Physiological Effect: Decreased Striated Muscle Contraction

Drugs with Physiological Effect: Decreased Striated Muscle Contraction

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Elite Labs Inc	DANTROLENE SODIUM	dantrolene sodium	CAPSULE;ORAL	076686-001	Oct 24, 2005	AB	RX	No	No
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 Contraction Market Analysis and Financial Projection

The market for drugs that decrease striated muscle contraction—including skeletal muscle relaxants and neuromuscular blocking agents—is experiencing robust growth, driven by aging populations, chronic musculoskeletal conditions, and advancements in targeted therapies. Meanwhile, the patent landscape reflects a mix of expired blockbusters, active litigation, and innovative formulations extending market exclusivity. Below is a detailed analysis:

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Market Dynamics

• Growth Trajectory:
  The global muscle relaxant drugs market is projected to grow from $4.77 billion in 2024 to $7.05 billion by 2029, at an 8.1% CAGR [2][11]. Key drivers include:

  • Rising geriatric populations prone to muscle spasms and chronic pain [2][14].
  • Increased surgical procedures requiring neuromuscular blockers like rocuronium and vecuronium [3][9].
  • Expansion of non-pharmacological pain management integrating muscle relaxants [11].

• Market Segmentation:

  • Drug Types: Skeletal muscle relaxants (e.g., methocarbamol, cyclobenzaprine) dominate, while neuromuscular blockers (e.g., sugammadex) show rapid adoption [2][4].
  • Formulations: Oral and injectable routes lead, with extended-release formulations (e.g., Amrix®) gaining traction due to patent-protected PK/PD profiles [7][17].
  • Key Players: Merck’s Bridion ($487M Q1 2023 sales) exemplifies growth in reversal agents for neuromuscular blockade [9].

• Regional and Therapeutic Trends:

  • Demand surges in regions with aging demographics, such as North America and Europe [14].
  • Botulinum toxin injections emerge as alternatives for focal spasticity [2].

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Patent Landscape

• Expired Patents and Generics:

  • Methocarbamol: Once protected under US2976213A (expired), it now faces generic competition with 62 suppliers and 105 API vendors [12].
  • Cyclobenzaprine: Original patents expired, but extended-release formulations (e.g., Amrix®) retain exclusivity through pharmacokinetic patents (US7,387,793) until 2024–2028 [7][17].

• Active Patent Strategies:

  • Merck’s Bridion: Patent term extensions secured through January 2026 after litigation affirmed regulatory review period calculations [9].
  • Non-Sedative Innovations: Emerging patents target reduced side effects, e.g., EDG-5506 (small-molecule inhibitor of fast skeletal muscle contraction) [13].

• Litigation and Exclusivity:

  • Courts increasingly uphold formulation patents (e.g., cyclobenzaprine’s Tmax and AUC parameters) [17].
  • The "patent cliff" eroded $67B from pharma revenues (2007–2012), pushing firms toward lifecycle management for muscle relaxants [5].

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Emerging Trends

1. Personalized Medicine:
   Pharmacogenomic approaches optimize dosing for aging populations, reducing adverse effects [2][13].
2. Biomechanical Targets:
   Drugs like MG53 enhance membrane repair in dystrophic muscles, while TRIM72 analogs enter preclinical trials [8][13].
3. Non-Opioid Demand:
   With 10% of adults managing chronic pain, non-addictive relaxants (e.g., tizanidine) gain priority [2][12].

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Case Study: Bridion (Sugammadex)

Merck’s Bridion, a cyclodextrin-based reversal agent, exemplifies market and patent synergy:

• 2022 Sales: $1.7B, driven by surgical volume and ICU use [9].
• Patent Lifespan: Extended to 2026 via judicial rulings, delaying generics [3][9].

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Future Outlook

• R&D Focus: Small molecules improving sarcomere function (e.g., troponin modifiers) and gene therapies for inherited myopathies [13][15].
• Regulatory Pressures: Stricter safety profiles for older drugs (e.g., carisoprodol’s abuse potential) may reshape prescription trends [12].

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"The preparation [of methocarbamol] has been found useful in acute muscle spasm involving the lumbosacral area, posterior neck, and deltoid hip muscles." [1]

This combination of market expansion and strategic IP management underscores a sector poised for innovation, albeit challenged by generics and evolving therapeutic paradigms.

References

1. https://patents.google.com/patent/US2976213A/en
2. https://www.thebusinessresearchcompany.com/report/muscle-relaxant-drugs-global-market-report
3. https://www.thepharmaletter.com/pharmaceutical/court-rules-in-favor-of-merck-in-patent-case
4. https://www.openpr.com/news/3869354/neuromuscular-blocking-drug-market-poised-for-5-1-growth-set
5. https://www.uspharmacist.com/article/drug-patent-expirations-and-the-patent-cliff
6. https://rupress.org/jgp/article/136/1/21/53230/Regulation-of-contraction-in-mammalian-striated
7. https://casetext.com/analysis/in-re-cyclobenzaprine-hydrochlorine-extended-release-capsule-patent-litigation
8. https://journals.biologists.com/dmm/article/17/6/dmm050487/341220/Physiological-stress-improves-stem-cell-modeling
9. https://www.biospace.com/merck-secures-bridion-patent-protection-through-january-2026
10. https://patents.google.com/patent/US20190046614A1/en
11. https://www.thebusinessresearchcompany.com/market-insights/muscle-relaxant-drugs-market-overview-2025
12. https://www.drugpatentwatch.com/p/generic/methocarbamol
13. https://pmc.ncbi.nlm.nih.gov/articles/PMC10281779/
14. https://www.giiresearch.com/report/tbrc1659259-muscle-relaxant-drugs-global-market-report.html
15. https://bioe.uw.edu/unveiling-solutions-the-vital-role-of-uw-center-for-translational-muscle-research-in-addressing-skeletal-muscle-dysfunction/
16. https://patents.justia.com/patent/5190924
17. https://caselaw.findlaw.com/court/us-federal-circuit/1608878.html
18. https://casetext.com/case/in-re-cyclobenzaprine-hydrochloride-extended-release