aspirin; omeprazole - Profile

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

International Patents:	9
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aspirin; omeprazole

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aspirin; omeprazole

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.

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
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No

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
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016

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)
Ukraine	115139	СПОСІБ ДОСТАВКИ ФАРМАЦЕВТИЧНОЇ КОМПОЗИЦІЇ, ЯКА МІСТИТЬ ОМЕПРАЗОЛ Й АЦЕТИЛСАЛІЦИЛОВУ КИСЛОТУ, ПАЦІЄНТУ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
World Intellectual Property Organization (WIPO)	2013101897
Brazil	112014016085	composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico
China	104519888	Improved compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Canada	2860231	COMPOSITIONS ET PROCEDES D'ADMINISTRATION D'OMEPRAZOLE PLUS ACIDE ACETYLSALICYLIQUE AMELIORES (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Eurasian Patent Organization	201491285	УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ

Aspirin; omeprazole Market Analysis and Financial Projection

Last updated: February 4, 2026

Investment Scenario and Fundamentals Analysis for Aspirin and Omeprazole

Aspirin: Market and Fundamentals

Market Overview
Aspirin, a non-steroidal anti-inflammatory drug (NSAID) with antiplatelet properties, remains a globally accessible over-the-counter medication. The drug’s sales are driven by its use in cardiovascular protection, pain relief, and anti-inflammatory indications.

Market Size and Trends

• Global aspirin market value stood at approximately $2.5 billion in 2021.[1]
• Projected compound annual growth rate (CAGR) of 2-3% through 2028, driven by aging populations and cardiovascular disease (CVD) prevalence.[2]
• Key markets: North America (43%), Europe (25%), Asia-Pacific (18%), remaining regions (14%).[3]

Regulatory Environment

• Aspirin's availability varies: over-the-counter (OTC) in North America and Europe; prescription in some Asian markets.
• Pending regulatory reviews are addressing long-term use safety concerns, particularly gastric bleeding.

R&D and Patent Landscape

• Patent expiry occurred in the early 2000s for many formulations.
• New formulations and combination drugs (e.g., aspirin with omeprazole) are under development to mitigate gastrointestinal side effects.[4]

Competitive Dynamics

• Major players include Bayer, Johnson & Johnson, and Teva.
• Generic penetration exceeds 80%.
• Pricing pressure remains high; volume sales determine profitability.

Investment Considerations

• Stable cash flows from mature markets.
• Growth opportunities involve expanding indications, particularly in secondary prevention of CVD.
• Regulatory risks and competitive generic pricing pressure challenge margins.

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Omeprazole: Market and Fundamentals

Market Overview
Omeprazole, a proton pump inhibitor (PPI), treats gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. It remains among the top-selling prescription medications worldwide.

Market Size and Trends

• Estimated global omeprazole market was valued at $6 billion in 2021.[5]
• CAGR forecast at 4-5% until 2028, supported by rising GERD prevalence and increased awareness.[6]
• Top markets: North America (35%), Europe (30%), Asia-Pacific (25%), others (10%).

Regulatory Environment

• Initial patents expired in the early 2000s, leading to widespread generics.
• New formulations and combination therapies seek to extend market life.
• Off-label use and OTC sales in some jurisdictions increase access but raise safety monitoring issues.

R&D and Patent Landscape

• Current R&D focuses on novel PPIs with improved safety profiles to address long-term therapy risks.
• Patent filings for formulations with delayed-release and combination therapies increased recently.

Competitive Dynamics

• Dominated by generics with a few branded players like AstraZeneca’s original formulations.
• Biosimilars and new PPI drugs pose competitive threats.
• Pricing remains aggressive, with discounts influencing market share.

Investment Considerations

• Mature market with steady revenue streams.
• Patent cliffs are mitigated by formulation improvements.
• Risks include market saturation, regulatory changes, and safety concerns.

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Comparison of Aspirin and Omeprazole: Investment Fundamentals

Aspect	Aspirin	Omeprazole
Market Size (2021)	~$2.5 billion	~$6 billion
Growth Rate (Forecast)	2-3% CAGR (2022-2028)	4-5% CAGR (2022-2028)
Patent Status	Expired; high generic penetration	Expired; intense competition from generics
Key Indications	CVD prevention, pain relief	GERD, ulcers, Zollinger-Ellison syndrome
Major Competitors	Bayer, Johnson & Johnson, Teva	AstraZeneca, generic companies
Regulatory Risks	Safety concerns (gastrointestinal bleeding)	Long-term safety, off-label uses, OTC regulation
Innovation Pipeline	Combination drugs (aspirin + omeprazole), reformulations	New formulations, biosimilars, combination therapies

Investment Perspective

• Aspirin has declining patent-derived margins but benefits from moderate growth in secondary prevention markets. Growth prospects hinge on developing new formulations and expanding indications. The mature patent landscape limits upside but offers stability.

• Omeprazole maintains a sizable and growing market with ongoing innovation, especially regarding improved formulations and combination therapies. Patent expirations have flattened near-term growth but opened avenues for reformulation-driven revenue.

Risks and Opportunities

• Risks: Regulatory safety concerns, pricing pressure due to generics, and competitive innovation.
• Opportunities: Growing global disease burden for both indications, pipeline development, potential biosimilars, and combination therapies.

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Key Takeaways

• Both drugs operate in mature markets with pricing pressures; future growth will depend on innovation and expanding indications.
• Aspirin's revenue stability is driven by its over-the-counter status and widespread use, despite limited new product development.
• Omeprazole's pipeline includes formulations aimed at addressing safety concerns and extending market life amid patent expirations.
• Investment decisions should consider regulatory developments, patent landscapes, and market trends, especially emerging markets with increasing disease prevalence.
• Both drugs face competitive and regulatory risks but benefit from established indications and global market presence.

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FAQs

1. What factors most influence aspirin's market growth?
Aging populations, cardiovascular disease prevalence, and development of combination formulations to address safety concerns.

2. How are patent expirations affecting omeprazole's profitability?
Patent expirations have led to extensive generic competition, reducing margins but stabilizing volume sales. Reformulations aim to extend market exclusivity.

3. What regulatory risks do these drugs face?
Potential safety issues such as gastrointestinal bleeding for aspirin and long-term safety concerns for PPIs like omeprazole could impact approvals and marketing.

4. Are biosimilars impacting omeprazole’s market?
While biosimilars are not directly applicable to omeprazole, generic PPIs and new formulations are eroding market share of branded versions.

5. What are the main drivers for future investment in these drugs?
Pipeline innovations, expanding indications, increasing global disease burden, and reformulation development to mitigate safety issues.

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Sources
[1] MarketWatch, "Global Aspirin Market Size," 2022.
[2] Research and Markets, "Pharmaceutical Markets Forecast," 2021.
[3] IQVIA, "Global Market Data," 2022.
[4] FDA filings, "Aspirin formulations," 2022.
[5] Grand View Research, "Proton Pump Inhibitors Market," 2021.
[6] MarketWatch, "Omeprazole Market Trends," 2022.