ASPIRIN; DIPYRIDAMOLE - Generic Drug Details

What are the generic 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, Endo Operations, Glenmark Speclt, Micro Labs, Sandoz, Sun Pharm, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for ASPIRIN; DIPYRIDAMOLE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	25
Patent Applications:	92
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
Zydus Pharms	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	206753-001	Aug 29, 2017	AB	RX	No	No
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
Chartwell Molecular	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	204552-001	Mar 20, 2019		DISCN	No	No
Endo Operations	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	207944-001	Jan 18, 2017	AB	RX	No	No
Ani Pharms	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	206964-001	Jan 18, 2017		DISCN	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	6,015,577

ASPIRIN; DIPYRIDAMOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Aspirin and Dipyridamole

Market Overview

The aspirin market, which often includes combinations with other drugs like dipyridamole, is a significant segment within the pharmaceutical industry. Here are the key dynamics and financial projections for this market.

Market Size and Growth

The global aspirin market is projected to grow steadily over the coming years. As of 2020, the market size was estimated at $2.167 billion, and it is expected to reach $2.558 billion by 2027, growing at a CAGR of 2.40%[1][4].

However, more recent projections suggest a higher growth rate, with the market expected to reach $3.42 billion by 2030, growing at a CAGR of 4.62% from 2023 to 2030[3].

Market Drivers

Several factors are driving the growth of the aspirin market:

Increasing Prevalence of Chronic Diseases

The rising global geriatric population and the increasing prevalence of chronic diseases such as cardiovascular diseases are significant drivers. Aspirin's preventive cardiovascular benefits are well-documented, making it a staple in many older adults' medication regimens[3].

Expanding Applications

Aspirin's potential applications beyond cardiovascular health, including its anticancer properties and possible use in managing dementia, are opening new therapeutic avenues. This expansion is expected to attract more investment in R&D and strategic partnerships[3].

Growing Retail and E-commerce

The augmenting retail industry and booming e-commerce sales are also propelling market growth. During the COVID-19 pandemic, online sales of essential items, including aspirin, saw a significant increase as consumers preferred online retailing over physical stores[4].

Market Restraints

Despite the growth drivers, there are several restraints to consider:

Gastrointestinal Side Effects and Bleeding Risk

Aspirin's well-known gastrointestinal side effects and increased risk of bleeding are significant limitations. These side effects can lead to a broader acceptance challenge for aspirin, especially with the emergence of alternative medications with fewer side effects[3].

Regulatory Constraints

Stringent regulatory requirements for the approval of new formulations and applications of aspirin also pose a challenge. Companies must navigate these regulations carefully to bring new products to market[3].

Availability of Alternative Medications

The availability of alternative medications with improved efficacy and fewer side effects is another restraint. For instance, clopidogrel, while not always cost-effective, offers an alternative antiplatelet therapy that may be preferred in certain cases[2][5].

Market Opportunities

There are several opportunities for growth and innovation in the aspirin market:

Investment in R&D

Investing in R&D for enhanced formulations of aspirin can help mitigate side effects and improve efficacy. This could include developing new delivery systems or combining aspirin with other drugs to enhance its therapeutic benefits[3].

Strategic Partnerships

Forming strategic partnerships with academic and medical institutions can accelerate research into aspirin's anticancer and dementia management potential. Such collaborations can lead to new therapeutic applications and market expansion[3].

Online Platforms and Telemedicine

The burgeoning growth in online platforms and telemedicine offers new distribution channels for aspirin. This shift can make aspirin more accessible, especially in regions with limited physical healthcare infrastructure[3].

Financial Trajectory

Current Market Value

As of 2023, the aspirin market was valued at $2.49 billion, increasing to $2.58 billion in 2024. It is projected to reach $3.42 billion by 2030[3].

Cost-Effectiveness

Health economic analyses have shown that certain combinations of aspirin, such as aspirin plus extended-release dipyridamole (ASA/ER-DP), can be cost-effective compared to monotherapy with aspirin or other antiplatelet agents like clopidogrel. For example, ASA/ER-DP was found to be cost-effective for the secondary prevention of stroke with a cost-effectiveness ratio of $28,472, whereas clopidogrel was not cost-effective in this context[2].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the aspirin market. While import limitations on active pharmaceutical ingredients affected supply chains, the increased demand for aspirin due to its use in treating COVID-19 symptoms like headaches and fever helped to offset some of these disruptions[4].

Distribution Channels

The market is segmented into online and offline distribution channels. Offline channels currently hold a significant market share, but online channels are growing rapidly due to increasing internet penetration and consumer preference for online retailing[4].

Regional Market Share

China, from the APAC region, is estimated to hold a significant market share in the global API industry, which includes aspirin. The growing API industry in this region is a key driver of the aspirin market's expansion[1][4].

Key Takeaways

• The aspirin market is expected to grow at a CAGR of 4.62% from 2023 to 2030, reaching $3.42 billion by 2030.
• The market is driven by the increasing prevalence of chronic diseases, expanding applications of aspirin, and growing retail and e-commerce sales.
• Despite growth drivers, the market faces restraints such as gastrointestinal side effects, regulatory constraints, and the availability of alternative medications.
• Investment in R&D, strategic partnerships, and the growth of online platforms offer significant opportunities for market expansion.
• The cost-effectiveness of aspirin combinations, such as ASA/ER-DP, is a key factor in their adoption for secondary stroke prevention.

FAQs

Q: What is the projected market size of the aspirin market by 2030?

A: The aspirin market is expected to reach $3.42 billion by 2030, growing at a CAGR of 4.62% from 2023 to 2030[3].

Q: What are the main drivers of the aspirin market growth?

A: The main drivers include the increasing prevalence of chronic diseases, expanding applications of aspirin, and the growth of retail and e-commerce sales[3].

Q: What are the significant restraints to the aspirin market?

A: The restraints include gastrointestinal side effects, regulatory constraints, and the availability of alternative medications with improved efficacy and fewer side effects[3].

Q: How has the COVID-19 pandemic impacted the aspirin market?

A: The pandemic had a mixed impact, with import limitations affecting supply chains but increased demand for aspirin due to its use in treating COVID-19 symptoms helping to offset these disruptions[4].

Q: What are the emerging opportunities in the aspirin market?

A: Emerging opportunities include investment in R&D for enhanced formulations, strategic partnerships for new therapeutic applications, and the growth of online platforms and telemedicine[3].

Sources

1. Global Aspirin Market Report 2022: Growing Active Pharmaceutical Ingredient Industry Bolsters Sector Expansion - GlobeNewswire[1]
2. Aspirin plus extended-release dipyridamole or clopidogrel for prevention of recurrent ischemic stroke - PubMed[2]
3. The $3.42 Billion Aspirin Industry 2025-2030: Emerging Opportunities in Aspirin's Anticancer and Dementia Research Drive Potential for R&D and Strategic Partnerships - GlobeNewswire[3]
4. Global Aspirin Market Size & Share: Industry Report, 2022-2027 - Knowledge Sourcing[4]
5. Aspirin and extended-release dipyridamole versus clopidogrel for prevention of recurrent ischemic stroke - PubMed[5]