METAXALONE - Generic Drug Details

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

Metaxalone is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Amneal Pharms, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Rising, Sandoz, Sciegen Pharms Inc, and King Pharms, and is included in ten NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metaxalone has eight patent family members in seven countries.

There are twenty drug master file entries for metaxalone. Thirty-four suppliers are listed for this compound.

Summary for METAXALONE

International Patents:	8
US Patents:	2
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	3
Patent Applications:	3,756
Drug Prices:	Drug price trends for METAXALONE
Drug Sales Revenues:	Drug sales revenues for METAXALONE
What excipients (inactive ingredients) are in METAXALONE?	METAXALONE excipients list
DailyMed Link:	METAXALONE at DailyMed

See drug prices for METAXALONE

See drug sales revenues for METAXALONE

Recent Clinical Trials for METAXALONE

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

Sponsor	Phase
Primus Pharmaceuticals	Phase 4
Illumination Health	Phase 4
Rothman Institute Orthopaedics	N/A

See all METAXALONE clinical trials

Pharmacology for METAXALONE

Drug Class	Muscle Relaxant
Physiological Effect	Centrally-mediated Muscle Relaxation

Paragraph IV (Patent) Challenges for METAXALONE

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

US Patents and Regulatory Information for METAXALONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lannett Co Inc	METAXALONE	metaxalone	TABLET;ORAL	204770-001	Nov 22, 2016	AB	RX	No	No
Mountain	METAXALONE	metaxalone	TABLET;ORAL	040486-001	Feb 27, 2015	AB	RX	No	No
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695-001	Jun 15, 2017	AB	RX	No	No
Rising	METAXALONE	metaxalone	TABLET;ORAL	208774-001	Sep 24, 2018	BX	RX	No	No
Sciegen Pharms Inc	METAXALONE	metaxalone	TABLET;ORAL	207466-002	Mar 13, 2020	AB	RX	No	No
King Pharms	SKELAXIN	metaxalone	TABLET;ORAL	013217-003	Aug 30, 2002		DISCN	Yes	No

Expired US Patents for METAXALONE

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

International Patents for METAXALONE

Country	Patent Number	Title	Estimated Expiration
Japan	2022539368	低用量のメタキサロン製剤
Australia	2020307390	Reduced dose metaxalone formulations
World Intellectual Property Organization (WIPO)	2020263768
World Intellectual Property Organization (WIPO)	2007094825
European Patent Office	3989946	FORMULATIONS DE MÉTAXALONE À DOSE RÉDUITE (REDUCED DOSE METAXALONE FORMULATIONS)
South Korea	20220025815	용량이 감소된 메탁살론 제형

METAXALONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Metaxalone

Introduction to Metaxalone

Metaxalone, commonly known by its brand name Skelaxin, is a muscle relaxant medication used to treat musculoskeletal pain and discomfort. It works by affecting the brain's nerve impulses, rather than directly on the skeletal muscles, to provide relief from muscle spasms and pain associated with strains, sprains, and other musculoskeletal conditions[2][4][5].

Market Size and Growth

The global metaxalone market is projected to experience significant growth over the coming years. 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[4].

Market Drivers

Several factors are driving the growth of the metaxalone market:

• Increasing Musculoskeletal Disorders: The rise in musculoskeletal disorders such as arthritis, particularly due to unhealthy lifestyles, is a major driver. This increase in conditions like arthritis and other musculoskeletal problems is expected to continue, fueling the demand for metaxalone[1][4].
• Growing Number of Injuries: An increase in road accidents and outdoor physical activities, including sports and gym workouts, contributes to the higher incidence of injuries that require muscle relaxants like metaxalone[1][4].
• Aging Population: The growing elderly population, especially in Europe, is another significant factor. Older individuals are more prone to joint, bone, and muscle problems, which increases the demand for metaxalone[1][4].
• Pharmaceutical Industry Expansion: The expansion of the pharmaceutical industry, particularly in countries like Italy, is expected to provide multiple growth opportunities for metaxalone[1].

Market Restraints

Despite the positive growth drivers, there are several challenges that could impede the market growth:

• Increasing Side Effects: Metaxalone is associated with various side effects such as drowsiness, dizziness, headache, nausea, and irritability. These side effects can deter some patients from using the drug, potentially slowing market growth[4].
• Stringent Government Regulations: Strict government regulations and approval processes can create hurdles for the metaxalone market. For instance, the World Health Organization and local government bodies have tightened drug prescribing laws, which can affect market dynamics[1][4].

Segment Analysis by Indication

The metaxalone market can be segmented based on indication:

• Bone Pain: This segment accounts for the largest share of the market due to the increasing cases of arthritis and other bone-related conditions. Bone pain is expected to register profitable growth during the forecast period[1][4].
• Muscle Pain: This segment is estimated to register the fastest CAGR of 2.5% during the 2021-2026 period. The growth is driven by the increasing use of metaxalone to reduce musculoskeletal pain[4].
• Joint Pain and Tunnel Syndrome: These segments are also expected to see reasonable growth rates due to the prevalence of joint problems and the need for ongoing research and development in treating tunnel syndrome[1][4].

Segment Analysis by End-Use Industry

The market can also be segmented based on end-use industry:

• Hospitals: Hospitals hold the largest market share due to their easy accessibility and higher selling capacity. The credibility and availability of skilled professionals in hospitals make them a preferred choice for patients[1][4].
• Clinics: Clinics are expected to register a CAGR of 1.5% over the forecast period. The increasing number of clinics and their extended operating hours contribute to their growing market share[4].

Geographical Analysis

Geographically, the metaxalone market is dominated by:

• North America: This region holds the largest market share due to the presence of advanced healthcare systems and significant developments in the pharmaceutical industry. North America, particularly the United States, is expected to continue its dominance[1][4].
• Europe: Europe is seen as a lucrative market due to the increasing number of older people and the expansion of the pharmaceutical industry in countries like Italy[1].
• Asia Pacific: This region is expected to outpace other regions with the highest CAGR during the forecast period, driven by the rising population and increasing development in healthcare infrastructure[4].

Key Market Participants

Several key players 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].

Financial Impact and Revenue

The financial trajectory of the metaxalone market is positive, with projected revenues reaching $5,770 million by 2026. The market's growth is supported by the increasing demand for muscle relaxants due to musculoskeletal disorders and the expanding pharmaceutical industry.

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the metaxalone market. While lockdowns and reduced outdoor activities temporarily reduced the number of accidents and injuries, thereby decreasing demand, the long-term effects of the pandemic on healthcare systems and lifestyles are likely to increase the incidence of musculoskeletal disorders, thus supporting market growth[4].

Addiction and Abuse Considerations

While metaxalone is generally safe when used as prescribed, there is a risk of addiction and abuse if the drug is taken in higher doses or by individuals without a prescription. This can lead to adverse effects and withdrawal symptoms, which can impact the market negatively if not managed properly[2].

"Muscle relaxant abuse occurs when someone who has either been prescribed the drug by your doctor or pharmacist takes more than the ordered therapeutic doses or when someone who does not have a prescription uses the drug." - Resurgence Behavioral Health[2]

Key Takeaways

• The global metaxalone market is expected to grow significantly, driven by increasing musculoskeletal disorders and an aging population.
• The market is segmented by indication, with bone pain being the largest segment, and by end-use industry, with hospitals holding the largest share.
• North America dominates the market, but the Asia Pacific region is expected to grow at the highest CAGR.
• Key market participants include major pharmaceutical companies like Pfizer and Angelini.
• The market faces challenges such as increasing side effects and stringent government regulations.

Frequently Asked Questions

What is Metaxalone Used For?

Metaxalone is used to help relax muscles and relieve discomfort caused by acute, painful muscle or bone conditions such as strains, sprains, and musculoskeletal disorders[2][5].

What Are the Common Side Effects of Metaxalone?

Common side effects include drowsiness, dizziness, headache, nervousness, irritability, nausea, vomiting, and upset stomach[2][5].

Can Metaxalone Be Addictive?

Yes, metaxalone can be addictive if taken in higher doses than prescribed or by individuals without a prescription. This can lead to physical and psychological dependence[2].

Which Regions Dominate the Metaxalone Market?

North America, particularly the United States, dominates the metaxalone market due to its advanced healthcare system and significant pharmaceutical industry developments. Europe and the Asia Pacific region are also significant markets[1][4].

What Are the Major Market Restraints for Metaxalone?

Major market restraints include increasing side effects, stringent government regulations, and the impact of the COVID-19 pandemic on outdoor activities and healthcare systems[1][4].

Sources:

1. Market Data Forecast, "Metaxalone Market Size, Share & Growth Report, 2032"
2. Resurgence Behavioral Health, "Metaxalone Abuse, Addiction, and Treatment"
3. Pfizer Inc., "Appendix A 2012 Financial Report"
4. IndustryARC, "Metaxalone Market Size Report, 2021-2026"
5. Mayo Clinic, "Metaxalone (oral route) - Mayo Clinic"