CHLORZOXAZONE - Generic Drug Details

What are the generic sources for chlorzoxazone and what is the scope of freedom to operate?

Chlorzoxazone is the generic ingredient in four branded drugs marketed by Acme Labs, Actavis Elizabeth, Ajenat Pharms, Anda Repository, Appco, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Corepharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Novitium Pharma, Ohm Labs, Ph Health, Pioneer Pharms, Rising, Senores Pharms, Sun Pharm Industries, Teva Pharms Usa Inc, Watson Labs, Ortho Mcneil Pharm, Janssen R And D, and Ferndale Labs, and is included in thirty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for chlorzoxazone. Twenty suppliers are listed for this compound.

Summary for CHLORZOXAZONE

US Patents:	0
Tradenames:	4
Applicants:	23
NDAs:	38
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Patent Applications:	6,202
Drug Prices:	Drug price trends for CHLORZOXAZONE
What excipients (inactive ingredients) are in CHLORZOXAZONE?	CHLORZOXAZONE excipients list
DailyMed Link:	CHLORZOXAZONE at DailyMed

See drug prices for CHLORZOXAZONE

Recent Clinical Trials for CHLORZOXAZONE

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

Sponsor	Phase
University of Baghdad	PHASE4
University of Texas Southwestern Medical Center	Phase 1
Tufts University	Phase 1

See all CHLORZOXAZONE clinical trials

Pharmacology for CHLORZOXAZONE

Drug Class	Muscle Relaxant
Physiological Effect	Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for CHLORZOXAZONE

Muscle Relaxants, Central

Anatomical Therapeutic Chemical (ATC) Classes for CHLORZOXAZONE

M03BB	Oxazol, thiazine, and triazine derivatives
M03B	MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

US Patents and Regulatory Information for CHLORZOXAZONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corepharma	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	214941-002	Oct 20, 2022	AA	RX	No	No
Pioneer Pharms	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	089948-001	Jan 6, 1989		DISCN	No	No
Ohm Labs	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	081298-001	Dec 29, 1993		DISCN	No	No
Watson Labs	CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	081040-001	Aug 22, 1989		DISCN	No	No

Market Dynamics and Financial Trajectory for Chlorzoxazone

Last updated: July 29, 2025

---

Overview of Chlorzoxazone

Chlorzoxazone is a centrally acting muscle relaxant primarily used to alleviate muscle spasms and associated pain. Approved in numerous countries, including the United States and Europe, it is often prescribed for conditions such as back pain, musculoskeletal injuries, and neurological disorders. Despite its established presence, the drug operates in a complex pharmaceutical landscape influenced by evolving medical guidelines, generic competition, and emerging treatment alternatives.

Market Landscape and Competitive Environment

Therapeutic Positioning

Chlorzoxazone occupies a niche within the muscle relaxant segment, competing with agents like methocarbamol, carisoprodol, and cyclobenzaprine. Its unique mechanism involves the suppression of spinal cord reflexes, providing effective symptomatic relief. However, the drug's utilization is often influenced by prescriber preferences, regulatory approval status, and formulary inclusion.

Generic Penetration and Price Dynamics

Since patent protections have long expired in many jurisdictions, chlorzoxazone's market largely comprises generic formulations. The price erosion caused by generics significantly impacts revenue streams, compelling manufacturers to seek differentiation through formulations or distribution channels. Generic manufacturing reduces barriers to entry but also constrains profit margins.

Regulatory Considerations

Regulatory agencies such as the FDA and EMA maintain stringent approval pathways for new indications, combination therapies, or modified formulations. The safety profile of chlorzoxazone, notably the risk of hepatotoxicity, has influenced labeling and prescribing patterns. Regulatory scrutiny and adverse event reports may restrict use or necessitate post-marketing surveillance investments.

Market Drivers and Constraints

Increasing Prevalence of Musculoskeletal Disorders

The rising global burden of musculoskeletal conditions, propelled by aging populations and sedentary lifestyles, boosts demand for muscle relaxants, including chlorzoxazone. According to the Global Burden of Disease Study, musculoskeletal disorders account for a significant global disability burden, which directly underpins market growth projections.

Physician and Patient Preferences

Clinicians favor drugs with well-documented efficacy and safety. Chlorzoxazone’s long-standing profile, familiarity, and cost-effectiveness contribute to sustained prescriptions. Conversely, concerns over hepatotoxicity, especially with long-term or high-dose use, may limit its usage in certain clinical scenarios.

Emergence of New Therapeutics

The development and approval of newer agents—such as combination analgesic-muscle relaxant formulations, or biologics targeting underlying pathologies—pose competitive challenges. Additionally, non-pharmacologic interventions like physiotherapy gain prominence, potentially reducing reliance on muscle relaxants.

Financial Trajectory and Revenue Outlook

Market Revenue Trends

Accurate financial projections for chlorzoxazone demand consideration of global prescription volumes, pricing strategies, and manufacturing costs. The dominance of generics often results in modest per-unit margins but compensates with high volume sales. In mature markets, revenue stagnation is common, with growth driven mainly by demographic shifts.

Impact of Patent and Formulation Innovations

While patent cliffs have diminished for chlorzoxazone, formulation innovations such as sustained-release versions or combination products could open new revenue streams. These modifications aim to enhance compliance, reduce dosing frequency, and differentiate products in a crowded market.

Geographical Market Opportunities

Emerging markets in Asia, Africa, and Latin America present considerable growth potentials, owing to increasing healthcare access and rising prevalence of musculoskeletal ailments. Local manufacturing and partnerships with regional distributors can enhance market penetration.

Market Challenges and Risks

Safety Concerns and Regulatory Hurdles

Potential hepatotoxicity risks demand rigorous post-marketing safety surveillance, which can lead to restrictions or market withdrawals. Regulatory agencies may require risk management plans, increasing compliance costs.

Pricing Pressure and Market Saturation

Intense competition among generic manufacturers exerts downward pressure on prices, affecting profit margins. Additionally, clinical guidelines favoring alternative therapies could further dampen demand.

Drug Utilization in the Context of Personalized Medicine

Growing emphasis on individualized treatment may influence prescribing behaviors, favoring non-pharmacologic approaches or newer pharmacotherapies with better safety profiles, thus impacting chlorzoxazone's market share.

Future Market Trends and Opportunities

• Development of Novel Formulations: Extended-release or combination therapies could reinvigorate interest, provide additional benefits, and improve patient adherence.
• Enhanced Safety Profiling: Improving safety data through pharmacovigilance might bolster confidence among prescribers and regulators.
• Digital Health Integration: Utilizing telemedicine and electronic prescribing can improve access, especially in remote areas, supporting market expansion.

---

Key Takeaways

• Chlorzoxazone remains a relevant muscle relaxant largely driven by demographic trends and the healthcare burden of musculoskeletal disorders.
• The product's revenue trajectory is constrained by generic competition, safety concerns, and shifting therapeutic preferences.
• Market growth opportunities exist in emerging markets, formulation innovations, and safety profile improvements.
• Competitive landscape pressures necessitate strategic differentiation, cost optimization, and vigilant regulatory compliance.
• Stakeholders must monitor evolving treatment paradigms, safety regulations, and technological advancements to capitalize on future opportunities.

---

FAQs

1. What are the primary factors influencing chlorzoxazone's market growth?
   Demographic shifts, increasing prevalence of musculoskeletal disorders, and drug affordability drive growth, while competition, safety concerns, and alternative therapies pose challenges.

2. How does safety profile impact chlorzoxazone's market dynamics?
   Safety concerns, especially hepatotoxicity, influence prescribing habits, regulatory scrutiny, and post-marketing requirements, which can limit market expansion.

3. Are there any recent innovations related to chlorzoxazone?
   While no groundbreaking innovations are widely reported, research into sustained-release formulations and combination therapies aims to enhance efficacy and safety.

4. What regions present the most promising growth opportunities?
   Emerging markets in Asia, Africa, and Latin America exhibit significant growth potential due to increased healthcare access and rising disease prevalence.

5. How might new therapeutic developments affect chlorzoxazone's future market share?
   The introduction of newer, better-tolerated muscle relaxants and non-pharmacologic treatments could reduce chlorzoxazone's market share unless the drug adapts through innovation or repositioning.

---

References

1. [1] Global Burden of Disease Study, 2019.
2. [2] FDA Drug Database, Chlorzoxazone Information.
3. [3] Market research reports on generic pharmaceuticals, 2022.
4. [4] Regulatory updates on hepatotoxicity safety concerns, EMA, 2021.
5. [5] Industry analysis on muscle relaxants, IQVIA, 2022.