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Last Updated: December 24, 2024

Aspirin - Generic Drug Details


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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.

Drug Prices for aspirin

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Drug Sales Revenue Trends for aspirin

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Recent Clinical Trials for aspirin

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

SponsorPhase
Zunyi Medical CollegePhase 4
Assistance Publique Hopitaux De MarseilleN/A
North Eastern Indira Gandhi Regional Institute of Health ans Medical SciencesPhase 3

See all aspirin clinical trials

Generic filers with tentative approvals for ASPIRIN
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe325MG;40MGTABLET;ORAL
⤷  Subscribe⤷  Subscribe81MG;40MGTABLET;ORAL

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

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
Sun Pharm Industries OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 040260-001 Jul 17, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm ASPIRIN AND DIPYRIDAMOLE aspirin; dipyridamole CAPSULE, EXTENDED RELEASE;ORAL 208572-001 Aug 21, 2018 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride TABLET;ORAL 040910-001 Jul 16, 2020 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Oxford Pharms CARISOPRODOL AND ASPIRIN aspirin; carisoprodol TABLET;ORAL 040252-001 Dec 10, 1997 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Molecular ASPIRIN AND DIPYRIDAMOLE aspirin; dipyridamole CAPSULE, EXTENDED RELEASE;ORAL 204552-001 Mar 20, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alra COMPOUND 65 aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 084553-002 Aug 17, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aaipharma Llc DARVON-N W/ ASA aspirin; propoxyphene napsylate CAPSULE;ORAL 016829-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe ⤷  Subscribe
Plx Pharma VAZALORE aspirin CAPSULE;ORAL 203697-001 Jan 14, 2013 ⤷  Subscribe ⤷  Subscribe
Plx Pharma VAZALORE aspirin CAPSULE;ORAL 203697-001 Jan 14, 2013 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for aspirin

Country Patent Number Title Estimated Expiration
Mexico 356017 PORTADORES DEPENDIENTES DE PH PARA LA LIBERACION DIRIGIDA DE PRODUCTOS FARMACEUTICOS A LO LARGO DEL TRACTO GASTROINTESTINAL, COMPOSICIONES DE LOS MISMOS, Y FABRICACION Y USO DE LAS MISMAS. (pH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME.) ⤷  Subscribe
Japan 6368645 ⤷  Subscribe
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) ⤷  Subscribe
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) ⤷  Subscribe
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.) ⤷  Subscribe
South Korea 20140105436 PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2013049749 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aspirin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 122012000017 Germany ⤷  Subscribe 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 ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.