Drugs in MeSH Category Muscle Relaxants, Central

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma Intl Pharms	METHOCARBAMOL	methocarbamol	TABLET;ORAL	085123-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Maia Pharms Inc	BACLOFEN	baclofen	INJECTABLE;INTRATHECAL	210048-001	Sep 11, 2019	AP	RX	No	No
Maia Pharms Inc	BACLOFEN	baclofen	INJECTABLE;INTRATHECAL	210048-002	Sep 11, 2019	AP	RX	No	No
Rubicon	BACLOFEN	baclofen	TABLET;ORAL	209102-001	Nov 28, 2017	AB	RX	No	Yes

Muscle Relaxants, Central Market Analysis and Financial Projection

The market for centrally-acting muscle relaxants is experiencing significant growth amid evolving patent landscapes and shifting therapeutic demands. Below is a detailed analysis of key dynamics shaping this pharmaceutical segment:

---

Market Dynamics

Growth Projections

• Value: The global muscle relaxant drugs market was valued at $3.68B in 2022 and is projected to grow at a 4.4–8.1% CAGR through 2030, reaching $7.05–$14.1B by 2030 depending on the source[1][10][15][18].
• Drivers:
  • Aging populations: Over 1.4 billion people aged 60+ by 2030[10][15], increasing demand for treatments for musculoskeletal disorders.
  • Chronic pain prevalence: 1.5 billion people globally suffer from chronic pain[16], with lower back pain being a leading contributor[1].
  • Innovative formulations: Examples include Amneal’s LYVISPAH (baclofen oral granules) for dysphagia patients[5] and Lupin’s Rocuronium Bromide Injection for surgical use[5].

Market Segmentation

Category	Key Components
By Drug Type	Cyclobenzaprine, Methocarbamol, Baclofen, Tizanidine[5][7]
By Route	Oral (dominant), Injectable (fastest-growing)[19]
By End-User	Hospitals (60% market share), Specialty Clinics, Homecare[15][16]

Competitive Landscape

• Key Players: Teva Pharmaceuticals, Amneal Pharmaceuticals, Lupin Limited, and Collegium Pharmaceutical[5][15].
• Strategies: Focus on generic launches (e.g., cyclobenzaprine generics post-Flexeril patent expiry[4][8]) and non-sedative alternatives to reduce side effects[16].

Emerging Trends

• Personalized medicine: Tailored dosing for geriatric patients[10].
• Botulinum toxin integration: Used alongside traditional relaxants for spasticity[5][10].
• Telemedicine adoption: Expanding access in Asia-Pacific and Latin America[16].

---

Patent Landscape

Key Patent Expirations & Litigation

Drug (Brand)	Active Ingredient	Patent Status
Flexeril	Cyclobenzaprine HCl	Historic litigation (1986 ANDA case vs. Merck’s ’246 patent)[8]
Amrix	Cyclobenzaprine ER	Tentative FDA approvals for generics (15mg/30mg capsules)[4]
LYVISPAH	Baclofen	FDA approval in 2021 with no significant patent barriers reported[5]

Impact of Generics

• Cyclobenzaprine: Post-patent, 62 suppliers now offer generic versions, driving price competition[4].
• Methocarbamol: Despite approval in 1957, 53 applicants and 74 NDAs indicate ongoing generic interest[2].

Regulatory & Clinical Developments

• 505(b)(2) Pathways: Used for reformulations like extended-release cyclobenzaprine[4].
• Clinical Trials:
  • Phase 4 studies for cyclobenzaprine in military and chronic pain settings[4].
  • Phase 3 trials for methocarbamol in arthritis management[2].

---

Challenges & Opportunities

• Restraints: Side effects (drowsiness, habituation) and stringent FDA regulations[16][17].
• Opportunities:
  • Non-opioid alternatives: Demand surged post-opioid crisis[16].
  • Emerging markets: Asia-Pacific’s CAGR projected at 6.3% due to healthcare investments[15][19].

---

"The aging population and rising musculoskeletal disorders are reshaping the muscle relaxant market, with innovation in drug delivery systems becoming a critical differentiator." – Grand View Research[18]

This sector’s future hinges on balancing generic competition with novel formulations, while addressing regulatory and safety concerns to meet growing global demand.

References

1. https://www.databridgemarketresearch.com/reports/global-muscle-relaxants-market
2. https://www.drugpatentwatch.com/p/generic/methocarbamol
3. https://en.wikipedia.org/wiki/Muscle_relaxant
4. https://www.drugpatentwatch.com/p/generic/cyclobenzaprine+hydrochloride
5. https://www.thebusinessresearchcompany.com/report/muscle-relaxant-drugs-global-market-report
6. https://www.pharmamanufacturing.com/home/article/55249347/key-drugs-losing-patent-protection-in-2025
7. https://www.drugs.com/drug-class/skeletal-muscle-relaxants.html
8. https://law.justia.com/cases/federal/district-courts/FSupp/694/1/1874712/
9. https://patents.google.com/patent/EP0273744A2/en
10. https://www.researchandmarkets.com/reports/5790707/muscle-relaxant-drugs-market-report
11. https://www.pharmacompass.com/chemistry-chemical-name/assival
12. https://patents.google.com/patent/US4722938A/en
13. https://www.geneonline.com/a-look-at-2024s-patent-expirations-and-generic-competition/
14. https://www.ncbi.nlm.nih.gov/mesh/68009125
15. https://www.polarismarketresearch.com/industry-analysis/muscle-relaxant-drugs-market
16. https://www.verifiedmarketreports.com/product/muscle-relaxants-drugs-market/
17. https://www.researchandmarkets.com/report/muscle-relaxant
18. https://www.grandviewresearch.com/industry-analysis/muscle-relaxant-drugs-market-report
19. https://www.techsciresearch.com/report/muscle-relaxant-drugs-market/17190.html