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Last Updated: December 14, 2025

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE - Generic Drug Details


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

Aspirin; caffeine; propoxyphene hydrochloride is the generic ingredient in six branded drugs marketed by Alra, Xanodyne Pharm, Ivax Sub Teva Pharms, Sandoz, Teva, and Watson Labs, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE
US Patents:0
Tradenames:6
Applicants:6
NDAs:7
DailyMed Link:ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE at DailyMed

US Patents and Regulatory Information for ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xanodyne Pharm DARVON COMPOUND-65 aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 010996-007 Mar 8, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ivax Sub Teva Pharms PROPOXYPHENE COMPOUND 65 aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 083077-002 Dec 7, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 085732-002 Sep 3, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sandoz PROPOXYPHENE COMPOUND-65 aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 083101-002 Jun 24, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sandoz PROPOXYPHENE COMPOUND 65 aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 080044-002 Sep 16, 1983 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 Aspirin, Caffeine, and Propoxyphene Hydrochloride

Last updated: July 30, 2025

Introduction

Understanding the market dynamics and financial trajectory of pharmaceuticals such as aspirin, caffeine, and propoxyphene hydrochloride is crucial for stakeholders in healthcare, investment, and regulatory sectors. These compounds, each with distinct therapeutic profiles, regulatory histories, and market influences, provide a comprehensive picture of the evolving pharmaceutical landscape.


Aspirin: An Enduring Staple in Cardiovascular and Pain Management

Market Dynamics

Aspirin (acetylsalicylic acid) remains one of the most widely used over-the-counter (OTC) medications globally. Its primary indications include analgesic, antipyretic, anti-inflammatory, and antiplatelet uses. The drug's proven efficacy in secondary prevention of cardiovascular events has sustained its demand, although recent debates regarding its primary prevention role have influenced prescribing practices [1].

The regulatory environment has evolved, with many countries issuing updated guidelines on aspirin's use, especially concerning primary prevention in low-risk populations. Additionally, the rise of personalized medicine and risk stratification algorithms shape market strategies.

Market competition is intense, with generic manufacturers dominating due to patent expirations dating back decades. Innovatively, some companies explore novel formulations—such as low-dose or enteric-coated tablets—to maintain patient compliance and reduce gastrointestinal side effects.

Financial Trajectory

The global aspirin market was valued at approximately USD 1.3 billion in 2020 and is projected to experience modest growth, with a compound annual growth rate (CAGR) of roughly 2% over the next five years [2]. The mature status of the drug limits rapid revenue expansion but offers stable cash flows.

Emerging markets provide growth opportunities driven by increased healthcare access and aging populations. However, regulatory restrictions in certain regions—aimed at mitigating overuse or addressing bleeding risks—could temper sales growth.

The transition of aspirin from prescription to OTC use in many jurisdictions enhances accessibility but constrains pricing power. Companies focus on margins through cost efficiencies and packaging innovations.


Caffeine: A Psychostimulant with Expanding Applications

Market Dynamics

Caffeine’s role extends beyond household consumption; it is crucial in functional beverages, dietary supplements, and certain medications. Its stimulant properties are harnessed for improving alertness, cognitive performance, and physical endurance.

The expanding functional foods segment, fueled by aging populations and rising health awareness, propels caffeine demand. The global caffeine market was valued at around USD 3.3 billion in 2021, with projections reaching USD 4.35 billion by 2028 at a CAGR of approximately 4.2% [3].

Despite its popularity, regulatory oversight varies. Concerns about excessive intake—especially among adolescents and sensitive populations—prompt regulatory scrutiny, leading to warnings and restrictions in some regions.

Financial Trajectory

The caffeine market benefits from diversification across industries, especially with the growth of energy drinks and supplement markets. Innovation continues with encapsulated, decaffeinated, and controlled-release formulations aimed at health-conscious consumers.

Major players, including BASF and Tata Chemicals, have expanded production capacities to meet rising demand. Executives forecast steady growth fueled by product innovation, expanding application portfolios, and emerging markets.

Nevertheless, the market faces challenges around negative health perceptions linked to overconsumption. This could temper growth prospects and influence regulatory tightening, leading to more stringent labeling and usage guidelines.


Propoxyphene Hydrochloride: A Cautionary Tale with Declining Market Presence

Market Dynamics

Propoxyphene hydrochloride, once widely employed as an analgesic and antitussive, experienced declining usage following safety concerns. Its popularity peaked in the 1970s but waned rapidly after studies linked it with increased risk of cardiac toxicity and fatalities, especially in overdose situations [4].

Regulatory agencies, including the U.S. Food and Drug Administration (FDA), issued safety warnings, culminating in the voluntary withdrawal of marketed formulations in 2010. The decision was driven by data indicating an elevated risk of cardiac arrhythmias and overdose-related deaths.

In response, pharmaceutical companies rapidly exited the market, and no new formulations have appeared. The drug’s decline exemplifies how safety concerns can diminish market viability even for longstanding drugs.

Financial Trajectory

The propoxyphene market has fundamentally collapsed, with minimal to no revenue generation since the withdrawal. The compound is no longer commercially available in many jurisdictions, and liabilities related to adverse events have led to legal actions and financial losses for manufacturers.

The subdued market reduces the relevance of profitability metrics. However, legacy issues—such as legal claims or ongoing liability settlements—may impose financial burdens on remaining stakeholders and insurers.

Overall, propoxyphene's trajectory underscores the critical importance of post-market safety surveillance and the swift regulatory response to emerging risks.


Conclusion

The market dynamics and financial trajectories for aspirin, caffeine, and propoxyphene hydrochloride reflect a spectrum of regulatory, safety, and consumer preference trends. Aspirin maintains its position through stable demand and incremental innovations, despite changing guidelines. Caffeine benefits from expanding applications in functional foods but faces regulatory scrutiny over health risks. Propoxyphene exemplifies how safety concerns can abruptly terminate a drug's market presence, leading to economic decline for stakeholders.

Understanding these patterns enables industry participants, investors, and policymakers to anticipate shifts, allocate resources effectively, and ensure consumer safety.


Key Takeaways

  • Aspirin’s stability stems from its long-standing efficacy and established market presence, with moderate growth driven by new formulations and emerging markets.
  • Caffeine’s expanding footprint in functional foods and supplements positions it for sustained growth, but regulatory and health concerns could influence its trajectory.
  • Propoxyphene illustrates the market risks associated with safety issues; its decline emphasizes the importance of rigorous safety monitoring and swift regulatory action.
  • Regulatory landscapes play a pivotal role in shaping market dynamics, often superseding patent lifecycles in influence.
  • Innovation and safety are critical for sustained profitability; drugs sidestepping these principles risk obsolescence or market withdrawal.

FAQs

  1. What factors influence the ongoing demand for aspirin?
    Demand is driven by its proven efficacy in cardiovascular disease prevention, pain management, and anti-inflammatory use. Market trends also depend on evolving clinical guidelines, safety considerations, and formulary restrictions.

  2. How does caffeine's rising popularity impact health regulations?
    Increased consumption leads to regulatory scrutiny over safe dosage levels, especially in energy drinks and dietary supplements. Authorities may impose labeling requirements or restrictions to mitigate health risks.

  3. Why was propoxyphene withdrawn from the market?
    Safety concerns related to cardiac toxicity and overdose risks led to FDA warnings and voluntary market withdrawal in 2010, ending its role in pain management.

  4. What opportunities exist for growth in the caffeine market?
    Innovation in delivery forms, expansion of functional health products, and increasing global demand—particularly in emerging markets—offer growth avenues.

  5. What lessons can be learned from propoxyphene’s market exit?
    The importance of rigorous post-market safety surveillance, transparency, and swift regulatory response is highlighted. Long-term profitability depends on safety, efficacy, and consumer trust.


References

[1] National Institutes of Health. Aspirin (NSAID) Facts. https://www.ninds.nih.gov (Accessed 2023).

[2] Research and Markets. Global Aspirin Market Analysis. 2021.

[3] Grand View Research. Caffeine Market Size & Trends. 2022.

[4] U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA approves label changes for aspirin and other NSAIDs. 2013.

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