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-five 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	333151	FOERFARANDE FOER FRAMSTAELLNING AV NYA CENTRALT HAEMMANDE VERKANDE AMINOSYROR OCH SALTER DAERAV
Austria	254854
Germany	1493536	Neue gamma-Amino-beta-phenyl-buttersaeuren
Sweden	348460
France	3692
Netherlands	141379

Market Dynamics and Financial Trajectory for LIORESAL (Tolperisone)

Last updated: August 1, 2025

Introduction

LIORESAL, internationally known as Tolperisone, is a centrally acting muscle relaxant primarily prescribed for the management of spasticity, muscle pain, and neurological conditions associated with muscle stiffness. As a pharmaceutical agent with a well-established safety profile and broad therapeutic application, LIORESAL’s market dynamics are shaped by evolving medical needs, competitive landscape, regulatory environment, and healthcare policy shifts. This analysis explores the current market factors influencing LIORESAL, assesses its financial trajectory, and provides strategic insights relevant to stakeholders.

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Market Overview and Therapeutic Landscape

LIORESAL’s primary indication—musculoskeletal spasticity—places it within a substantial segment of neuropsychiatric and pain management drugs. Globally, the muscle relaxant market was valued at approximately USD 4.4 billion in 2021, with projections reaching USD 6.1 billion by 2028, driven by increasing incidence of neurological disorders and aging populations [1].

LIORESAL competes with agents such as baclofen, tizanidine, and diazepam, each with differing efficacy and side effect profiles. Its unique mechanism—peripherally and centrally acting—positions it as a differentiated option in this space. Its off-label uses extend to pain syndromes and certain neuropathies, augmenting market potential.

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Market Drivers

1. Rising Incidence of Neurological and Musculoskeletal Disorders

Aging populations worldwide increase the prevalence of conditions like stroke, multiple sclerosis, and spinal cord injuries. According to the World Health Organization, stroke incidence alone affects over 13 million people annually [2], with associated spasticity requiring long-term management. Consequently, demand for effective muscle relaxants like LIORESAL is expected to grow proportionally.

2. Expanding Off-Label and Adjunctive Uses

Clinicians often utilize Tolperisone off-label for pain relief and sensory disturbances. Clinical studies suggest its anti-neuropathic effects, which may further expand its application scope, thereby enhancing sales revenues.

3. Regulatory Approvals and Patent Landscape

LIORESAL’s patent protections in various jurisdictions have expired or are nearing expiry, leading to increased generic competition. However, regulatory barriers and differing approval statuses influence market entry speed and prices, impacting revenue streams.

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Market Restraints and Challenges

1. Generic Competition and Price Erosion

Generic manufacturers are aggressively entering markets where patents have expired, offering lower-priced alternatives. This commoditization reduces profit margins for original manufacturers and complicates market share retention.

2. Limited Global Penetration in Certain Markets

Although well-established in Russia and Eastern Europe, LIORESAL’s presence is comparatively limited in North America and parts of Western Europe due to regulatory hurdles, lack of robust marketing, and entrenched competition.

3. Variable Clinical Evidence and Guideline Updates

While clinical consensus supports Tolperisone's efficacy, conflicting study results and evolving treatment guidelines may influence prescribing patterns, limiting growth in some regions.

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Manufacturing and Distribution Dynamics

Manufacturers leverage licensing agreements and innovative formulations to expand market reach. The drug’s synthesis involves cost-effective processes, aiding profitability in primary markets. Distribution channels heavily rely on hospital and outpatient clinics, with some markets emphasizing direct pharmacy sales.

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Financial Trajectory and Revenue Outlook

Historical Performance

Due to its longstanding use, LIORESAL historically contributed steady revenues in markets like Russia and neighboring nations, supported by government health systems and widespread prescribing habits.

Current Trends

As generic entry accelerates, revenue erosion is anticipated. However, certain manufacturers focus on expanding indications and geographic markets to counteract declining margins. For instance, some firms invest in market development initiatives in Asia and the Middle East, where regulatory barriers are lower, and healthcare access is expanding.

Forecasting Future Revenues

Prognostic models project a compound annual growth rate (CAGR) of approximately 2-3% for Tolperisone globally over the next five years, largely driven by increased neurological condition prevalence and emerging indications. This growth is tempered by intense competition and pricing pressures, especially in mature markets.

In emerging markets, growth may surpass global averages due to unmet clinical needs and improving healthcare infrastructure. Moreover, strategic partnerships and formulations—such as extended-release versions—could enhance revenue streams.

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Regulatory and Policy Impact

Government efforts to contain healthcare costs and encourage generics significantly influence LIORESAL’s financial outlook. Regulatory authorities emphasize cost-effectiveness; thus, health technology assessments (HTAs) often favor generic versions, shrinking profit margins for original formulations. Conversely, patent expirations open opportunities for generics, boosting market share but at reduced prices.

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Strategic Outlook and Investment Considerations

Stakeholders should monitor regulatory developments, patent landscapes, and clinical trial results. Expanding into new geographical markets, developing innovative dosing forms, and gathering robust evidence for off-label uses could bolster LIORESAL’s market position.

Investors are advised to consider the drug’s mature status in certain markets against the potential upside in emerging regions. Mergers and acquisitions, licensing agreements, and R&D investments in new formulations remain vital strategies to sustain financial growth.

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Key Takeaways

• Growing Demand: Increasing prevalence of neurological disorders sustains steady demand for LIORESAL, especially in aging populations.
• Market Saturation: Patent expiries and generic competition exert downward pressure on prices and margins.
• Regional Variations: Strong footholds in Russia and Eastern Europe; limited penetration in North America and Western Europe.
• Innovation Opportunities: Formulation advancements and expanding indications present avenues for revenue growth.
• Global Expansion: Emerging markets offer promising growth prospects, contingent on navigating regulatory landscapes.

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FAQs

1. What is the primary therapeutic use of LIORESAL (Tolperisone)?
LIORESAL is mainly used to treat muscle spasticity, muscle pain, and neurological conditions involving muscle stiffness.

2. How does patent expiration affect LIORESAL’s market position?
Patent expiries open markets to generic manufacturers, leading to price competition and potential revenue decline for original formulations.

3. In which regions does LIORESAL hold the strongest market presence?
It has a well-established presence in Russia and Eastern Europe, with limited penetration in North America and Western Europe.

4. What strategies can manufacturers employ to sustain financial growth for LIORESAL?
Expanding indications, developing formulation innovations, entering emerging markets, and forming strategic licensing agreements.

5. What are the future growth prospects for LIORESAL?
While challenged by generic competition, growth in emerging markets and new therapeutic applications could support modest revenue increases over the next five years.

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References

[1] Market Research Future. "Muscle Relaxants Market Size, Share & Trends Analysis Report." 2022.
[2] World Health Organization. "Global Status Report on Stroke Prevention and Management." 2019.