

Patient and Clinical Factors

The drug's performance is also influenced by patient demographics and clinical conditions.

• Pediatric and Elderly Patients: MIVACRON has different pharmacodynamic profiles in children and elderly patients. Children have a faster onset and shorter duration of action, while elderly patients have a duration comparable to younger adults[5].
• Special Populations: Patients with atypical plasma cholinesterase activity or those undergoing organ transplants may experience prolonged blockade, which requires careful management[5].

Manufacturer and Distribution

The financial trajectory of MIVACRON is also tied to its manufacturer and distribution network.

• Manufacturer: Aspen Pharmacare Australia Pty Ltd is the supplier of MIVACRON in Australia. The company's financial health and distribution capabilities are crucial for the drug's market presence[4].

Key Takeaways

• Clinical Utility: MIVACRON's short duration of action and ease of use make it a valuable option in surgical settings.
• Market Competition: The drug competes with other neuromuscular blockers, and its market share is influenced by generic competition and pricing strategies.
• Regulatory and Safety Factors: Compliance with regulatory standards and management of side effects are critical for maintaining market presence.
• Financial Performance: Revenue generation, cost structure, and reimbursement policies all impact the financial trajectory of MIVACRON.

FAQs

Q: What is the primary use of MIVACRON in clinical settings? A: MIVACRON is used together with anesthetic medicines to relax the body's muscles during surgery.

Q: How does MIVACRON compare to other neuromuscular blocking agents? A: MIVACRON has a shorter duration of action compared to intermediate-acting agents like atracurium and vecuronium but longer than ultra-short-acting agents like succinylcholine.

Q: What are the potential side effects of MIVACRON? A: MIVACRON can cause transient decreases in mean arterial blood pressure and increases in heart rate, as well as histamine release leading to hypotension.

Q: How does the administration rate of MIVACRON affect its hemodynamic effects? A: Administering MIVACRON over 30 to 60 seconds can minimize decreases in mean arterial blood pressure and other hemodynamic effects.

Q: What is the impact of generic competition on the pricing of MIVACRON? A: Generic competition can significantly reduce prices, but prices remain above long-run marginal costs until there are 8 or more competitors in the market.

Cited Sources

1. MIVACRON® Injection (mivacurium chloride) - accessdata.fda.gov
2. A study of prescription drug withdrawals - GETD
3. Generic Drug Industry Dynamics - Federal Trade Commission
4. Mivacron - NPS MedicineWise
5. Clinical pharmacology of mivacurium chloride: a review - PubMed