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Last Updated: December 11, 2025

ASPIRIN; OMEPRAZOLE - Generic Drug Details


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

Aspirin; omeprazole is the generic ingredient in one branded drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aspirin; omeprazole has nine patent family members in eight countries.

Summary for ASPIRIN; OMEPRAZOLE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ASPIRIN; OMEPRAZOLE
Generic Entry Date for ASPIRIN; OMEPRAZOLE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, DELAYED RELEASE;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; OMEPRAZOLE

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

SponsorPhase
University of Michigan Rogel Cancer CenterEARLY_PHASE1
National Cancer Institute (NCI)EARLY_PHASE1
Federal University of São PauloPhase 4

See all ASPIRIN; OMEPRAZOLE clinical trials

Paragraph IV (Patent) Challenges for ASPIRIN; OMEPRAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
YOSPRALA Delayed-release Tablets aspirin; omeprazole 81 mg/40 mg and 325 mg/40 mg 205103 1 2016-10-17
YOSPRALA Delayed-release Tablets aspirin; omeprazole 81 mg/40 mg and 325 mg/40 mg 205103 1 2016-10-14

US Patents and Regulatory Information for ASPIRIN; OMEPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No 9,539,214 ⤷  Get Started Free ⤷  Get Started Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No 9,539,214 ⤷  Get Started Free ⤷  Get Started Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No 9,987,231 ⤷  Get Started Free ⤷  Get Started Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No 9,987,231 ⤷  Get Started Free ⤷  Get Started Free
>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; OMEPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 6,926,907 ⤷  Get Started Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 6,926,907 ⤷  Get Started Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 8,206,741 ⤷  Get Started Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 9,364,439 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ASPIRIN; OMEPRAZOLE

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 028049 УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID) ⤷  Get Started Free
Brazil 112014016085 composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico ⤷  Get Started Free
Ukraine 115139 СПОСІБ ДОСТАВКИ ФАРМАЦЕВТИЧНОЇ КОМПОЗИЦІЇ, ЯКА МІСТИТЬ ОМЕПРАЗОЛ Й АЦЕТИЛСАЛІЦИЛОВУ КИСЛОТУ, ПАЦІЄНТУ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID) ⤷  Get Started Free
Eurasian Patent Organization 201491285 УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for Aspirin and Omeprazole

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is profoundly shaped by the continuous evolution of drug demand, technological innovations, regulatory frameworks, and competitive dynamics. Aspirin and Omeprazole epitomize two distinct yet highly influential classes within this sector—analgesic/antiplatelet agents and proton pump inhibitors (PPIs), respectively. Their market trajectories are driven by unique clinical, consumer, and economic factors, reflecting broader shifts in healthcare priorities and pharmaceutical innovation.

This analysis delineates the current market landscape and forecasts the future financial trajectory of Aspirin and Omeprazole, integrating market drivers, challenges, regulatory influences, and emerging trends.


Market Overview: Aspirin

Historical Context and Usage

Aspirin (acetylsalicylic acid), introduced in the late 19th century, remains a cornerstone in cardiovascular disease prevention and pain management. The longstanding clinical endorsement of low-dose Aspirin for secondary prevention of myocardial infarction (MI) and stroke has established its position globally. It is classified as a generic drug, with widespread accessibility and relatively low manufacturing costs.

Market Drivers

  • Cardiovascular Disease (CVD) Burden: The rising prevalence of CVD globally fuels sustained demand. The World Health Organization (WHO) reports CVD as the leading cause of death, underscoring Aspirin's role in prophylaxis[1].
  • Guideline Recommendations: Evidence-based guidelines endorse low-dose Aspirin for secondary prevention, reinforcing prescribing trends.
  • Over-the-counter (OTC) Accessibility: Over-the-counter availability in many markets amplifies consumer access, although it poses challenges related to misuse.
  • Generic Competition: The dominance of generic formulations constrains pricing power but maintains broad market penetration.

Market Challenges

  • Bleeding Risks: Growing awareness of Aspirin's adverse effects, particularly bleeding, prompts reevaluation of its prophylactic use in low-risk populations.
  • Emerging Alternatives: New antiplatelet agents, such as P2Y12 inhibitors, offer alternative options for specific indications.
  • Regulatory Shifts: Recent updates to clinical guidelines and regulatory warnings influence prescribing behaviors.

Financial Trajectory

The global Aspirin market was valued at approximately USD 2.5 billion in 2022, with projections indicating moderate growth at a compound annual growth rate (CAGR) of around 2–3% through 2030[2]. The mature status of the market, driven by high generic penetration and established clinical use, suggests limited upside but stable revenues. Emerging evidence questioning routine low-dose Aspirin for primary prevention could temper growth further, especially in developed markets.


Market Overview: Omeprazole

Historical Context and Usage

Omeprazole—marketed as Prilosec and in various generic forms—is a pioneer in the PPI class, introduced in the early 1990s. It revolutionized acid-related disorder management, including gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger-Ellison syndrome. Its potent, targeted acid suppression quickly made it a first-line therapy.

Market Drivers

  • Rising Gastrointestinal Disorders: Increasing prevalence of GERD, obesity, and lifestyle-related conditions sustains high demand.
  • Expanding Indications: Emerging uses, including eradication of Helicobacter pylori and prevention of NSAID-induced ulcers, broaden the market scope.
  • Brand and Generic Competition: Multiple generics significantly reduce costs, enhancing accessibility.
  • Over-the-counter Availability: Availability without prescription in many jurisdictions broadens consumer access.

Market Challenges

  • Safety Concerns: Long-term PPI use associates with risks such as renal impairment, nutrient malabsorption, and potential cardiovascular effects, impacting prescribing patterns.
  • Emerging Therapies: Novel agents like potassium-competitive acid blockers (P-CABs) threaten market share.
  • Regulatory Scrutiny: Warnings regarding overuse and potential adverse effects influence physician and patient behaviors.

Financial Trajectory

The global Omeprazole market valued approximately USD 8–9 billion in 2022, with expected CAGR of around 4–6% over the next decade[3]. The high demand, widespread prescription, and OTC sales underpin robust growth. The proliferation of long-term use and expanding indications will continue to sustain revenue streams, despite concerns over safety and the introduction of newer therapies.


Market Dynamics Analysis

Key Growth Factors

  • Aspirin: Its role in secondary prevention maintains stable demand. Innovation in formulations (e.g., enteric-coated, combination with other agents) offers incremental revenue. Public health initiatives promoting CVD risk reduction support ongoing usage.
  • Omeprazole: The prevalence of acid-related disorders and broadening indications will sustain demand. Advances in drug delivery systems and combination therapies strengthen the market.

Market Risks

  • Patent Expirations: Aspirin's status as a generic limits potential revenue growth. Omeprazole's patent expiry facilitated price competition but stabilized with the rise of generics.
  • Regulatory and Safety Concerns: Heightened awareness of adverse effects induces cautious prescribing. This impacts the growth trajectory, particularly for Aspirin's primary prevention use.
  • Competitive Landscape: For Omeprazole, newer PPIs and P-CABs challenge market share, while for Aspirin, alternative antithrombotic agents contest its prophylactic role.

Emerging Trends Impacting Future Trajectory

  • Personalized Medicine: Advances may refine patient selection, optimizing efficacy and safety, affecting demand patterns.
  • Digital Health & Education: Increased awareness regarding appropriate usage influences consumption trends.
  • Market Consolidation: Mergers and acquisitions among generic manufacturers can influence pricing and supply dynamics.
  • Regulatory Policies: Stricter guidelines for long-term use and OTC sales could reshape market shares.

Financial Forecasts and Strategic Implications

Aspirin

  • Revenue Outlook: Expected modest growth (~2–3% CAGR) through 2030, constrained by market maturity, safety considerations, and evolving guidelines.
  • Market Opportunities: Potential lies in combination therapies, preventive outreach, and mining niche markets (e.g., women’s health, elderly populations).
  • Strategic Focus: Ensuring product differentiation through formulations and clinical positioning while monitoring safety profiles remains critical.

Omeprazole

  • Revenue Outlook: Projected steady growth (~4–6% CAGR) over the next decade driven by increasing gastrointestinal disorder prevalence and expanding indications.
  • Market Opportunities: Development of next-generation PPIs and P-CABs, along with formulations enhancing patient compliance.
  • Strategic Focus: Companies should invest in R&D to stay ahead of rivals, coupled with pharmacovigilance efforts to maintain safety profiles.

Regulatory and Market Access Considerations

  • Stringent regulation of OTC sales and long-term indications will influence market access strategies.
  • Health system reimbursement policies and governmental initiatives aimed at reducing healthcare costs impact pricing and distribution strategies.
  • Data demonstrating safety and efficacy underlying guideline updates will determine future prescribing trends.

Conclusion

The market dynamics and financial trajectories of Aspirin and Omeprazole reflect their entrenched roles within modern medicine, yet are subject to shifts driven by safety profiles, innovation, and regulatory landscapes. Aspirin’s mature, stable market faces incremental growth constraints, whereas Omeprazole exhibits more robust growth potential owing to ongoing demand and expanding indications.

Strategic positioning for stakeholders must encompass vigilant monitoring of safety data, embracing innovation, and aligning with evolving clinical guidelines to maximize opportunities within this competitive landscape.


Key Takeaways

  • Aspirin’s prolonged dominance in cardiovascular prevention yields stable but modest growth, with market challenges stemming from safety concerns and evolving guidelines.
  • Omeprazole continues to experience substantial demand, with growth propelled by a high prevalence of acid-related disorders and broadening therapeutic uses.
  • Patent expiries and generic proliferation challenge pricing power, necessitating innovation and formulation differentiation.
  • Safety concerns and regulatory scrutiny will impact prescribing patterns, particularly for long-term use.
  • Integration of personalized medicine, digital health, and emerging therapies will shape future market landscapes.

FAQs

  1. What factors influence the declining use of Aspirin for primary prevention?
    Increased awareness of bleeding risks, updated clinical guidelines emphasizing risk stratification, and emerging evidence questioning benefits in low-risk populations contribute to decreased primary prevention use.

  2. How are generic versions impacting Omeprazole’s market?
    The availability of numerous generics has significantly lowered prices, expanded access, and stabilized revenues, although it compresses profit margins for manufacturers.

  3. What emerging alternatives threaten Aspirin’s market share?
    P2Y12 inhibitors, such as clopidogrel and ticagrelor, offer alternative antithrombotic options, especially for acute coronary syndrome and stenting procedures.

  4. Are new therapies expected to replace Omeprazole in acid suppression?
    Yes, P-CABs like Vonoprazan demonstrate promising efficacy and safety profiles, potentially challenging Omeprazole’s dominance once approved broadly.

  5. How can pharmaceutical companies adapt to regulatory changes affecting these drugs?
    Companies should invest in robust pharmacovigilance, conduct post-market studies, and engage with regulatory agencies to ensure compliance and demonstrate safety, thereby preserving market access and reputation.


References:

[1] World Health Organization. Cardiovascular Diseases (CVDs). 2022.

[2] MarketWatch. Aspirin Market Size & Share Report, 2022.

[3] GlobalData. Proton Pump Inhibitors Market Forecast, 2022–2032.

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