Physiological Effect: Decreased Striated Muscle Tone

Drugs with Physiological Effect: Decreased Striated Muscle Tone

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	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
Endo Operations	DANTRIUM	dantrolene sodium	INJECTABLE;INJECTION	018264-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Impax Labs	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076856-001	Mar 1, 2005	AB	RX	No	No
Impax Labs	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076856-002	Mar 1, 2005	AB	RX	No	No

Decreased Striated Muscle Tone Market Analysis and Financial Projection

The market for drugs that decrease striated muscle tone, including skeletal muscle relaxants and neuromuscular blockers, is experiencing significant growth alongside evolving patent dynamics. Here's a detailed analysis:

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Market Dynamics

1. Growth Projections

   • The global muscle relaxant drugs market is projected to grow from $4.1 billion in 2022 to $9.4 billion by 2032, at a CAGR of 6.4% [16]. Near-term estimates suggest a rise from $4.77 billion in 2024 to $5.16 billion in 2025 (CAGR: 8.1%) [1].
   • Key drivers include:
     • Aging populations and rising chronic conditions (e.g., lower back pain, fibromyalgia) [6].
     • Increased surgical procedures requiring neuromuscular blockers [1].
     • Advances in targeted therapies (e.g., botulinum toxin injections) and non-pharmacological pain management integration [1][6].

2. Segment Insights

   • Skeletal muscle relaxants dominate the market (39% share in 2022), driven by demand for spasm relief in conditions like myositis and post-surgical recovery [16].
   • Tablets remain the preferred dosage form ($2 billion in 2022) due to precise dosing and stability [16].

3. Emerging Challenges

   • Drug-induced myopathy: Statins (e.g., atorvastatin), corticosteroids, and fluoroquinolones can cause muscle weakness, complicating long-term use [3][8].
   • Weight loss drugs: GLP-1 agonists (e.g., semaglutide) induce 25–39% muscle loss alongside fat reduction, raising concerns about sarcopenia risks [13].
   • NSAID interactions: High-dose ibuprofen inhibits muscle growth in young adults, affecting rehabilitation outcomes [14].

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Patent Landscape

Key Expirations & Generics

• Amrix (cyclobenzaprine HCl): Teva’s patent (US7387793) expires in February 2025, allowing generic entry. Seven other patents expired in 2023, accelerating competition [2][4].
• Modified-release formulations: Multiple patents (e.g., US7829121, US7790199) covering oral dosage forms have expired, broadening generic options [2].

Innovative Therapies & Patents

• New formulations:
  • Injectable methocarbamol: Patented for rapid action in acute spasm (US2976213A) [9].
  • Combination therapies: Cyclobenzaprine + diflunisal (IE49303B1) to address pain and inflammation synergistically [12].
• Biologics in development:
  • Bimagrumab (Novartis/MorphoSys): Anti-activin receptor antibody showing increased thigh muscle volume in trials [10].
  • Trevogrumab (Regeneron/Sanofi): Myostatin inhibitor in phase 2 for sarcopenia [10].

R&D Trends

• Personalized medicine: Focus on genetic factors influencing statin-induced myopathy [3][8].
• Non-opioid alternatives: Botulinum toxin and intrathecal baclofen gain traction for chronic spasticity [1][6].

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Competitive Outlook

• Leading players: Teva, Novartis, Regeneron, and Cephalon (now Viatris) dominate with brands like Amrix and Robaxin (methocarbamol) [2][4][9].
• Opportunities:
  • Generics: Post-2025, cyclobenzaprine generics will reduce costs but intensify pricing pressure [2].
  • Hybrid therapies: Combining myostatin inhibitors (e.g., trevogrumab) with exercise/nutrition for muscle wasting [10].

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Regulatory & Safety Considerations

• Monitoring requirements: FDA mandates vigilance for rhabdomyolysis linked to statins and antipsychotics [3][8].
• Dose optimization: Lowering doses of corticosteroids and NSAIDs mitigates myopathy risks without sacrificing efficacy [3][14].

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Conclusion

The striated muscle tone drug market is expanding due to demographic and therapeutic advances, but patent cliffs and safety concerns pose challenges. Innovations in biologics and combination therapies are critical for sustained growth, while generics will enhance accessibility post-2025.

References

1. https://www.thebusinessresearchcompany.com/market-insights/muscle-relaxant-drugs-market-overview-2025
2. https://pharsight.greyb.com/drug/amrix-patent-expiration
3. https://www.goodrx.com/drugs/side-effects/drug-induced-myopathy
4. https://casetext.com/analysis/in-re-cyclobenzaprine-hydrochlorine-extended-release-capsule-patent-litigation
5. https://www.jrheum.org/content/38/12/2653
6. https://www.researchnester.com/reports/muscle-relaxant-drugs-market/486
7. https://patents.justia.com/patents-by-us-classification/514/906
8. https://journals.physiology.org/doi/full/10.1152/physrev.00002.2019
9. https://patents.google.com/patent/US2976213A/en
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC7370765/
11. https://www.stifel.com/newsletters/investmentbanking/bal/marketing/healthcare/biopharma_timopler/stifelobesityupdate_july2024.pdf
12. https://patents.google.com/patent/IE49303B1/en
13. https://www.pbrc.edu/news/media/2024/skeletalmuscle.aspx
14. https://news.ki.se/anti-inflammatory-drugs-can-inhibit-muscle-growth
15. https://journals.physiology.org/doi/full/10.1152/ajpcell.00425.2021
16. https://www.gminsights.com/industry-analysis/muscle-relaxant-drugs-market