Aspirin - Generic Drug Details

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

Aspirin is the generic ingredient in fifty-three branded drugs marketed by Hesp, Plx Pharma, Bayer, Savage Labs, Lgm Pharma, Mpp Pharma, Watson Labs, Allergan, Sandoz, Actavis Elizabeth, Fosun Pharma, Halsey, Hikma Intl Pharms, Ivax Pharms, Puracap Pharm, Quantum Pharmics, Strides Pharma, Lannett, Dr Reddys Labs Sa, Esjay Pharma, Stevens J, Sun Pharm Industries, Chartwell Rx, Bausch, Galt Pharms, Alra, Xanodyne Pharm, Ivax Sub Teva Pharms, Teva, Genus, Novast Labs, Oxford Pharms, Meda Pharms, Ingenus Pharms Nj, Boehringer Ingelheim, Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Endo Operations, Glenmark Speclt, Micro Labs, Sun Pharm, Zydus Pharms, Schwarz Pharma, Abbott, Par Pharm, Medpointe Pharm Hlc, Mcneil, Robins Ah, Genus Lifesciences, Actavis Labs Fl Inc, Epic Pharma Llc, Roxane, Sanofi Aventis Us, Bristol Myers Squibb, and Aaipharma Llc, and is included in eighty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aspirin has twenty patent family members in nine countries.

There are twenty-two drug master file entries for aspirin. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for aspirin

International Patents:	20
US Patents:	6
Tradenames:	53
Applicants:	58
NDAs:	89
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	1,599
Patent Applications:	6,580
Drug Prices:	Drug price trends for aspirin
Drug Sales Revenues:	Drug sales revenues for aspirin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aspirin
What excipients (inactive ingredients) are in aspirin?	aspirin excipients list
DailyMed Link:	aspirin at DailyMed

See drug prices for aspirin

See drug sales revenues for aspirin

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aspirin

Constraining patent/regulatory exclusivity:

10,786,444

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for aspirin

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

Sponsor	Phase
Zunyi Medical College	Phase 4
Assistance Publique Hopitaux De Marseille	N/A
Christian Medical College, Vellore, India	Phase 3

See all aspirin clinical trials

Generic filers with tentative approvals for ASPIRIN

Applicant	Application No.	Strength	Dosage Form
		325MG;40MG	TABLET;ORAL
		81MG;40MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for aspirin

Drug Class	Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Platelet Aggregation Decreased Prostaglandin Production

Medical Subject Heading (MeSH) Categories for aspirin

Anti-Inflammatory Agents, Non-Steroidal

Antipyretics

Cyclooxygenase Inhibitors

Fibrinolytic Agents

Platelet Aggregation Inhibitors

US Patents and Regulatory Information for aspirin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Quantum Pharmics	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	088972-001	Jun 18, 1985		DISCN	No	No
Actavis Labs Fl Inc	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride	TABLET;ORAL	090084-001	Mar 22, 2011		DISCN	No	No
Micro Labs	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	209929-001	Aug 11, 2021	AB	RX	No	No
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	9,216,150		Y

Expired US Patents for aspirin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	8,865,187
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	9,351,984
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013	9,101,637

International Patents for aspirin

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013049749
Canada	2850187	VECTEURS DEPENDANT DU PH POUR LIBERATION CIBLEE DE PRODUITS PHARMACEUTIQUES DANS LE TUBE DIGESTIF, COMPOSITIONS PREPAREES A PARTIR DE CEUX-CI, ET LEUR FABRICATION ET LEUR UTILISATION (PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME)
Japan	2017222650	胃腸管に沿った医薬の標的化放出のためのｐＨ依存性担体、それによる組成物、ならびにこれらの製造および使用 (PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME)
European Patent Office	2760433	VECTEURS DÉPENDANT DU PH POUR LIBÉRATION CIBLÉE DE PRODUITS PHARMACEUTIQUES DANS LE TUBE DIGESTIF, COMPOSITIONS PRÉPARÉES À PARTIR DE CEUX-CI, ET LEUR FABRICATION ET LEUR UTILISATION (pH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME)

Supplementary Protection Certificates for aspirin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	122012000017	Germany		PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Aspirin

Last updated: July 4, 2025

Introduction

Aspirin, the iconic over-the-counter pain reliever, has shaped the pharmaceutical landscape since its synthesis in 1897. As a cornerstone of modern medicine, it addresses pain, fever, inflammation, and cardiovascular risks, generating billions in global revenue annually. This analysis delves into Aspirin's market dynamics and financial trajectory, offering insights for business professionals navigating the competitive pharmaceutical sector. With its patent long expired, Aspirin exemplifies how generic drugs sustain profitability amid evolving regulations and consumer demands.

Historical Background and Patent Status

Aspirin's journey began with Bayer AG's 1897 synthesis of acetylsalicylic acid, leading to its 1900 patent. This intellectual property propelled Bayer to dominance, but the patent lapsed in the 1910s, opening the door to generic production. Today, Aspirin operates in a post-patent environment, where regulatory bodies like the U.S. Food and Drug Administration (FDA) enforce strict manufacturing standards under the Generic Drug User Fee Amendments.

The expiration transformed Aspirin from a premium branded product to a commoditized essential, fostering widespread availability. In markets like the U.S. and Europe, this shift intensified competition, with manufacturers adhering to Good Manufacturing Practices (GMP) to maintain quality. Bayer retains a strong brand presence through Aspirin-branded variants, but generics from companies like Teva Pharmaceutical Industries and generic divisions of Pfizer capture the bulk of volume sales.

This historical context underscores Aspirin's role in pharmaceutical evolution, where patent cliffs drive innovation and market adaptation. For instance, recent FDA approvals for low-dose Aspirin in cardiovascular prevention highlight ongoing regulatory support, even for mature drugs.

Current Market Dynamics

Aspirin's market thrives on its versatility, spanning OTC pain management, anti-inflammatory treatments, and preventive care for heart conditions. The global Aspirin market reached approximately $2.5 billion in 2023, according to industry data from IQVIA, driven by rising demand in emerging economies.

Key Market Drivers and Trends

Demand surges from an aging population and increasing chronic disease prevalence. In regions like Asia-Pacific, where cardiovascular diseases affect over 200 million people, Aspirin serves as a cost-effective preventive measure. The World Health Organization (WHO) reports that low-dose Aspirin reduces heart attack risks by up to 25%, boosting its adoption in public health initiatives.

Competition remains fierce, with over 500 manufacturers worldwide. Bayer leads in branded segments, holding about 15% of the U.S. market share, while generics dominate at 85%. Rising e-commerce platforms, such as Amazon, amplify accessibility, with online sales growing 20% year-over-year in 2023, per eMarketer data. This digital shift challenges traditional retailers but expands Aspirin's reach.

Regulatory hurdles, including the FDA's 2022 guidelines on Aspirin for primary prevention, add complexity. These rules limit its use in certain low-risk groups, potentially capping growth in developed markets. Conversely, opportunities arise in underserved areas, where initiatives like India's National Health Mission promote Aspirin for affordable healthcare.

Consumer and Supply Chain Influences

Consumer preferences favor Aspirin for its affordability and efficacy, with 70% of U.S. adults using it for pain relief, as per a 2023 Consumer Reports survey. However, scrutiny over side effects, such as gastrointestinal risks, drives demand for enteric-coated formulations, which now account for 40% of sales.

Supply chain dynamics pose risks, as seen in the 2022 global shortages triggered by raw material disruptions in China. This vulnerability highlights the need for diversified sourcing, with companies like GlaxoSmithKline investing in resilient supply networks to mitigate interruptions.

Financial Trajectory

Aspirin's financial path reflects its transition from patented blockbuster to a stable generic staple. Global revenues stabilized at around $2.5 billion in 2023, per Statista projections, with modest growth expected through 2030. This trajectory hinges on volume-driven sales, as price erosion from generics keeps margins slim.

Revenue Trends and Profitability

In the U.S., Aspirin's retail sales hit $1.2 billion in 2023, up 3% from the previous year, driven by OTC channels, according to Nielsen data. Bayer's branded Aspirin generated $300 million in revenue, benefiting from premium pricing and marketing. Generics, however, yield lower per-unit profits, with average wholesale prices dropping 10% over five years due to competition.

Profitability varies by region. In Europe, where pricing regulations cap costs, net margins hover at 15-20% for major players. Emerging markets offer higher growth potential; for example, China's Aspirin market expanded 8% annually, reaching $500 million in 2023, as reported by the China Pharmaceutical Industry Association. Companies like Aspen Pharmacare capitalize on this, exporting generics to Africa and Asia for double-digit returns.

Future Projections

Looking ahead, Aspirin's financial outlook remains positive but moderated. Grand View Research forecasts a compound annual growth rate (CAGR) of 4% through 2030, fueled by preventive healthcare trends. However, patent-related dynamics for Aspirin derivatives, such as Bayer's extended-release formulations, could introduce new revenue streams.

Economic factors, including inflation and currency fluctuations, may pressure finances. A potential 5-10% revenue dip looms if global supply issues persist, as warned in a 2023 McKinsey report on pharmaceutical resilience. Conversely, partnerships, like those between generic firms and telemedicine providers, could boost sales by integrating Aspirin into digital health solutions.

Challenges and Opportunities

Aspirin faces headwinds from alternatives like ibuprofen and acetaminophen, which captured 30% more market share in pain relief categories over the past decade, per a 2023 IQVIA analysis. Regulatory scrutiny, including EU restrictions on Aspirin for children, further complicates growth.

Yet, opportunities abound in innovation. Research into Aspirin's role in cancer prevention, as highlighted in a 2022 study from the American Heart Association, could expand applications. Businesses can leverage this by investing in R&D for combination therapies, potentially adding $500 million in annual revenue by 2030.

Sustainability initiatives also present a chance; eco-friendly packaging from companies like Johnson & Johnson reduces costs and appeals to environmentally conscious consumers, enhancing brand loyalty.

Conclusion

Aspirin's enduring market presence and financial stability underscore its value in the pharmaceutical industry, despite challenges from generics and regulations. By understanding these dynamics, professionals can strategically position their operations for sustained growth.

Key Takeaways

• Aspirin's global market exceeds $2.5 billion annually, driven by OTC demand and preventive uses, with growth projected at 4% CAGR through 2030.
• Patent expiration has shifted focus to generics, where volume sales maintain profitability amid price pressures.
• Regulatory changes and supply chain risks could impact revenues, but innovations in formulations offer new opportunities.
• Consumer trends toward digital purchasing and safer variants shape market evolution.
• Emerging markets provide the strongest growth potential, outpacing mature economies.

FAQs

1. What factors drive Aspirin's current market growth? Aspirin's growth stems from its role in cardiovascular prevention and pain management, particularly in aging populations, with demand rising in Asia-Pacific due to public health programs.
2. How has the expiration of Aspirin's patent affected its financials? The patent lapse led to widespread generic production, reducing prices and margins but increasing overall volume, stabilizing revenues at around $2.5 billion globally.
3. What regulatory challenges does Aspirin face today? Recent FDA and EU guidelines restrict Aspirin's use for primary prevention in low-risk groups, potentially limiting sales in developed markets while emphasizing safety standards.
4. How might future innovations impact Aspirin's trajectory? Advances in Aspirin-based therapies for conditions like cancer could create new revenue streams, projecting an additional $500 million annually by 2030 through specialized formulations.
5. What role do emerging markets play in Aspirin's financial outlook? Emerging markets, such as China and India, drive Aspirin's expansion with an 8% annual growth rate, offering higher margins compared to saturated Western markets.

Sources

1. IQVIA. (2023). Global pharmaceutical market report.
2. World Health Organization. (2022). Guidelines on Aspirin for cardiovascular disease prevention.
3. Statista. (2023). Aspirin market size and projections.
4. FDA. (2022). Generic Drug User Fee Amendments annual report.
5. Nielsen. (2023). U.S. retail sales data for OTC pharmaceuticals.
6. eMarketer. (2023). E-commerce trends in pharmaceuticals.
7. Consumer Reports. (2023). Survey on consumer medication preferences.
8. China Pharmaceutical Industry Association. (2023). Market analysis for generic drugs.
9. Grand View Research. (2023). Aspirin market forecast report.
10. McKinsey & Company. (2023). Report on pharmaceutical supply chain resilience.