Aspirin; dipyridamole - Generic Drug Details

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

Aspirin; dipyridamole is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Glenmark Speclt, Micro Labs, Ph Health, Sandoz, Sun Pharm, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound.

Summary for aspirin; dipyridamole

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	25
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aspirin; dipyridamole
DailyMed Link:	aspirin; dipyridamole at DailyMed

Recent Clinical Trials for aspirin; dipyridamole

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

Sponsor	Phase
Rutgers, The State University of New Jersey	Phase 3
Ministry of Health, France	Phase 3
University Hospital, Lille	Phase 3

See all aspirin; dipyridamole clinical trials

Pharmacology for aspirin; dipyridamole

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

Anatomical Therapeutic Chemical (ATC) Classes for aspirin; dipyridamole

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for ASPIRIN; DIPYRIDAMOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AGGRENOX	Extended-release Capsules	aspirin; dipyridamole	25 mg and 200 mg	020884	1	2007-02-01

US Patents and Regulatory Information for aspirin; dipyridamole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	208572-001	Aug 21, 2018		DISCN	No	No
Micro Labs	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	209929-001	Aug 11, 2021	AB	RX	No	No
Boehringer Ingelheim	AGGRENOX	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	020884-001	Nov 22, 1999		DISCN	Yes	No
Sandoz	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	206739-001	Jan 18, 2017	AB	RX	No	No

Expired US Patents for aspirin; dipyridamole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	AGGRENOX	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	020884-001	Nov 22, 1999

Market Dynamics and Financial Trajectory for Aspirin and Dipyridamole

Last updated: July 27, 2025

Introduction

Aspirin (acetylsalicylic acid) and dipyridamole are notable pharmaceuticals widely employed in cardiovascular disease management. Aspirin’s established role as an antiplatelet agent for preventing heart attack and stroke contrasts with dipyridamole’s supplementary use alongside aspirin for secondary stroke prevention. This analysis examines the market dynamics, competitive landscape, regulatory environment, and financial trajectory shaping these drugs' future investments and commercialization potentials.

---

Market Overview

Aspirin: A Pillar in Cardiovascular Therapy

Aspirin remains one of the most consumed over-the-counter (OTC) medications worldwide, with a history spanning over a century. Its primary mechanism—irreversible inhibition of cyclooxygenase enzymes—reduces thromboxane A2, impeding platelet aggregation. According to the World Health Organization (WHO), aspirin plays a critical role in preventive cardiology, especially in secondary prevention of ischemic events [1].

Despite its age, aspirin’s global market is projected to sustain steady growth, driven by aging populations, increasing cardiovascular disease (CVD) prevalence, and expanding indications. The global aspirin market size was valued at approximately USD 1.2 billion in 2022, with a compound annual growth rate (CAGR) of roughly 3.5% forecasted through 2030 [2].

Dipyridamole: Niche with Potential Growth

Dipyridamole, a phosphodiesterase inhibitor with vasodilatory and antiplatelet properties, is less broadly utilized but remains critical in combination therapies—particularly with aspirin for secondary stroke prevention. Its market is comparatively smaller, estimated at USD 150 million in 2022, yet poised for growth due to clinical guideline endorsements and new formulation development.

---

Market Drivers

1. Aging Population and CVD Burden

   The demographic shift toward older populations globally accelerates demand for antiplatelet therapy. Aging populations in North America, Europe, and Asia amplify the need for both primary and secondary prevention strategies [3].

2. Expanding Indications and Preventive Strategies

   Advances in clinical guidelines favor aspirin use in primary prevention for high-risk individuals, while dipyridamole's role in combination therapy sustains niche demand.

3. Generic Penetration and Cost Accessibility

   Aspirin’s affordability and availability as an OTC drug ensure widespread usage, reinforcing its dominant market share. Patent expirations have contributed to price reductions but maintained volume-driven revenue.

4. Emerging Markets Adoption

   Growth opportunities in India, China, and Southeast Asia stem from improved healthcare infrastructure and rising awareness about cardiovascular health.

---

Market Constraints and Challenges

Safety Concerns and Regulatory Shifts

• Bleeding Risks: Aspirin’s association with gastrointestinal bleeding limits its use in certain populations. Regulatory agencies such as the FDA and EMA have issued guidelines cautioning against indiscriminate use, especially for primary prevention in low-risk individuals [4].

• Revised Indications: Increasing emphasis on individualized therapy and risk stratification challenges the broad application of aspirin, potentially constraining market growth.

Dipyridamole-specific Challenges

• Limited Commercial Brand Presence: Dipyridamole’s existing formulations face competition from other antiplatelets, and lack of distinct branding limits expansion.

• Perception of Lower Efficacy: Clinicians often prefer newer agents with improved efficacy or safety profiles, such as clopidogrel or ticagrelor.

---

Regulatory and Patent Landscape

• Patent Expirations and Generics

  Aspirin’s patent expired decades ago, leading to a robust generic market. Dipyridamole faced patent expiry earlier, resulting in commoditized pricing [5].

• New Formulations and Combination Drugs

  Innovative combinations, such as aspirin with dipyridamole (aggrenox), have secured regulatory approval for specific indications, potentially driving future revenues.

• Regulatory Environment

  Regulatory authorities emphasize evidence-based use, with ongoing surveillance of safety profiles influencing prescription trends. The rise of "preventive" indications fosters regulatory scrutiny but also opens pathways for label expansions.

---

Financial Trajectory and Investment Outlook

Aspirin: Stable, Mature Market

• Revenue Trends

  The global aspirin market is expected to grow modestly (~3.5% CAGR through 2030) driven predominantly by volume rather than price increases. The OTC segment continues to be a significant revenue stream, although sales are increasingly influenced by regulatory restrictions on primary prevention.

• Innovation and Differentiation

  Limited innovation persists; focus is shifting toward formulations that optimize safety and patient compliance, such as enteric-coated tablets or combination drugs.

Dipyridamole: Niche Growth Potential

• Market Expansion

  As secondary stroke prevention gains emphasis and guidelines endorse combination therapy, dipyridamole accesses a potentially expanding market. New formulations or delivery systems (e.g., sustained-release or IV preparations) could rejuvenate interest.

• Investment Opportunities

  Innovative drug delivery, combination therapies, and targeted indications present avenues for biotech and pharma investments. However, the relatively small market size necessitates strategic positioning.

Future Outlook

The overall financial trajectory shows stability for aspirin, with incremental growth driven by demographic and epidemiological factors. Dipyridamole, while niche, offers growth potential through clinical practice shifts and formulation innovations. The primary uncertainties remain regulatory constraints due to safety concerns and competition from newer anticoagulants and antiplatelets, impacting long-term revenue projections.

---

Competitive and Strategic Considerations

• Emerging Alternatives

  The rise of P2Y12 inhibitors like clopidogrel and newer agents with improved safety profiles challenge aspirin’s dominance in certain indications.

• Generic Market Dynamics

  The expiration of patents implies that volume and market share, rather than pricing power, will be critical for revenue streams.

• Potential for Biosimilars and OTC Conversion

  For aspirin, OTC availability and biosimilar proliferation affirm broad access, though certain markets limit OTC status due to safety concerns.

---

Conclusion

Aspirin’s market remains mature but vital, supported by broad usage and demographic trends, albeit facing safety-driven regulatory constraints. Dipyridamole's niche status and specialized utility position it as a candidate for growth through formulation innovations and guideline-driven adoption. Overall, the financial prospects for both drugs hinge on balancing safety concerns, regulatory environments, and innovation pathways that enhance efficacy and compliance.

---

Key Takeaways

• Aspirin dominates the anti-thrombotic market with steady growth driven by aging and CVD prevalence, but faces regulatory and safety-related hurdles.
• Dipyridamole’s niche role in secondary stroke prevention offers growth opportunities through formulation improvements and guideline endorsements.
• Patent expirations and generics have stabilized revenues but limit pricing power; innovation is key to future value.
• Emerging markets provide growth avenues, supported by improving healthcare infrastructure and increasing awareness.
• The competitive landscape is evolving with newer antiplatelet agents; strategic positioning requires leveraging formulations, combination therapies, and personalized medicine.

---

FAQs

1. How will regulatory changes impact aspirin's market share in primary prevention?
Regulatory agencies have become more cautious regarding aspirin in primary prevention due to bleeding risks, leading to stricter guidelines that limit its use in low-risk populations. This shift is expected to slow overall growth but reinforce its role in secondary prevention, maintaining its core market.

2. Are there new formulations of dipyridamole in development?
Yes, ongoing research focuses on sustained-release formulations, combination drugs, and alternative delivery systems to improve compliance and efficacy, potentially expanding dipyridamole’s market application.

3. What factors could threaten aspirin’s continued dominance?
Emerging evidence favoring other antiplatelet or anticoagulant therapies with better safety profiles, such as direct oral anticoagulants (DOACs), could reduce aspirin’s usage, especially in primary prevention.

4. How significant is the generic market for aspirin?
Generics represent a dominant portion of aspirin sales due to patent expirations, ensuring affordability but limiting margins for manufacturers. This dynamic encourages volume-based sales over premium pricing strategies.

5. What role does market innovation play for dipyridamole?
Innovations in drug delivery and new clinical indications are vital for dipyridamole to compete effectively, especially as newer, more convenient therapies enter the market.

---

Sources

[1] WHO, "Aspirin in the Prevention of Cardiovascular Disease," 2021.
[2] MarketWatch, "Global Aspirin Market Size, Share & Trends Analysis," 2022.
[3] CDC, "Cardiovascular Disease Facts," 2022.
[4] FDA, "Risks of Aspirin in Primary Prevention," 2020.
[5] PharmaTimes, "Patent Expiry and Market Impact for Dipyridamole," 2019.