SKELAXIN Drug Patent Profile

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

Skelaxin is a drug marketed by King Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in SKELAXIN is metaxalone. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Skelaxin

A generic version of SKELAXIN was approved as metaxalone by SANDOZ on March 31^st, 2010.

Summary for SKELAXIN

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	119
Patent Applications:	2,597
Drug Prices:	Drug price information for SKELAXIN
Drug Sales Revenues:	Drug sales revenues for SKELAXIN
What excipients (inactive ingredients) are in SKELAXIN?	SKELAXIN excipients list
DailyMed Link:	SKELAXIN at DailyMed

See drug prices for SKELAXIN

See drug sales revenues for SKELAXIN

Paragraph IV (Patent) Challenges for SKELAXIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SKELAXIN	Tablets	metaxalone	800 mg	013217	1	2004-11-04

US Patents and Regulatory Information for SKELAXIN

SKELAXIN is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002		DISCN	Yes	No	7,122,566

Expired US Patents for SKELAXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002	7,714,006
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-001	Approved Prior to Jan 1, 1982	6,407,128
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002	6,683,102
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002	6,407,128
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-001	Approved Prior to Jan 1, 1982	6,683,102

International Patents for SKELAXIN

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

Country	Patent Number	Title	Estimated Expiration
Canada	2626027	PRODUITS A BASE DE METAXALONE, PROCEDE DE PREPARATION ET PROCEDE D'UTILISATION (METAXALONE PRODUCTS, METHOD OF MANUFACTURE, AND METHOD OF USE)
World Intellectual Property Organization (WIPO)	2007094825

SKELAXIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SKELAXIN (Metaxalone)

Introduction

SKELAXIN, known generically as metaxalone, is a muscle relaxant medication used to alleviate discomfort associated with acute, painful musculoskeletal conditions. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key segments, drivers, and regional performance.

Market Size and Growth

The global metaxalone market is projected to experience significant growth. By 2026, the market size is estimated to reach $5,770 million, growing at a Compound Annual Growth Rate (CAGR) of 6% during the 2021-2026 forecast period[1][4].

Market Segmentation by Indication

The metaxalone market is segmented based on various indications, including:

Bone Pain

The bone pain segment is the largest revenue generator, driven by the increasing cases of arthritis and other musculoskeletal disorders. Unhealthy lifestyles and a rise in outdoor activities contribute to this segment's growth[1][4].

Muscle Pain

The muscle pain segment is expected to register the fastest CAGR of 2.5% during the 2021-2026 period. This growth is attributed to the increasing incidence of muscle pain due to fitness activities and daily chores[1][4].

Joint Pain

Joint pain is another significant segment, driven by the prevalence of unhealthy lifestyles and inadequate nutrition, particularly among younger populations[4].

Tunnel Syndrome

Tunnel syndrome, though less common, is expected to see healthy growth due to ongoing research and development in this area[4].

Market Segmentation by End-Use Industry

The market is also segmented by end-use industry:

Hospitals

Hospitals hold the largest market share due to their easy accessibility, larger selling capacity, and the presence of skilled professionals. This segment dominates the market due to patient preference and higher selling capabilities[1][4].

Clinics

Clinics are the second-largest segment and are expected to grow as more clinics are opened worldwide, increasing their selling capacity and providing faster services[1][4].

Regional Performance

Geographically, the metaxalone market is diverse:

North America

North America, particularly the United States, dominates the market with a significant share of around 40% in 2020. This is due to the advanced healthcare system and the presence of major pharmaceutical companies[1][4].

Europe

Europe is seen as a lucrative market, especially due to the increasing elderly population and advancements in the pharmaceutical industry, particularly in Italy[1][4].

Asia Pacific

The Asia Pacific region is expected to outpace other regions with the highest CAGR during the forecast period, driven by a rising population and increasing development in healthcare infrastructure[1][4].

Market Drivers

Several factors drive the growth of the metaxalone market:

Growing Number of Musculoskeletal Disorders

The increasing incidence of musculoskeletal disorders such as arthritis, coupled with unhealthy lifestyles, is a significant driver[1][4].

Rise in Outdoor and Physical Activities

The growing trend of outdoor activities and fitness among urban populations increases the demand for metaxalone[1][4].

Pharmaceutical Industry Expansion

Expansion in the pharmaceutical industry, particularly in regions like Italy, provides multiple growth opportunities for metaxalone[4].

Regulatory Environment

Stricter drug prescribing laws by the World Health Organization and local government bodies have created opportunities for metaxalone as a prescribed medication[4].

Market Restraints

Despite the growth, there are some restraints:

Antitrust Litigation

Cases such as the Skelaxin (Metaxalone) Antitrust Litigation, where defendants were accused of conspiring to delay the entry of generic versions, can impact market dynamics[2].

Regulatory Challenges

Regulatory hurdles and the need for strict prescription compliance can limit market growth to some extent[4].

Key Market Participants

Several companies are leading the global metaxalone market, including:

• Biosynth
• Chunghwa Chemical Synthesis and Biotech
• Sigma Aldrich
• CDI Technology
• Angelini
• Pfizer
• Aurum Pharmatech
• Finetech Industry Limited
• Biochem
• Oxchem Corporation[1][4].

Financial Performance

In 2009, U.S. sales of Skelaxin exceeded $400 million, indicating the drug's significant financial impact[5].

Pharmacokinetics and Mechanism of Action

Metaxalone's mechanism of action, though not fully characterized, is believed to be related to its sedative properties. It does not have a direct action on the contractile mechanism of striated muscle, the motor end plate, or the nerve fiber. The pharmacokinetics of metaxalone show a proportional increase in peak plasma concentrations and area under the curve with dose escalation[3].

Conclusion

The metaxalone market, driven by the increasing incidence of musculoskeletal disorders and the expansion of the pharmaceutical industry, is poised for significant growth. With a projected market size of $5,770 million by 2026 and a CAGR of 6%, this market presents substantial opportunities for pharmaceutical companies. However, it must navigate regulatory challenges and antitrust litigation to maintain its trajectory.

Key Takeaways

• Market Size and Growth: Expected to reach $5,770 million by 2026 with a CAGR of 6%.
• Segmentation: Dominated by bone pain, followed by muscle pain and joint pain segments.
• End-Use Industry: Hospitals hold the largest market share, followed by clinics.
• Regional Performance: North America dominates, with Asia Pacific expected to grow rapidly.
• Market Drivers: Growing musculoskeletal disorders, outdoor activities, and pharmaceutical industry expansion.
• Market Restraints: Antitrust litigation and regulatory challenges.

FAQs

Q1: What is the primary use of SKELAXIN (metaxalone)? SKELAXIN (metaxalone) is primarily used as a muscle relaxant to alleviate discomfort associated with acute, painful musculoskeletal conditions.

Q2: Which segment dominates the metaxalone market? The bone pain segment dominates the metaxalone market, driven by increasing cases of arthritis and other musculoskeletal disorders.

Q3: What is the expected CAGR of the metaxalone market from 2021 to 2026? The metaxalone market is expected to grow at a CAGR of 6% from 2021 to 2026.

Q4: Which region is expected to outpace others in the metaxalone market growth? The Asia Pacific region is expected to outpace other regions with the highest CAGR during the forecast period.

Q5: What are some of the key market participants in the global metaxalone market? Key market participants include Biosynth, Chunghwa Chemical Synthesis and Biotech, Sigma Aldrich, CDI Technology, Angelini, Pfizer, and others.

Sources

1. IndustryARC: Metaxalone Market Size Report, 2021-2026.
2. Cornerstone Research: In re Skelaxin (Metaxalone) Antitrust Litigation.
3. Pfizer: SKELAXIN (metaxalone) tablets, for oral use.
4. Market Data Forecast: Metaxalone Market Size, Share & Growth Report, 2032.
5. Jones Day: King Pharmaceuticals wins preliminary injunction against Corepharma over generic version of Skelaxin.