You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 30, 2025

ROBAXIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Robaxin, and when can generic versions of Robaxin launch?

Robaxin is a drug marketed by Hikma and Endo Operations and is included in two NDAs.

The generic ingredient in ROBAXIN is methocarbamol. There are twenty-seven drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the methocarbamol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Robaxin

A generic version of ROBAXIN was approved as methocarbamol by REGCON HOLDINGS on July 21st, 2017.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ROBAXIN?
  • What are the global sales for ROBAXIN?
  • What is Average Wholesale Price for ROBAXIN?
Summary for ROBAXIN
Drug patent expirations by year for ROBAXIN
Drug Prices for ROBAXIN

See drug prices for ROBAXIN

Recent Clinical Trials for ROBAXIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mayo ClinicPhase 4
Medical College of WisconsinPhase 4

See all ROBAXIN clinical trials

Pharmacology for ROBAXIN

US Patents and Regulatory Information for ROBAXIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma ROBAXIN methocarbamol SOLUTION;IM-IV 011790-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Endo Operations ROBAXIN methocarbamol TABLET;ORAL 011011-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Endo Operations ROBAXIN-750 methocarbamol TABLET;ORAL 011011-006 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ROBAXIN

Last updated: August 1, 2025

Introduction

Robaxin (generic: methocarbamol) is a central nervous system (CNS) muscle relaxant approved primarily for treating acute musculoskeletal conditions such as strains, sprains, and muscle spasticity. Its marketed presence has persisted for decades, positioning it within a competitive landscape of muscle relaxants and analgesics. Analyzing its market dynamics and financial trajectory requires understanding its pharmacological profile, regulatory status, competitive environment, and the broader healthcare trends influencing demand and profitability.

Pharmacological Profile and Therapeutic Use

Robaxin's mechanism involves central muscle relaxation through sedation, reducing muscle spasms. It is often prescribed alone or adjunctively with analgesics like NSAIDs. Notably, it has a well-established safety profile, which sustains its use in outpatient settings. Despite its long-standing market presence, it faces challenges from newer agents offering broader therapeutic benefits or improved safety profiles.

Regulatory and Patent Landscape

Robaxin, originally developed by Novartis and now off-patent, is available as a generic medication, which significantly impacts its pricing and market exclusivity. The expiration of patents in the early 2000s facilitated widespread generic adoption, leading to lower prices but also constraining potential revenue growth for branded producers. Current patent protections no longer provide market exclusivity, increasing competition from generic manufacturers and reducing profitability margins.

Market Size and Demand Drivers

Globally, muscle relaxant medications constitute a modest segment within the broader CNS and pain management markets. In the United States, the market for muscle relaxants was valued at approximately USD 400-500 million as of the early 2020s, with Robaxin representing a significant share given its longstanding presence [1]. The demand for Robaxin correlates with the prevalence of musculoskeletal disorders, which are among the leading causes of disability worldwide, especially as populations age and sedentary lifestyles persist.

The rise in outpatient, primary care, and emergency room prescriptions sustains steady demand. However, shifts toward multimodal pain management, increased focus on opioid-sparing strategies, and the development of newer agents have exerted downward pressure on Robaxin's market share.

Competitive Landscape

Robaxin faces intense competition from both generic muscle relaxants and alternative therapies. Notable competitors include:

  • Cyclobenzaprine (Flexeril): Market leader with extensive prescribing prevalence.
  • Methocarbamol generics: Many manufacturers offer low-cost versions.
  • Other agents: Carisoprodol, tizanidine, baclofen—each with specific advantages and concerns.

The generic market's dominance constrains pricing, while clinical trends favor drugs with improved safety profiles. For example, cyclobenzaprine's sedative effects and potential interactions can limit its use, but it maintains a greater market share due to medical familiarity.

Financial Trajectory Analysis

Given Robaxin's patent expiry and the shift to generics, its revenue growth is primarily driven by volume rather than price. Sales figures exhibit stability but limited growth potential. The primary revenue driver in recent years is consistent demand within primary care settings, with minor fluctuations attributable to shifts in clinical guidelines and prescribing habits.

Research and development investments have been minimal for Robaxin, reflecting its generic status and mature market profile. The focus for pharmaceutical companies has shifted towards innovative pain management therapeutics, biosimilars, and targeted CNS agents. Consequently, Robaxin’s financial trajectory is characterized by:

  • Revenue Stability: Steady sales due to institutional prescribing and chronic musculoskeletal condition prevalence.
  • Limited Growth Potential: Saturation in developed markets and fierce competition prevent significant expansion.
  • Margin Pressure: Low prices owing to generic competition diminish profit margins.
  • Potential Off-Label and Combination Uses: Occasional off-label prescribing or combination therapies could influence demand modestly but lack robust growth prospects.

Emerging Trends Impacting Robaxin

Several trends influence Robaxin’s market dynamics:

  • Shift Toward Multimodal Pain Management: Emphasizing non-opioid, non-sedative agents reduces reliance on traditional muscle relaxants.
  • Patient-Centered Care: Increase in patient safety priorities restricts use of sedative or CNS depressant drugs, potentially limiting Robaxin's application.
  • Technological Advances: New biologic and small-molecule therapies target underlying musculoskeletal pathology, indirectly reducing demand for symptomatic treatments like Robaxin.
  • Regulatory Influences: Focus on safety and efficacy, including antimicrobial stewardship and opioid-sparing initiatives, shape formulary decisions.

Future Outlook

The outlook for Robaxin remains conservative. Revenue growth predominantly hinges on steady prescription volumes in primary care, aging populations, and the management of musculoskeletal injuries. However, without new formulations, indications, or significant patent protections, substantial revenue expansion is unlikely.

Pharmaceutical companies might pursue niche formulations or combination products to extend the brand's lifecycle but face limited incentives due to the mature market status. Moreover, increased healthcare provider and patient emphasis on minimizing sedation and CNS depressant use further temper demand.

Key Market Segments and Geographic Considerations

  • United States: The largest market with established prescribing patterns; generic competition suppresses margins.
  • Europe & Asia: Growing awareness of musculoskeletal disorders and aging populations support modest demand, but regulatory and reimbursement differences impact sales strategies.
  • Emerging Markets: Expanding healthcare infrastructure may drive increased consumption of affordable generics like Robaxin but are constrained by local pricing and competition.

Conclusion

Robaxin’s market and financial trajectory are emblematic of mature, generic drugs within the CNS therapeutic category. Its stable demand contrasts with limited growth prospects due to patent expiry, intense generic competition, and evolving clinical practices favoring alternative therapies. While current revenue streams remain reliable, innovative repositioning or combination formulations could be necessary for systemic growth. Overall, Robaxin’s future hinges on market stability rather than expansion.


Key Takeaways

  • Robaxin's revenue stability relies on its established safety profile and modest demand rooted in musculoskeletal disorders.
  • The absence of patent protection and fierce generic competition limit its profitability and growth potential.
  • Market shifts toward multimodal pain therapies and safety concerns restrain demand growth.
  • Geographic diversification offers limited opportunities due to market maturity and pricing pressures.
  • Sustained demand for generic muscle relaxants suggests continued relevance but requires strategic innovation for significant revenue uplift.

Frequently Asked Questions (FAQs)

1. How does Robaxin compare to newer muscle relaxants in terms of safety and efficacy?
Robaxin generally exhibits a favorable safety profile, with fewer sedative effects compared to agents like cyclobenzaprine. However, newer agents may offer targeted mechanisms or fewer CNS effects, influencing prescriber preferences.

2. What factors could alter Robaxin’s market share in the future?
Emerging preferences for non-sedative alternatives, regulatory focus on CNS depressants, and innovations in musculoskeletal pain management could reduce Robaxin's market share.

3. Is there potential for Robaxin to reclaim patent protections or develop new formulations?
Currently unlikely, as the franchise is well established as a generic medication with little recent developmental activity. Any innovative formulations would require significant investment with uncertain returns.

4. How does the competitive landscape influence Robaxin’s pricing?
Generic competition exerts substantial downward pressure on prices, favoring volume over margins, limiting profitability for manufacturers.

5. What role do emerging markets play in Robaxin’s long-term outlook?
Growing healthcare access and aging populations in emerging markets could sustain demand, but low-cost generics from local manufacturers and regulatory hurdles pose challenges.


References

[1] Market research data on muscle relaxant market valuation and prescription trends, 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.