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Last Updated: March 26, 2026

ASPIRIN; MEPROBAMATE - Generic Drug Details


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What are the generic drug sources for aspirin; meprobamate and what is the scope of freedom to operate?

Aspirin; meprobamate is the generic ingredient in five branded drugs marketed by Sun Pharm Industries, Sandoz, Par Pharm, Medpointe Pharm Hlc, and Quantum Pharmics, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ASPIRIN; MEPROBAMATE
US Patents:0
Tradenames:5
Applicants:5
NDAs:5
DailyMed Link:ASPIRIN; MEPROBAMATE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for ASPIRIN; MEPROBAMATE

US Patents and Regulatory Information for ASPIRIN; MEPROBAMATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries EQUAGESIC aspirin; meprobamate TABLET;ORAL 011702-003 Dec 29, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Medpointe Pharm Hlc MICRAININ aspirin; meprobamate TABLET;ORAL 084978-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Quantum Pharmics Q-GESIC aspirin; meprobamate TABLET;ORAL 088740-001 Jun 1, 1984 DISCN No 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

ASPIRIN; MEPROBAMATE Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Aspirin and Meprobamate?

Aspirin remains a global over-the-counter analgesic and anti-inflammatory drug, with annual sales estimated at approximately $2 billion. It faces a mature market marked by established brand loyalty, but growth is constrained by patent expirations and increasing generic competition. Aspirin's primary demand drivers include cardiovascular disease prevention, pain management, and anti-inflammatory applications. Public health campaigns and evolving guidelines on its use for primary prevention of heart attacks have impacted sales slightly, but it continues to maintain a significant market share globally.

Meprobamate, by contrast, has experienced a decline in widespread use since the 1980s. Its primary application as an anxiolytic has been eclipsed by newer benzodiazepines and SSRIs. Annual sales are negligible relative to aspirin, with limited availability mostly in generic form and in select markets. Its market trajectory is predominantly downward, driven by safety concerns and regulatory restrictions.

How Do the Market Structures Differ?

Aspirin:

  • Market Size: Estimated at $2–3 billion worldwide.
  • Market Type: Mature, highly competitive with multiple global manufacturers.
  • Pricing: Price erosion due to generic entry; still accessible over-the-counter.
  • Patents: Expired; no innovative patent protection since 1980s.
  • Regulation: Well-established, with global health agencies endorsing its safety and efficacy.

Meprobamate:

  • Market Size: Minimal, with sales mostly in legacy markets.
  • Market Type: Niche, with limited demand.
  • Pricing: Low, primarily generic.
  • Patents: Expired decades ago.
  • Regulation: Subject to restrictions; concerns over dependency and adverse effects limit its use.

What Is the Financial Trajectory?

Aspirin:

  • Revenue remains steady, with slight oscillations based on public health recommendations.
  • Market growth is limited to low single-digit percentages annually.
  • Strategic variations focus on new formulations (e.g., extended-release) and combination products.
  • Regulatory advises caution in primary prevention settings, potentially reducing future growth.

Meprobamate:

  • Declining to negligible levels.
  • Commercial viability limited; many manufacturers have exited the market.
  • Future sales are expected to dwindle, with minimal investment or innovation.

How Do External Factors Influence Market Trajectories?

Regulatory landscape:
Stringent safety assessments for over-the-counter analgesics influence aspirin's market stability. For meprobamate, increased regulation and safety concerns about dependency restrict availability.

Public health policies:
Promotion of low-dose aspirin for cardiovascular prevention sustains demand, despite the controversy over its risk-benefit profile for certain populations. Conversely, no new indications support meprobamate's continued use.

Patent and innovation:
Aspirin's patent expired decades ago. However, patenting new formulations or combination therapies could offer niche growth. Meprobamate has no recent patent activity, limiting potential for market revival.

Competitive environment:
Multiple generics suppress prices and margins for aspirin. The entry of newer drugs like paracetamol or NSAIDs further dilutes its market share. Meprobamate faces no significant new competition but also a shrinking customer base.

What Are the Key Takeaways?

  • Aspirin remains a stable, though mature, market driven by cardiovascular and pain management uses. Its revenues are stabilized but constrained by evolving clinical guidelines and generic competition.

  • Meprobamate's market has largely evaporated due to safety issues and competition from newer benzodiazepines and antidepressants. No significant growth or innovation is foreseeable.

  • External factors like regulation, public health policies, and patent expirations have a direct impact on the market size and growth potential for both drugs.

  • Investment in aspirin-related innovation (e.g., combination therapies or new formulations) could yield marginal growth, but the overall outlook for aspirin remains conservative.

Five FAQs

1. Is there potential for new formulations of aspirin to influence its market?
Yes. Extended-release formulations or combination therapies may open niche markets, especially for chronic pain or cardiovascular risk reduction. However, such innovations face regulatory hurdles and market acceptance challenges.

2. What safety concerns limit aspirin's broader use?
Gastrointestinal bleeding, bleeding risk, and aspirin-exacerbated respiratory disease (AERD) restrict its use, especially in primary prevention among certain populations.

3. Why did meprobamate decline in popularity?
Safety concerns, including dependency and adverse effects, led to regulatory restrictions. The availability of safer anxiolytics reduced its clinical relevance.

4. Are patents relevant to aspirin's market?
Aspirin's patent expired in 1980. Current market positioning relies on brand recognition and established safety profiles rather than patent protection.

5. What is the outlook for aspirin in emerging markets?
Potential remains in countries with less saturated markets and where cardiovascular disease prevalence is rising. Regulatory and affordability factors will influence growth.


References:

  1. Statista. "Aspirin global sales." 2022.
  2. FDA. "Aspirin label information." 2021.
  3. IMS Health. "Market analysis for NSAIDs." 2021.
  4. European Medicines Agency. "Safety review of meprobamate." 2019.
  5. WHO. "Cardiovascular Disease Prevention." 2020.

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