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Last Updated: December 11, 2025

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quantum Pharmics Q-GESIC aspirin; meprobamate TABLET;ORAL 088740-001 Jun 1, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Par Pharm MEPROBAMATE AND ASPIRIN aspirin; meprobamate TABLET;ORAL 089126-001 Aug 19, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sandoz MEPRO-ASPIRIN aspirin; meprobamate TABLET;ORAL 089127-001 Mar 2, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Medpointe Pharm Hlc MICRAININ aspirin; meprobamate TABLET;ORAL 084978-001 Approved Prior to Jan 1, 1982 DISCN No 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 Drugs: Aspirin and Meprobamate

Last updated: July 30, 2025


Introduction

The pharmaceutical landscape is profoundly shaped by the evolving market dynamics surrounding established drugs like aspirin and meprobamate. Both possess distinct historical significance—aspirin as a cornerstone of analgesic therapy, and meprobamate as an anxiolytic agent—yet they face divergent regulatory, commercial, and technological challenges. Understanding their current market trajectories requires an in-depth analysis of demographic trends, regulatory shifts, patent statuses, competition, and innovation pipelines.


Aspirin: Market Dynamics and Financial Trajectory

Historical Context and Current Usage

Aspirin (acetylsalicylic acid), developed in the late 19th century, remains a globally recognized non-steroidal anti-inflammatory drug (NSAID). Its versatile applications encompass pain relief, anti-inflammatory effects, and cardiovascular prophylaxis. Despite the advent of newer agents, aspirin's low cost, extensive safety profile, and broad availability sustain its sales, especially for secondary prevention in cardiovascular disease.

Global Demand and Market Drivers

The aspirin market's momentum stems primarily from its role in preventing myocardial infarction and stroke, particularly among aging populations. According to market research firm GlobalData, the global aspirin market was valued at approx. USD 1.8 billion in 2022 and is projected to grow modestly at a compound annual growth rate (CAGR) of around 3% over the next five years.

In high-income countries, aspirin's demand is steady, bolstered by established treatment protocols and extensive clinical guidelines. Meanwhile, emerging markets are witnessing increased access and adoption, driven by expanding healthcare infrastructure and rising cardiovascular disease prevalence.

Regulatory Environment and Patent Considerations

While aspirin's patent expired decades ago—placing it firmly in the generic domain—regulatory decisions influence its market dynamics. For instance, recent guidelines by the U.S. Preventive Services Task Force (USPSTF) have refined recommendations on aspirin use for primary prevention, favoring individualized risk assessments, which could temper volume growth.

The absence of patent protection results in intense price competition among generic manufacturers. Moreover, regulatory agencies such as the FDA require clear labeling and quality standards, but no significant barriers exist to entry, leading to market saturation and pricing pressures.

Emerging Trends and Innovations

While innovations in aspirin formulation—such as controlled release or combination therapies—are ongoing, they have yet to significantly alter the core market. Notably, research ongoing into aspirin’s potential cancer preventive effects may open new therapeutic vistas, although these remain investigational and are unlikely to immediately impact sales.

Financial Outlook

Aspirin’s stable market position suggests moderate growth prospects primarily sustained by aging demographics and ongoing secondary prevention use. However, the intense price competition, evolving guidelines, and clear regulatory positioning mean that profit margins are under pressure. Pharmaceutical companies may focus on developing value-added formulations or exploring new indications to sustain revenue streams.


Meprobamate: Market Dynamics and Financial Trajectory

Historical Background and Decline

Meprobamate, introduced in the 1950s as an anxiolytic, initially gained popularity as a non-benzodiazepine anxiolytic agent. Its market dominance was short-lived, primarily due to safety concerns—particularly dependence, withdrawal, and sedation—and the advent of benzodiazepines in the 1960s, which offered better safety profiles.

Current Market and Regulatory Status

Today, meprobamate's presence in the pharmaceutical landscape is negligible. The FDA deprecated its use owing to safety issues; in the U.S., it was classified as a controlled substance and later removed from the market. Globally, its usage is minimal, restricted mostly to specific local markets with less stringent regulations.

Market research indicates a negligible global demand for meprobamate, with sales confined to limited regions where it persists as a repurposed or deprecated class of treatment.

Patents, Competition, and Barriers to Entry

Given its age, meprobamate's original patents long expired. Because of safety concerns, it faces extensive regulatory hurdles and declining prescriber confidence, effectively eliminating commercial viability. The market is effectively non-existent in developed countries, replaced by benzodiazepines and newer anxiolytics with improved safety profiles.

Innovation and Future Prospects

There is minimal ongoing research or innovation regarding meprobamate. Its pharmacological profile and adverse effect profile make it an unlikely candidate for re-emergence in modern therapy. Regulatory bans and widespread societal recognition of its risks secure its obsolescence.

Financial Trajectory

The financial outlook for meprobamate is bleak. Market presence is virtually nonexistent, and ongoing liability concerns pose further barriers. Any residual sales are from legacy formulations or unregulated markets, offering negligible or negative growth prospects.


Comparison and Contrasting Market Trajectories

While aspirin maintains a steady, if slow-growing, market driven by widespread clinical guidelines, aging populations, and expanding markets in developing economies, meprobamate’s trajectory is toward obsolescence driven by safety concerns, regulatory bans, and the dominance of safer alternatives.

The long-term outlook for aspirin appears stable with potential modest growth, contingent on clinical validation for ancillary indications like cancer prevention. Conversely, meprobamate's market future is virtually non-existent, with its legacy entrenched more in the realm of pharmaceutical history and regulatory control than commercial viability.


Regulatory and Technological Influences

Regulatory policies remain pivotal for both drugs. For aspirin, evolving guidelines necessitate ongoing monitoring and potential repositioning strategies if new indications emerge. For meprobamate, tight regulation and historical safety issues cement its declining trajectory.

Technological advances, such as targeted drug delivery systems, personalized medicine, and biomarker-driven treatment, could enhance aspirin's future applications, further stabilizing its market. In contrast, the pharmacovigilance landscape diminishes the likelihood of meprobamate's market re-emergence.


Key Takeaways

  • Aspirin's enduring demand is driven by its proven cardiovascular benefits, low cost, and extensive clinical use. Market growth will likely remain modest but steady, with opportunities for innovation in new indications and formulations.

  • Regulatory guidelines critically influence aspirin’s market stability; aligning clinical evidence with evolving protocols remains essential for sustained commercial success.

  • Market challenges include pricing pressures due to generic competition and the need to demonstrate value in preventive care strategies amid changing healthcare policies.

  • Meprobamate's market future is virtually non-existent due to safety issues and regulatory restrictions, with negligible commercial prospects. Its historical significance offers limited commercial value going forward.

  • Regulatory and safety considerations are central to market trajectories, emphasizing the importance of post-market surveillance and drug repositioning efforts for established drugs.


FAQs

1. Is aspirin expected to face significant patent challenges in the future?
No. Aspirin's patents expired over a century ago; its market is dominated by generics. Future challenges will predominantly stem from regulatory guideline changes and clinical evidence rather than patent issues.

2. Can aspirin’s potential new uses boost its market significantly?
Potentially. Ongoing research into aspirin's role in cancer prevention and other indications may open new markets. However, clinical validation and regulatory approval are prerequisites for commercial expansion.

3. Why has meprobamate become obsolete in most markets?
Due to its adverse effect profile, including dependence and sedation risks, coupled with the superior safety profiles of benzodiazepines, regulatory agencies have restricted or banned meprobamate, leading to its obsolescence.

4. What strategies can pharmaceutical companies employ to extend aspirin’s market life?
Investing in novel formulations, exploring new clinical indications, and integrating aspirin into combination therapies can sustain its relevance amidst evolving treatment paradigms.

5. How do regulatory changes impact the commercial viability of old drugs like aspirin and meprobamate?
Regulatory updates can either reinforce market stability, through reaffirmation of safety and efficacy, or impose restrictions that diminish market size. For aspirin, evolving guidelines influence prescribing patterns; for meprobamate, regulatory bans effectively eliminate its market.


References

[1] GlobalData. "Aspirin Market Analysis," 2022.
[2] U.S. Preventive Services Task Force. "Aspirin in Primary Prevention," 2022.
[3] Food and Drug Administration (FDA). "Drug Approvals and Regulatory Agencies," 2023.
[4] MarketWatch. "Over-the-Counter (OTC) Drugs Market," 2022.
[5] WHO. "Global Burden of Cardiovascular Diseases," 2021.

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