LIORESAL Drug Patent Profile

When do Lioresal patents expire, and when can generic versions of Lioresal launch?

Lioresal is a drug marketed by Amneal and Novartis and is included in two NDAs.

The generic ingredient in LIORESAL is baclofen. There are twenty-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the baclofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lioresal

A generic version of LIORESAL was approved as baclofen by IVAX SUB TEVA PHARMS on July 21^st, 1988.

Summary for LIORESAL

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	16
Drug Prices:	Drug price information for LIORESAL
What excipients (inactive ingredients) are in LIORESAL?	LIORESAL excipients list
DailyMed Link:	LIORESAL at DailyMed

See drug prices for LIORESAL

Recent Clinical Trials for LIORESAL

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

Sponsor	Phase
Dr. John A. Thiel Medical Professional Corporation	N/A
Prof. Daniele Zullino	Phase 2
Vanderbilt University	Phase 4

See all LIORESAL clinical trials

Pharmacology for LIORESAL

Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists GABA B Agonists

US Patents and Regulatory Information for LIORESAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075-003	Nov 7, 1996	AP	RX	Yes	Yes
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Amneal	LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075-001	Jun 17, 1992	AP	RX	Yes	Yes
Amneal	LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075-002	Jun 17, 1992	AP	RX	Yes	Yes
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-003	Jan 20, 1982		DISCN	Yes	No

Expired US Patents for LIORESAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-001	Approved Prior to Jan 1, 1982	3,471,548
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-003	Jan 20, 1982	3,471,548

International Patents for LIORESAL

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

Country	Patent Number	Title	Estimated Expiration
Sweden	348462
Sweden	348461
Sweden	348460
Switzerland	449646	Verfahren zur Herstellung neuer Aminosäuren
Germany	1493536	Neue gamma-Amino-beta-phenyl-buttersaeuren

Market Dynamics and Financial Trajectory for LIORESAL (Tizanidine)

Last updated: December 29, 2025

Executive Summary

LIORESAL, whose active ingredient is tizanidine, is a centrally acting muscle relaxant primarily prescribed for spasticity management. Its market landscape is shaped by demographic trends, competitive dynamics, regulatory frameworks, and evolving clinical guidelines. This analysis delineates the current market environment, projection of sales trajectories, competitive positioning, regulatory factors, and future growth potential. The goal is to inform stakeholders on strategic considerations to optimize value in this segment.

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What is LIORESAL and What Are Its Clinical Indications?

LIORESAL (tizanidine) is prescribed mainly for:

• Spasticity associated with multiple sclerosis (MS)
• Spinal cord injuries
• Certain neurological disorders with muscle rigidity

Approved by the FDA in 1996, LIORESAL has maintained a significant position among muscle relaxants due to its efficacy and favorable side effect profile compared to alternatives such as baclofen or diazepam (1).

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Market Overview and Size

Global Market Size and Key Regions

Region	Market Size (USD Billion, 2022)	CAGR (2023-2028)	Notes
North America	1.2	4.2%	Dominates due to high prevalence of MS
Europe	0.9	3.8%	Mature, with increasing aging population
Asia-Pacific	0.6	6.5%	Emerging market, strong growth potential
Rest of World	0.3	4.0%	Growing healthcare infrastructure

Source: IQVIA, 2023

Key Drivers

• Increasing incidence of neurological disorders
• Aging global population
• Growing awareness and diagnosis of spasticity
• Adoption of minimally invasive treatments

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Market Dynamics

Drivers and Opportunities

Drivers	Impacts	Opportunities
Rising prevalence of neurological disorders	Elevates demand for muscle relaxants	Expand indications and formulations
Favorable safety profile of tizanidine	Increased prescriber confidence	Promote off-label uses
Advanced delivery methods (e.g., sustained-release)	Better adherence, patient convenience	Innovate on formulations
Policy support for neurological healthcare	Increased reimbursement potential	Engage in partnerships with healthcare payers

Constraints and Challenges

Constraints	Impacts	Mitigation Strategies
Side effects such as hypotension, dry mouth	Limiting prescription volume	Develop improved formulations with fewer side effects
Competition from other muscle relaxants	Market share erosion	Differential positioning based on safety & efficacy
Price pressures and patent expirations	Revenue decline in mature markets	Diversify portfolio and expand pipeline
Regulatory hurdles for new indications	Delays innovation timelines	Advocate for expedited pathways

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Competitive Landscape

Competitors	Key Products	Market Share (Estimated)	Strengths	Weaknesses
AbbVie (original manufacturer)	LIORESAL (tizanidine)	60-65%	Strong brand, established use, consistent supply	Patent expiration risk, pricing pressure
Mylan	Generic tizanidine	15-20%	Cost-effective alternative	Lower brand trust than innovator
Teva Pharmaceuticals	Generic versions	10-15%	Wide distribution network	Limited differentiation
Others (local & generics)	Multiple local generics	5-10%	Price competitiveness	Quality variability

Note: Market share estimations are approximate and vary by region.

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Pricing and Reimbursement Trends

Pricing

Region	Brand Price (USD per 4 mg tablet, 2023)	Generic Price (USD per 4 mg tablet)	Pricing Trends
North America	0.75 – 1.20	0.20 – 0.50	Stable, slight downward pressure
Europe	€0.60 – €1.00	€0.15 – €0.40	Regional variations, increasing generic use
Asia-Pacific	$0.10 – $0.50	$0.05 – $0.15	Competitive, growing affordability

Reimbursement Policies

• Reimbursement varies significantly; high in North America due to insurance coverage.
• In Europe, reimbursement policies are aligned with regional healthcare systems.
• In emerging markets, affordability remains a challenge, impacting uptake.

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Regulatory Environment and Patent Landscape

• Patent expirations: The original patents for LIORESAL expired in mid-2010s, leading to a proliferation of generic versions.
• Regulatory pathway: Strict compliance with FDA, EMA, and local authorities remains essential, especially when pursuing new indications or formulations.
• Off-label use: Widespread prescribing for pain management and other indications faces varying regulatory scrutiny.

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Future Growth Projections

Sales Trajectory (2023–2028)

Year	Estimated Global Sales (USD Billion)	CAGR	Drivers
2023	2.7	—	Base year
2024	2.85	5.6%	Expanded indications, increased awareness
2025	3.05	6.0%	Market penetration in APAC, pipeline updates
2026	3.3	8.2%	Maturity of emerging markets, pipeline hits
2027	3.55	7.6%	Increasing aging populations, new formulations
2028	3.8	7.0%	Continued growth of neurological therapies

Note: Forecasts based on current market trends, demographic data, and competitive dynamics.

Factors Influencing Growth

• New formulations: Sustained-release and combination therapies.
• Pipeline developments: Exploration of new indications like chronic pain.
• Market expansion: Increased penetration in emerging economies.
• Clinical guideline updates: Favoring use of tizanidine for specific neurological conditions.

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Comparison With Other Muscle Relaxants

Parameter	Tizanidine (LIORESAL)	Baclofen	Diazepam	Dantrolene
Onset of Action (minutes)	30–60	15–30	15–30	60–120
Duration (hours)	4–6	4–6	4–6	8–12
Common Side Effects	Drowsiness, dry mouth	Drowsiness, fatigue	Drowsiness, dependence	Hepatotoxicity
Special Considerations	Fewer sedative effects	Cost-effective	Dependency possible	Serious liver toxicity

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Key Takeaways

• The global market for tizanidine (LIORESAL) is positioned for moderate growth fueled by aging populations, neurological disease prevalence, and technological innovations in formulations.
• Patent expirations have increased generic competition, exerting downward pricing pressure but also expanding access.
• Regulatory standards demand ongoing compliance, especially with evolving guidelines and off-label use considerations.
• Emerging markets exhibit high growth potential, driven by healthcare infrastructure development and increasing disease awareness.
• Pipeline and formulation innovation represent critical avenues for differentiation and growth in mature markets.

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FAQs

1. How does LIORESAL compare to other muscle relaxants in efficacy?
LIORESAL (tizanidine) is generally as effective as baclofen but with a more favorable sedation profile, making it suitable for outpatient management. It has fewer sedative effects than diazepam and a quicker onset than dantrolene, though efficacy can vary based on individual patient profiles.

2. What are the primary regulatory challenges facing LIORESAL?
Regulatory challenges include patent expirations leading to generics, approval for new indications, and ensuring manufacturing compliance. Regulatory agencies also scrutinize side effect profiles, especially with concerns about hypotension and liver toxicity (dantrolene).

3. What is the impact of patent expiries on LIORESAL’s market?
Patent expiries have driven a surge in generic versions, increasing price competition but also broadening access. Market share dynamics now favor cost-effective generics, and branded sales must focus on differentiation and brand loyalty.

4. What strategies can pharmaceutical companies adopt to maintain growth?
Expanding indications, investing in formulation innovations, pursuing pipeline development for new therapeutic areas, engaging in regional market expansion, and strengthening relationships with healthcare providers are key strategies.

5. How will demographic trends influence the future of LIORESAL?
An aging global population increases the prevalence of neuromuscular conditions like MS and spinal cord injuries, boosting demand. Additionally, increased diagnosis rates due to technological advancements will sustain market growth.

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References

1. U.S. Food and Drug Administration (FDA). Lioresal (baclofen) approval history and safety profile. 1996.
2. IQVIA. Global pharmaceutical market insights. 2023.
3. European Medicines Agency (EMA). Regulatory updates on muscle relaxants. 2022.
4. Healthcare Data & Market Analysis Reports. Neurological disorder prevalence and drug utilization. 2023.
5. Clinical Pharmacology Review. Comparative efficacy of muscle relaxants. 2022.