Skeletal Muscle Relaxant Drug Class List

Drugs in Drug Class: Skeletal Muscle Relaxant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Hikma	DANTROLENE SODIUM	dantrolene sodium	INJECTABLE;INJECTION	204762-001	Jun 19, 2017	AP	RX	No	No

Skeletal Muscle Relaxant Market Analysis and Financial Projection

The skeletal muscle relaxant drug market is experiencing steady growth driven by demographic shifts and chronic conditions, while its patent landscape reveals a mix of expiring patents and emerging innovations. Here's a comprehensive analysis:

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Market Dynamics

Growth Projections

• The global market reached USD 4.0B in 2024 (IMARC)[3] and is projected to grow to USD 7.05B by 2029 at an 8.1% CAGR (The Business Research Company)[7].
• Regional dominance: North America holds ~40% market share due to aging populations and advanced healthcare infrastructure, while Asia-Pacific is the fastest-growing region (4.4% CAGR) driven by rising musculoskeletal disorders[5][12].

Key Drivers

1. Aging Populations: Over 1.4B people aged ≥60 by 2030 increase demand for treatments for back pain, spasticity, and arthritis[7].
2. Rising Musculoskeletal Disorders: 60M+ annual U.S. prescriptions for muscle spasms and spasticity[9].
3. Sports Injuries & Accidents: Growing sports participation and road traffic accidents boost acute treatment needs[3].
4. Technological Advancements: Extended-release formulations (e.g., Amrix®) and novel delivery methods like intranasal cyclobenzaprine improve compliance[13][15].

Competitive Landscape

• Dominant Players: Teva Pharmaceuticals (Amrix®), Janssen (Flexeril®), and Sanochemia (tolperisone)[9][13].
• Market Segmentation:
  • By Drug Type: Skeletal muscle relaxants dominate (70%+ share)[3].
  • By Formulation: Cyclobenzaprine leads, followed by carisoprodol and methocarbamol[7].

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Patent Landscape

Key Patents & Expirations

Drug	Patent Holder	Patent Title/Number	Expiry	Impact
Amrix®	Teva Pharmaceuticals	Modified release dosage forms (US7387793)	Feb 2025[4]	Last expiring patent; generics expected post-2025[4][11].
Tolperisone	Katama Pharmaceuticals	Composition of matter (CA patents)	2032[9]	Grants U.S. market exclusivity as a non-sedating alternative[9].
Cyclobenzaprine	Multiple	Extended-release beads (US7544372)	Nov 2023[6]	Expired patents allow generic competition for Amrix®[6][8].

Innovation Trends

1. Formulation Advances:
   • Extended-release technologies: Multi-particulate dosage forms (e.g., Amrix®) provide 24-hour efficacy[8][15].
   • Non-sedating options: Tolperisone’s dual mechanism avoids CNS depression[9].
2. Delivery Methods: Intranasal cyclobenzaprine for rapid onset (WO2021064589A1)[13].

Legal Battles

• In re Cyclobenzaprine (2012): Cephalon defended Amrix®’s PK/PD profile patents (US7,387,793 and US7,544,372) against generic entrants[6][8].
• Generics Impact: 8 Amrix® patents expired in 2023, accelerating market competition[4][11].

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Strategic Outlook

• Generics Surge: Post-2025, Amrix® generics will reduce brand revenue but expand affordability[4][11].
• Pipeline Opportunities:
  • Tolperisone: Targeting a $8B U.S. branded market with Phase 2 trials underway[9].
  • Combination Therapies: Integration with NSAIDs or opioids for enhanced pain management[3].
• Regional Expansion: Asia-Pacific growth through partnerships (e.g., Katama-Sanochemia alliance)[9][14].

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Challenges

• Side Effect Risks: Sedation and dependency limit long-term use[3][12].
• Regulatory Hurdles: Stringent FDA requirements for new chemical entities (NCEs) like tolperisone[9].

Highlight: "The escalating number of sports injuries and aging populations are transforming skeletal muscle relaxants into a $7B+ therapeutic cornerstone by 2029" [7][12].

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Key Takeaways

• Market growth is demand-driven, with innovation focused on safety and efficacy.
• Patent cliffs (2023–2025) will reshape competition, favoring generics and novel agents like tolperisone.
• Emerging economies and non-oral formulations represent untapped potential.

For industry stakeholders, prioritizing R&D in targeted therapies and strategic IP management will be critical to sustaining growth in this evolving sector.

References

1. https://www.databridgemarketresearch.com/reports/global-muscle-relaxants-market
2. https://patents.google.com/patent/US2976213A/en
3. https://www.imarcgroup.com/muscle-relaxant-drugs-market
4. https://pharsight.greyb.com/drug/amrix-patent-expiration
5. https://www.polarismarketresearch.com/industry-analysis/muscle-relaxant-drugs-market
6. https://casetext.com/analysis/in-re-cyclobenzaprine-hydrochlorine-extended-release-capsule-patent-litigation
7. https://www.thebusinessresearchcompany.com/report/muscle-relaxant-drugs-global-market-report
8. https://www.patentdocs.org/2012/05/in-re-cyclobenzaprine-hydrochloride-extended-release-capsule-patent-litigation-fed-cir-2012.html
9. https://www.biospace.com/b-katama-pharmaceuticals-b-receives-a-notice-of-allowance-of-a-composition-of-matter-patent-for-tolperisone
10. https://patents.justia.com/patent/5190924
11. https://pharsight.greyb.com/ingredient/cyclobenzaprine-hydrochloride-patent-expiration
12. https://www.grandviewresearch.com/industry-analysis/muscle-relaxant-drugs-market-report
13. https://patents.google.com/patent/WO2021064589A1/en
14. https://www.marketresearch.com/VPA-Research-v4245/Muscle-Relaxant-Drugs-Size-Share-40319713/
15. https://patents.google.com/patent/US7387793B2/en
16. https://www.thebusinessresearchcompany.com/market-insights/muscle-relaxant-drugs-market-overview-2025