Last Updated: May 24, 2026

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.

  Start Trial

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
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Endo Operations ROBAXIN methocarbamol TABLET;ORAL 011011-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Endo Operations ROBAXIN-750 methocarbamol TABLET;ORAL 011011-006 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ROBAXIN (Methocarbamol) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ROBAXIN, the brand name for methocarbamol, is a muscle relaxant primarily prescribed for the short-term relief of muscle pain and spasms. Its market performance is driven by the prevalence of musculoskeletal disorders, the competitive landscape of muscle relaxants, and patent expirations affecting generic availability and pricing.

What is the Current Market Size and Growth Projection for ROBAXIN?

The global market for muscle relaxants, which includes methocarbamol, was valued at approximately $3.5 billion in 2023. This market is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2024 to 2030, reaching an estimated $4.7 billion by 2030. The growth is attributed to an aging global population, increasing incidence of sports injuries, and chronic pain conditions like back pain and fibromyalgia. ROBAXIN, as a well-established product, holds a significant share within this segment, although precise market share figures for the branded product are not publicly disclosed.

Factors Influencing Market Size and Growth

  • Prevalence of Musculoskeletal Disorders: Back pain, muscle strains, and spasms are common, driving demand for treatments like ROBAXIN. The World Health Organization (WHO) estimates that low back pain is the leading cause of disability worldwide. [1]
  • Aging Population: Older adults are more prone to degenerative conditions that can lead to muscle pain and spasms, increasing the patient pool for muscle relaxants.
  • Sports and Fitness Activities: An increase in sports participation and fitness-related injuries contributes to the demand for pain relief medications.
  • Availability of Generic Alternatives: The presence of multiple generic manufacturers for methocarbamol significantly impacts pricing and market share dynamics for the branded ROBAXIN.
  • Therapeutic Alternatives: The market is influenced by the availability and efficacy of other classes of pain relievers and muscle relaxants, including NSAIDs, opioids (though usage is declining due to safety concerns), and other centrally acting muscle relaxants.

What is the Intellectual Property Landscape for ROBAXIN?

The original patents for methocarbamol have long expired, leading to the widespread availability of generic versions. Original patents for methocarbamol (often as the active pharmaceutical ingredient or API) were filed in the late 1950s. The primary patent for the compound itself expired decades ago. Subsequent patent filings may relate to specific formulations, delivery methods, or manufacturing processes, but these have not sustained market exclusivity for the branded product.

Key Intellectual Property Milestones

  • Original Compound Patents: Expired in the mid-to-late 20th century.
  • Formulation Patents: Any existing patents for specific ROBAXIN formulations would have limited-term protection, typically 20 years from filing. Information on current, active formulation patents specifically for ROBAXIN brand is not readily available in public databases, suggesting no significant, blocking patents remain.
  • Generic Entry: The expiration of key patents allowed generic manufacturers to enter the market, increasing competition and driving down prices. The first generic versions of methocarbamol became available in the early 1990s.

Who are the Key Market Participants and Competitors?

The market for methocarbamol is characterized by the presence of the branded ROBAXIN (manufactured by Pfizer, Inc. in the U.S. as of recent information) and numerous generic manufacturers. Competition is primarily based on price and distribution networks.

Major Competitors and Their Offerings

  • Pfizer, Inc.: Manufacturer of branded ROBAXIN.
  • Generic Methocarbamol Manufacturers: A large number of pharmaceutical companies produce generic methocarbamol, including:
    • Teva Pharmaceutical Industries Ltd.
    • Mylan N.V. (now Viatris Inc.)
    • Sun Pharmaceutical Industries Ltd.
    • Cipla Ltd.
    • Accord Healthcare Inc.
    • Aurobindo Pharma Ltd.
  • Other Muscle Relaxant Products: While not direct methocarbamol competitors, other muscle relaxants compete for the same patient indications. These include:
    • Cyclobenzaprine (e.g., Flexeril, Amrix)
    • Carisoprodol (e.g., Soma)
    • Baclofen (e.g., Lioresal)
    • Tizanidine (e.g., Zanaflex)

What is the Financial Performance and Pricing Strategy of ROBAXIN?

The financial performance of branded ROBAXIN is subject to significant pressure from generic competition. Pricing strategies for branded drugs in a post-patent environment focus on maintaining brand loyalty, perceived quality, and market access through formulary placements.

Pricing and Revenue Trends

  • Branded vs. Generic Pricing: Branded ROBAXIN typically commands a premium price compared to its generic counterparts. However, this premium has eroded considerably since the advent of generic competition. Average wholesale prices for branded ROBAXIN can be 5-10 times higher than generic methocarbamol.
  • Revenue Decline: Revenue for branded ROBAXIN has likely declined steadily over the past two decades due to generic erosion. Exact revenue figures for ROBAXIN are not publicly reported by Pfizer as a standalone product but are aggregated within their broader product portfolios.
  • Market Share: Branded ROBAXIN's market share has diminished as healthcare providers and payers opt for lower-cost generic alternatives. Its market share is likely concentrated in situations where brand preference or specific contractual agreements persist.
  • Cost of Goods Sold (COGS): Branded products often have higher COGS due to marketing, distribution, and R&D recoupment (though R&D for ROBAXIN is historical). Generic manufacturers operate with lower overheads, enabling competitive pricing.

Pricing Strategy for Branded ROBAXIN

  • Value-Based Messaging: Emphasizing consistent quality, reliability, and established efficacy compared to variable generic quality.
  • Payer Contracts: Negotiating formulary placement with insurance providers to ensure patient access, often involving rebates.
  • Physician Engagement: Maintaining relationships with healthcare providers through medical science liaisons and educational programs.

What are the Regulatory Considerations and Market Access Challenges?

ROBAXIN and its generic equivalents are subject to regulatory oversight by bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Market access is influenced by drug pricing, formulary inclusion, and prescribing guidelines.

Regulatory and Market Access Factors

  • FDA Approval: Methocarbamol is approved by the FDA for the management of pain and discomfort associated with acute, painful musculoskeletal conditions. Generic versions must demonstrate bioequivalence to the branded product.
  • Prescribing Guidelines: Guidelines from professional medical organizations can influence the prescribing patterns of muscle relaxants, potentially favoring certain agents over others based on efficacy and safety profiles.
  • Payer Policies: Insurance companies' formularies and prior authorization requirements significantly impact which muscle relaxants are covered and at what cost-sharing level for patients. This directly affects uptake and market share.
  • Drug Utilization Review (DUR): Payer-driven DUR programs monitor prescribing patterns for muscle relaxants to ensure appropriate use and control costs, potentially flagging excessive or long-term use of any muscle relaxant.
  • Safety Concerns: Like all muscle relaxants, methocarbamol carries potential side effects, including drowsiness and dizziness, which can influence prescribing decisions and patient adherence.

What are the Future Market Trends and Opportunities for ROBAXIN?

The future for branded ROBAXIN is largely constrained by its generic status. Opportunities lie in niche markets or through potential strategic partnerships, rather than new product development.

Potential Future Trajectories

  • Continued Generic Dominance: The market is expected to remain dominated by generic methocarbamol due to cost-effectiveness.
  • Niche Market Preservation: Branded ROBAXIN might retain a small market share among patients or physicians with strong brand loyalty or in specific healthcare systems.
  • Combination Therapies: While not currently a significant trend for ROBAXIN, future research could explore its use in combination with other pain management modalities, though this would likely require new patentable formulations or indications, which is improbable for an established API.
  • Geographic Expansion (Generics): Generic methocarbamol manufacturers may continue to expand into emerging markets as healthcare infrastructure improves and demand for affordable pain relief grows. Branded ROBAXIN's presence in these markets would be limited.
  • Focus on Lifecycle Management: For the brand owner (Pfizer), strategies may shift to optimizing its position within their portfolio, potentially divesting the brand if its revenue contribution becomes negligible, or focusing solely on managing its decline.

Key Takeaways

  • Branded ROBAXIN (methocarbamol) operates in a mature market for muscle relaxants heavily influenced by widespread generic availability.
  • The original compound patents for methocarbamol expired decades ago, enabling significant generic competition.
  • The global muscle relaxant market is projected to grow, driven by an aging population and the prevalence of musculoskeletal disorders, but this growth benefits generic methocarbamol more than the branded product.
  • Pricing for branded ROBAXIN is under constant pressure from lower-cost generic alternatives, impacting its revenue trajectory.
  • Market access for ROBAXIN is largely determined by payer formularies and physician prescribing habits, which increasingly favor generics.
  • Future opportunities for branded ROBAXIN are limited, with generic versions expected to continue dominating the market.

Frequently Asked Questions

  1. What is the primary indication for ROBAXIN? ROBAXIN is indicated for the short-term relief of discomfort associated with acute, painful musculoskeletal conditions.

  2. Has ROBAXIN’s patent protection expired? Yes, the primary patents covering the methocarbamol compound expired decades ago, allowing for generic manufacturing.

  3. How does the price of branded ROBAXIN compare to generic methocarbamol? Branded ROBAXIN is priced at a premium, but generic methocarbamol is significantly less expensive, often by a factor of five to ten.

  4. Which companies are major competitors to branded ROBAXIN? Numerous generic pharmaceutical manufacturers, including Teva, Viatris, and Sun Pharma, compete with branded ROBAXIN. Other muscle relaxants like cyclobenzaprine and carisoprodol also represent therapeutic competition.

  5. What is the projected growth rate for the overall muscle relaxant market? The global muscle relaxant market is projected to grow at a CAGR of 4.2% from 2024 to 2030.


Citations

[1] World Health Organization. (n.d.). Low back pain. Retrieved from https://www.who.int/news-room/fact-sheets/detail/low-back-pain

More… ↓

⤷  Start Trial

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.