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, Nostrum Labs Inc, 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, Bausch, Galt Pharms, Alra, Xanodyne Pharm, Ivax Sub Teva Pharms, Teva, Chartwell Rx, 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
Jawaharlal Institute of Postgraduate Medical Education & Research	Phase 3

See all ASPIRIN clinical trials

Generic filers with tentative approvals for ASPIRIN

Applicant	Application No.	Strength	Dosage Form
		81MG;40MG	TABLET;ORAL
		325MG;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
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes	10,646,431		Y
Dr Reddys Labs Sa	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride	TABLET;ORAL	091670-001	Mar 16, 2011		DISCN	No	No
Ivax Pharms	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	085441-002	Oct 31, 1984		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	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
Mexico	340951	PORTADORES DEPENDIENTES DEL PH PARA LA LIBERACION DIRIGIDA DE PRODUCTOS FARMACEUTICOS A LO LARGO DEL TRACTO GASTROINTESTINAL, COMPOSICIONES DE LOS MISMOS, Y FABRICACIÓN Y USO DE LAS MISMAS. (pH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME.)
Japan	6368645
Japan	2020090499	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 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

ASPIRIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Aspirin

Introduction to Aspirin Market

Aspirin, one of the most widely used medications globally, is experiencing significant growth driven by various market dynamics. Here, we delve into the key factors influencing the aspirin market and its financial trajectory.

Market Size and Growth Projections

The global aspirin market is anticipated to grow substantially over the next decade. Here are some key projections:

• Current Market Size: The aspirin market was valued at approximately USD 2.47 billion in 2023 and is expected to reach USD 2.59 billion in 2024, growing at a CAGR of 4.9%[4].
• Future Projections: By 2034, the market is expected to expand to USD 4.236.9 million, driven by a consistent CAGR of 3.8% from 2024 to 2034[2][5].

Drivers of Market Growth

Several factors are driving the growth of the aspirin market:

Increasing Prevalence of Cardiovascular Diseases

Cardiovascular diseases, such as heart attacks and strokes, are major drivers of the aspirin market. Aspirin is widely used as a therapeutic and preventive measure for these conditions. The increasing incidence of cardiac diseases globally is a significant factor in market growth[1][5].

Technological Advancements in Drug Delivery Systems

Advances in drug delivery systems have led to the development of aspirin formulations with controlled release times, enabling once-daily dosing and potentially reducing gastrointestinal side effects. These innovations improve patient adherence and support market expansion[1][3].

Rising Geriatric Population

The global aging population is contributing to an increase in age-related illnesses such as cardiovascular disease and arthritis, for which aspirin is frequently prescribed. This demographic shift is a key driver of future market growth[1].

Growing Incidence of Chronic Conditions

Conditions like arthritis, pain, inflammation, renal disorders, and brain strokes are on the rise, driving the demand for aspirin. Public and private initiatives to raise awareness about myocardial infarction are also boosting market scope[2][5].

Market Segmentation

Route of Administration

The oral route of administration dominates the aspirin market due to its widespread use in treating cardiac disorders and other conditions[1].

Dosage Forms

Tablets and capsules are the primary dosage forms, with combination aspirin drugs leading the market. For instance, combination aspirin drugs accounted for about 68% of the global market share in 2023[2].

Geographical Distribution

• United States: Expected to hold a significant market share, driven by the increasing need for aspirin to manage chronic pain. The U.S. market is projected to grow at a CAGR of 3.9% from 2024 to 2034[2].
• India: The aspirin market in India is set to exhibit a CAGR of 3.4% by 2034, driven by substantial financing and healthcare programs like Pradhan Mantri Jan Arogya Yojana and Ayushman Bharat[2].

Pharmaceutical Industry Innovations

The pharmaceutical industry's efforts in discovering novel treatments and developing effective drug formulations are crucial for market growth. For example, the launch of rosuvastatin, aspirin, and clopidogrel FDC (Fixed Dose Combination) by Dr Reddy's Laboratories in 2019 is a significant development[2].

Regulatory and Awareness Factors

Public and private organizations' initiatives to spread awareness about myocardial infarction and other cardiovascular diseases are expected to elevate market scope. Regulatory frameworks and pricing analyses also play a critical role in shaping the market[1][5].

Challenges and Opportunities

Challenges

Despite the growth, the aspirin market faces challenges such as side effects, particularly gastrointestinal issues, and the availability of alternative medications.

Opportunities

• Combination Therapies: The dominance of combination aspirin drugs presents opportunities for pharmaceutical manufacturers to develop more effective and safer formulations[2].
• Customized Dosage Forms: The trend towards personalized medicine and customized dosage forms offers potential for innovation and market expansion[4].
• Telemedicine and Self-Care: The growing popularity of telemedicine and self-care practices is expected to increase the demand for aspirin and other over-the-counter medications[4].

Key Statistics

• Global Market Value: Expected to rise from USD 2.938.2 million in 2024 to USD 4.236.9 million by 2034[5].
• CAGR: Projected CAGR of 3.8% from 2024 to 2034[2][5].
• Cardiovascular Disease Impact: According to the WHO, 32% of all deaths worldwide were due to CVDs in 2019, which is around 17.9 million people[5].

"Several patients widely accept aspirin due to their reputation as an effective medication for chronic diseases. Consequently, sales of aspirin drugs are predicted to observe a substantial rise over the expected period," - Sabyasachi Ghosh, Associate Vice President at Future Market Insights, Inc.[5]

Regional Insights

United States

The U.S. market is driven by the increasing need for aspirin to manage chronic pain, with a prevalence of chronic pain and high-impact chronic pain among adults being significant factors. The market in the U.S. is expected to grow at a CAGR of 3.9% from 2024 to 2034[2].

India

India's aspirin market is boosted by substantial financing and healthcare programs, which offer accessible healthcare facilities and reimbursement options. The market in India is set to exhibit a CAGR of 3.4% by 2034[2].

Conclusion

The aspirin market is poised for significant growth driven by increasing prevalence of cardiovascular diseases, technological advancements, and a rising geriatric population. The market's financial trajectory is expected to be robust, with a projected CAGR of 3.8% from 2024 to 2034. Pharmaceutical innovations, combination therapies, and growing awareness about chronic diseases are key factors shaping the market's future.

Key Takeaways

• Market Growth: The aspirin market is expected to grow from USD 2.938.2 million in 2024 to USD 4.236.9 million by 2034.
• CAGR: A projected CAGR of 3.8% from 2024 to 2034.
• Drivers: Increasing prevalence of cardiovascular diseases, technological advancements, and a rising geriatric population.
• Market Segmentation: Oral route of administration dominates, with combination aspirin drugs leading the market.
• Regional Insights: The U.S. and India are key markets, driven by chronic pain management and healthcare programs.

FAQs

Q: What is the current market size of the aspirin market? A: The aspirin market was valued at approximately USD 2.47 billion in 2023[4].

Q: What is the projected CAGR of the aspirin market from 2024 to 2034? A: The aspirin market is expected to grow at a CAGR of 3.8% from 2024 to 2034[2][5].

Q: Which segment dominates the aspirin market in terms of route of administration? A: The oral route of administration dominates the aspirin market[1].

Q: What are the key drivers of the aspirin market? A: The key drivers include increasing prevalence of cardiovascular diseases, technological advancements in drug delivery systems, and a rising geriatric population[1][3].

Q: Which region is expected to hold a significant market share in the aspirin market? A: The United States is expected to hold a significant market share, driven by the increasing need for aspirin to manage chronic pain[2].

Sources

1. Data Bridge Market Research: Global Aspirin Market – Industry Trends and Forecast to 2030.
2. Future Market Insights: Aspirin Drug Market Size, Share & Forecast to 2034.
3. GlobeNewswire: Technological Advancements and Increasing Prevalence of Arthritis Drive Innovation in the Global Aspirin Market.
4. The Business Research Company: Global Aspirin Market Report 2024.
5. PR Newswire: Aspirin Drug Market to Soar to US$4.2 Billion by 2034, Driven by Combination Aspirins' Dominance – Future Market Insights, Inc.