Muscle Relaxant Drug Class List

Drugs in Drug Class: Muscle Relaxant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sciegen Pharms Inc	CARISOPRODOL	carisoprodol	TABLET;ORAL	203374-001	Jan 27, 2014	AA	RX	No	No
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-002	Feb 1, 2007	AB	RX	Yes	Yes
Teva Pharms Intl	AMRIX	cyclobenzaprine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021777-001	Feb 1, 2007	AB	RX	Yes	No

Muscle Relaxant Market Analysis and Financial Projection

The muscle relaxant drugs market is experiencing significant growth driven by demographic and healthcare trends, while facing evolving patent challenges that shape competitive dynamics. Here's a detailed analysis:

Market Dynamics

Current Valuation & Projections

• The market size shows varied estimates due to different reporting methodologies:
  • $5.16 billion in 2025 (8.1% CAGR from $4.77B in 2024)[3]
  • $8.06 million by 2037 (6.9% CAGR from 2025)[1]
  • $5.91 billion by 2033 (4.24% CAGR from $3.90B in 2023)[5]

Key Growth Drivers

1. Aging Population: Over 1 billion people aged ≥60 globally, increasing demand for musculoskeletal treatments[1][5].
2. Chronic Conditions:
   • 570 million low back pain cases globally[1]
   • 527.8 million osteoarthritis cases (2019)[1]
   • Fibromyalgia affecting ~2% of US adults[1]
3. Lifestyle Factors: 81% of adolescents and 25% of adults insufficiently active, driving muscle weakness[1].

Market Challenges

• Restrictions on use during pregnancy and alcohol consumption[1]
• Side effects like liver dysfunction and respiratory issues[1][5]
• Short-term efficacy limiting chronic use[5]

Patent Landscape

Key Expiries & Generic Entry

Drug (Active Ingredient)	Patent Holder	Key Patent Expiry	Generic Launch Impact
Amrix (cyclobenzaprine)	Teva Pharmaceuticals	Feb 2025 (last patent)[2][4]	Generics expected post-2025 after 8 patents expired[2][10]
Bridion (sugammadex)	Merck	Jan 2026 (extended)[9]	Hikma filed Paragraph IV challenge in 2024, threatening earlier generic entry[11]

Critical Patent Disputes

• Amrix:

  • Federal Circuit upheld validity of '793/'372 patents (extended-release formulations) by emphasizing unique pharmacokinetic profiles[8][10].
  • Claims required specific drug release rates (e.g., ≤40% at 2 hours, 60–85% at 8 hours) and plasma concentration targets (Cₘₐₓ ~20 ng/mL)[8].

• Bridion:

  • Merck secured patent extension to 2026 via court ruling, but Hikma’s 2024 challenge could shorten exclusivity[9][11].

Emerging Trends

1. Advanced Formulations: Extended-release technologies (e.g., Amrix’s 24-hour efficacy)[8][10]
2. Targeted Therapies: Botulinum toxin adoption (+8.1% CAGR projected)[3]
3. Regional Expansion: Asia-Pacific fastest-growing market due to healthcare access improvements[5]

"The pharmacokinetic/pharmacodynamic relationship is critical in defending formulation patents" – Federal Circuit ruling on Amrix[8].

This landscape underscores how therapeutic innovation and legal strategies intertwine, with companies like Teva and Merck balancing R&D investments against generic competition risks. Market players are pivoting toward extended-release formulations and combination therapies to sustain growth amid patent cliffs[6][8].

References

1. https://www.researchnester.com/reports/muscle-relaxant-drugs-market/486
2. https://pharsight.greyb.com/drug/amrix-patent-expiration
3. https://www.thebusinessresearchcompany.com/market-insights/muscle-relaxant-drugs-market-overview-2025
4. https://pharsight.greyb.com/ingredient/cyclobenzaprine-hydrochloride-patent-expiration
5. https://www.sphericalinsights.com/reports/muscle-relaxant-drugs-market
6. https://www.polarismarketresearch.com/press-releases/muscle-relaxant-drugs-market
7. https://patents.google.com/patent/US2976213A/en
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/merck-secures-bridion-patent-protection-through-january-2026
10. https://casetext.com/analysis/in-re-cyclobenzaprine-hydrochlorine-extended-release-capsule-patent-litigation
11. https://www.biospace.com/merck-s-bridion-could-face-generic-pressure-from-hikma-ahead-of-patent-expiry-date