Aspirin - Generic Drug Details

What are the generic sources for aspirin and what is the scope of patent protection?

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, Novitium 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, Glenmark Speclt, Micro Labs, Ph Health, Sun Pharm, Zydus Pharms, Schwarz Pharma, Abbott, Par Pharm, Medpointe Pharm Hlc, Mcneil, Robins Ah, Genus Lifesciences, Actavis Labs Fl Inc, Epic Pharma Llc, Endo Operations, 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. There is one tentative approval for this compound.

Summary for aspirin

International Patents:	20
US Patents:	6
Tradenames:	53
Applicants:	59
NDAs:	89
Drug Master File Entries:	22
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	1,742
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

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
Stanford University	PHASE2
University of Cincinnati	PHASE3
Stanford University	PHASE3

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.

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
Ivax Sub Teva Pharms	PROPOXYPHENE COMPOUND 65	aspirin; caffeine; propoxyphene hydrochloride	CAPSULE;ORAL	083077-002	Dec 7, 1984		DISCN	No	No
Sun Pharm Industries	EQUAGESIC	aspirin; meprobamate	TABLET;ORAL	011702-003	Dec 29, 1983		DISCN	No	No
Dr Reddys Labs Sa	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	203335-001	Oct 30, 2015		DISCN	No	No
Meda Pharms	SOMA COMPOUND	aspirin; carisoprodol	TABLET;ORAL	012365-005	Jul 11, 1983		DISCN	No	No

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
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013

International Patents for aspirin

Country	Patent Number	Title	Estimated Expiration
South Korea	20200008032
South Korea	20140105436	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)
European Patent Office	2760433

Supplementary Protection Certificates for aspirin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

ASPIRIN: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What does “ASPIRIN” mean in market terms?

“ASPIRIN” is an older small-molecule drug (acetylsalicylic acid, ASA) sold as an analgesic and antipyretic and, at low doses, as an antiplatelet. In market dynamics, it behaves like a mature, multi-manufacturer, low-priced over-the-counter (OTC) and generic commodity with periodic shifts driven by:

• Patent expiry and generic entry decades ago (most markets are long past exclusivity).
• Formulation and brand competition in OTC channels (strength, dosing form, coatings, combination products).
• Regulatory and reimbursement regimes for low-dose antiplatelet use (where applicable by country).
• Demand resilience tied to chronic cardiovascular prevention and seasonal illness patterns.

How is the market structured for aspirin (supply, products, and channels)?

Aspirin’s market is split primarily by drug role and formulation:

Product role

• OTC acute care: headache, fever, minor aches and pains.
• Low-dose antiplatelet: secondary prevention and certain primary prevention regimes depending on jurisdiction and clinical guidance.

Formulation and packaging

Aspirin is sold in multiple dosage forms and strengths, typically including:

• Immediate release tablets
• Enteric-coated tablets
• Effervescent or dispersible forms
• Combination products (common in some OTC geographies, but market reporting often aggregates by active ingredient)

Channel dynamics

• OTC retail: price competition, shelf visibility, and brand loyalty matter more than clinical differentiation.
• Institutional and tender markets: tend to drive generic price compression.
• Pharmacy distribution: largely depends on local stocking patterns, brand switching, and reimbursement lists.

What market dynamics move pricing and volume?

1) Generic oversupply keeps ASPIRIN’s “innovation premium” near zero

With most markets long cleared of exclusivity, price is dominated by:

• Bulk purchasing and tender awards
• Manufacturer scale advantages
• Competitive contracting among generics

This leads to stable but structurally low margins for manufacturers selling commoditized ASA.

2) Brand competition shifts demand within the commodity

Where brands exist (OTC), they influence:

• Repeat purchase frequency (habit-based switching)
• Pack size and dosing convenience
• Safety perception tied to enteric-coating and GI tolerance narratives

These factors can move volume share even if ASPIRIN’s unit price stays compressed.

3) Clinical guidance drives low-dose antiplatelet utilization waves

Utilization of low-dose aspirin depends on evolving guideline positions on primary prevention versus secondary prevention. These shifts can move:

• Patient adherence patterns
• Prescriber preference (where low-dose aspirin competes with alternative antiplatelet regimens)
• Market demand for enteric-coated versus immediate-release SKUs

4) Safety and risk management affects uptake

Aspirin’s GI bleeding and hemorrhagic risk influences market demand through:

• Labeling and patient selection
• Uptake of alternatives in higher-risk cohorts
• Substitution toward other antiplatelets in certain segments

This effect is typically gradual and guidance-driven rather than sudden.

5) Seasonal demand supports OTC volume but not long-term pricing

Aspirin’s antipyretic and analgesic positioning produces:

• Winter and cold-season uplift for acute OTC demand
• Temporary inventory build patterns
• Minimal long-term price changes due to commodity supply structure

How does the financial trajectory usually look for aspirin?

Aspirin’s financial profile is defined by “mature commodity behavior” rather than growth-led valuation metrics:

Revenue trajectory

• Long-run trend: relatively flat to modest growth, driven by population and baseline cardiovascular and acute-care demand.
• Short-run variation: seasonal OTC swings and guideline-driven changes in low-dose utilization.
• Net effect: revenue can remain stable even as unit economics compress.

Margin trajectory

• Unit price pressure: persistent due to multi-source generic supply.
• Mix-driven margin protection: achievable only through higher-value formulations (enteric-coated, effervescent) and brand/OTC positioning.
• Profit structure: tends to shift from “brand premium” to “volume scale and manufacturing cost control.”

Cash flow and capital allocation

In mature aspirin markets:

• Producers prioritize capacity utilization and supply continuity.
• Capex is oriented around manufacturing efficiency, packaging automation, and compliance rather than new clinical differentiation.
• Working capital dynamics follow retail/institutional ordering cycles.

What would investors or R&D buyers look for in aspirin’s “financial trajectory” metrics?

For ASPIRIN, the most actionable metrics are operational and mix-based rather than innovation metrics:

Manufacturer-level indicators

• Gross margin trend (compressed by generic competition, occasionally buoyed by formulation/brand mix)
• Volume growth vs. price decline split (volume can rise even when average selling price falls)
• Production cost per batch and yields (drives sustainability in low-margin pricing)
• Regional share changes in OTC versus tender/institutional channels

Channel-level indicators

• Retail share shifts among OTC brands and store brands
• Tender awarded prices and contract duration stability in hospital and bulk purchasing
• Switching resistance from coating/convenience claims (mix effect more than pricing power)

How does aspirin compare with typical branded vs. generic drug trajectories?

Below is the standard “shape” for aspirin versus a typical branded product and a typical generic entrant:

Dimension	ASPIRIN (mature commodity)	Branded innovator (typical)	Generic entrant (typical)
Pricing power	Low	Higher early, erodes with competition	Drops sharply on entry, may stabilize
Revenue growth	Flat to modest	Often grows with differentiation	Often grows fast initially, then compresses
Margin	Structurally constrained	Higher early; falls post-competition	Lower; driven by scale and cost
Main drivers	Formulation mix, OTC branding, guidance	Clinical differentiation, payer coverage	Tender wins, bioequivalence supply reliability
Risk profile	Supply and regulatory compliance, price pressure	Clinical, safety, patent/IP	Price erosion and low-margin competition

What are the practical market outlook drivers for aspirin going forward?

1) Continued generic competition and substitution

Aspirin’s market likely stays competitive:

• Multiple suppliers reduce price spikes risk but also cap upside
• Substitution toward other antiplatelets may limit segment growth in some jurisdictions

2) Formulation and patient preference

Premiumization within the commodity is most plausible through:

• Enteric-coated acceptance in GI-sensitive cohorts
• Convenience dosing formats
• Packaging that aligns with consumer purchasing behavior

3) Regulatory and reimbursement stability for antiplatelet use

Outcomes hinge on whether clinical guidelines and payer policies reinforce:

• Secondary prevention use as a steady demand anchor
• Primary prevention restraint as a limiter to expansion

4) Competitive pressure from alternative therapies

In the cardiovascular prevention segment, aspirin competes indirectly with:

• Other antiplatelet agents
• Anticoagulant strategies in specific populations (depending on indication and risk profile)

These dynamics usually pressure incremental demand but do not remove the base consumption that secondary prevention sustains.

What is the “financial trajectory” implication for business strategy?

For manufacturers and commercial buyers, aspirin economics usually reward:

• Cost leadership (raw materials, process efficiency, yields)
• Manufacturing capacity assurance (continuity in supply tends to win contracts)
• Mix management through formulation and pack strategy
• Channel-specific execution (OTC branding and retail share tactics differ from tender winning)

For R&D, aspirin is not typically a “new molecular entity” investment case. Value creation is more common through:

• Line extensions (formulation changes)
• Combination products where allowed and commercially viable
• Manufacturing and quality system improvements that reduce cost and regulatory risk

Key Takeaways

• ASPIRIN functions as a mature, multi-source commodity where pricing is structurally constrained by generic competition and tender dynamics.
• Demand is stable in the long run, supported by baseline cardiovascular antiplatelet use and resilient OTC acute-care consumption, with seasonal OTC volume swings.
• Margin trajectory is driven by cost control and product mix (enteric-coated and convenience formats), not by innovation-led pricing.
• Future upside is more likely to come from operational excellence and mix shifts than from market expansion driven by new clinical differentiation.

FAQs

1) Is aspirin’s market primarily OTC or prescription?
Aspirin is both, but the supply chain and consumer purchasing dynamics are heavily influenced by OTC sales while low-dose antiplatelet usage drives a separate steady demand component depending on local clinical guidance and reimbursement rules.

2) What most affects aspirin pricing?
Generic multi-sourcing and bulk purchasing/tender pricing. Even when OTC branding exists, average pricing power remains limited.

3) Does aspirin revenue grow faster than inflation?
Typically no. Revenue tends to track modest growth with population and utilization, while average unit prices trend downward or remain flat due to competition.

4) Can manufacturers protect margins in aspirin?
Yes, primarily through manufacturing cost leadership and mix management toward higher-value formulations (for example, enteric-coated or convenience formats).

5) What is the biggest medium-term demand risk?
Shifts in clinical guidance and payer policies that reduce or re-segment aspirin use in primary prevention or increase substitution to alternative antiplatelet therapies in certain risk groups.

References

[1] WHO Model List of Essential Medicines. World Health Organization. https://www.who.int/teams/health-product-and-policy-standards/essential-medicines (accessed 2026-04-24).
[2] European Medicines Agency (EMA). Aspirin-related information and product classification resources. https://www.ema.europa.eu/ (accessed 2026-04-24).
[3] U.S. Food and Drug Administration (FDA). Acetylsalicylic acid product labeling and OTC/OTC monographs context. https://www.fda.gov/ (accessed 2026-04-24).
[4] World Health Organization. Antiplatelet and cardiovascular risk guidance materials (contextual background for aspirin use patterns). https://www.who.int/ (accessed 2026-04-24).