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-three 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
Patent Applications:	3,938
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
Medtronic	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

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
Netherlands	141379
United Kingdom	1017439
Austria	256081
France	3692

LIORESAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LIORESAL (Baclofen)

Introduction to LIORESAL (Baclofen)

LIORESAL, commonly known by its generic name baclofen, is a muscle relaxant drug used primarily to treat muscle spasticity, a condition often associated with neurological disorders such as multiple sclerosis, cerebral palsy, and spinal cord injuries.

Global Market Size and Growth

The global baclofen market, which includes LIORESAL, was valued at approximately USD 1723.9 million in 2023 and is projected to reach USD 2851.83 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.20% during the forecast period from 2024 to 2032[3].

Segmentation and Outlook

Drug Type Outlook

Baclofen falls under the category of skeletal muscle relaxant drugs. This segment is part of the broader muscle relaxant drugs market, which is expected to grow significantly due to the increasing prevalence of chronic pain and musculoskeletal disorders[5].

Route of Administration

Baclofen is available in various forms, including oral and intrathecal (injectable) routes. The intrathecal form, delivered through an implanted infusion system, is gaining prominence due to its targeted drug delivery and potential for reducing side effects associated with oral administration[2].

Distribution Channels

The distribution channels for baclofen include hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies captured the highest revenue share in 2022, driven by increasing clinical and hospital visits, particularly among the geriatric population[1].

Regional Insights

North America

North America dominates the global baclofen market, driven by high-quality healthcare infrastructure, significant investment in healthcare, and a high incidence of chronic diseases[1][3].

Asia Pacific

The Asia Pacific region is witnessing significant growth, driven by an aging population and an increase in spinal cord injuries and neurological disorders in countries like China, Japan, and India. Generic manufacturers in this region play a crucial role in making baclofen more accessible at affordable prices[3].

Latin America

Latin America, particularly Brazil, is also seeing moderate growth, driven by the rise in neurological disorders and expanding healthcare infrastructure. However, economic constraints and lack of awareness about neurological treatments are challenges in this region[3].

Key Drivers and Challenges

Drivers

• Increasing Prevalence of Neurological Disorders: Conditions such as multiple sclerosis, cerebral palsy, and spinal cord injuries are driving the demand for baclofen to manage muscle spasticity[3].
• Aging Population: The growing geriatric population is a significant factor, as elderly individuals are more likely to be admitted to hospitals for chronic diseases, increasing the demand for muscle relaxant drugs[1].
• Advancements in Drug Delivery: Targeted drug delivery systems, such as intrathecal baclofen, are reducing side effects and improving patient outcomes, thereby increasing adoption[2].

Challenges

• Side Effects: Oral baclofen can have intolerable, dose-dependent side effects, which can limit its use. However, intrathecal delivery is mitigating this issue to some extent[2].
• Economic Constraints: In regions like Latin America, economic constraints and lack of widespread awareness about neurological treatments can hinder market growth[3].

Financial Trajectory

Cost-Effectiveness

Studies have shown that while the initial costs of intrathecal baclofen delivery are high due to device and implantation costs, these costs decrease significantly over time. By the third year after implantation, the costs can reach cost neutrality, indicating long-term cost savings[2].

Market Projections

The global baclofen market is expected to grow from USD 1723.9 million in 2023 to USD 2851.83 million by 2032. This growth is part of the broader muscle relaxant drugs market, which is projected to reach USD 9.4 billion by 2032, growing at a CAGR of 6.4% from 2023 to 2032[3][5].

Strategic Activities and Market Players

Key players in the market, such as LGM Pharma, Lannett, and Novartis Pharma Schweiz, are focusing on the development of novel products and expanding their presence in various regions. For instance, Saol Therapeutics received U.S. FDA approval for LYVISPAH (baclofen) oral granules, and Eisai Co., Ltd. has agreements to expand its muscle relaxant drug presence in Asia and Latin America[1][3].

Patient Assistance Programs

To make LIORESAL more accessible, companies like Saol Therapeutics and Amneal have partnered with programs such as NeedyMeds and the Amneal Patient Assistance Program to offer free medication to eligible individuals who are uninsured or underinsured[4].

Key Takeaways

• The global baclofen market is growing at a CAGR of 5.20% from 2024 to 2032.
• North America dominates the market, but the Asia Pacific region is expected to witness significant growth.
• Intrathecal baclofen delivery is becoming more popular due to its targeted drug delivery and potential for reducing side effects.
• Economic constraints and lack of awareness are challenges in certain regions.
• Patient assistance programs are available to make the drug more accessible to those in need.

FAQs

1. What is the primary use of LIORESAL (baclofen)?

   • LIORESAL (baclofen) is primarily used to treat muscle spasticity associated with neurological disorders such as multiple sclerosis, cerebral palsy, and spinal cord injuries.

2. What is the expected growth rate of the global baclofen market?

   • The global baclofen market is expected to grow at a CAGR of 5.20% from 2024 to 2032.

3. Which region is expected to drive the global baclofen market?

   • North America is expected to dominate the global baclofen market, although the Asia Pacific region is witnessing significant growth.

4. What are the significant factors driving the global baclofen market?

   • The increasing prevalence of neurological disorders, an aging population, and advancements in drug delivery systems are significant drivers.

5. Are there patient assistance programs available for LIORESAL (baclofen)?

   • Yes, companies like Saol Therapeutics and Amneal offer patient assistance programs to provide free medication to eligible individuals who are uninsured or underinsured.

Cited Sources:

1. Grand View Research - Muscle Relaxant Drugs Market Size & Share Report, 2030
2. PubMed - Assessment of Health Care Costs and Total Baclofen Use
3. Market Research Store - Baclofen Market Size, Share, Industry Demand, Forecast Report 2032
4. Lioresal - Patient Assistance - Lioresal Intrathecal (baclofen injection)
5. GMI Insights - Muscle Relaxant Drugs Market Size & Share Report, 2032