ASPIRIN; OMEPRAZOLE - Generic Drug Details

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
Clinical Trials:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASPIRIN; OMEPRAZOLE
DailyMed Link:	ASPIRIN; OMEPRAZOLE at DailyMed

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.

Recent Clinical Trials for ASPIRIN; OMEPRAZOLE

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

Sponsor	Phase
National Cancer Institute (NCI)	EARLY_PHASE1
University of Michigan Rogel Cancer Center	EARLY_PHASE1
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all ASPIRIN; OMEPRAZOLE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ASPIRIN; OMEPRAZOLE

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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	205103-002	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	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	205103-001	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	205103-002	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)
Brazil	112014016085	composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico
Brazil	112014016085	composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico

Market Dynamics and Financial Trajectory for Aspirin and Omeprazole

Last updated: February 13, 2026

What are the current market sizes and growth projections for aspirin and omeprazole?

Aspirin:

• Global market size estimated at USD 7.8 billion in 2022.
• Compound annual growth rate (CAGR) projected at 3.2% from 2023 to 2030.
• Predominantly used for cardiovascular protection, pain relief, and antipyretic effects.
• Decline in low-dose usage driven by increased availability of alternative antiplatelet agents.

Omeprazole:

• Global proton pump inhibitor (PPI) market valued at USD 14.3 billion in 2022.
• CAGR forecasted at 4.7% through 2030.
• Largest shareholder among PPIs attributable to its early market entry and widespread generic availability.
• Used for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

How do patent statuses influence market dynamics?

Aspirin:

• Generic availability since 1919; no current patents.
• Market dominated by OTC formulations; few innovations post-patent expiry.
• Brand-specific aspirin products remain niche, primarily for marketing reasons.

Omeprazole:

• Patents expired in major markets between 2009 and 2014.
• Generics now dominate the market, reducing prices and margins.
• Several formulations (e.g., delayed-release, fixed-dose combinations) remain under patent in specific regions, creating current or potential exclusivity.

What are the key competitive forces shaping the market?

• Aspirin:

  • Limited competition due to patent expiry.
  • Market share held by major players like Bayer, Johnson & Johnson, and generic manufacturers.
  • Shift towards combination therapies with other antiplatelets for specific indications.

• Omeprazole:

  • Fragmented landscape with numerous generic companies.
  • Presence of subsequent-generation PPIs like esomeprazole and pantoprazole, competing on efficacy and safety profiles.
  • Increasing interest in novel drug delivery systems to improve patient compliance.

What are the technological and regulatory influences?

Aspirin:

• Safety concerns around gastrointestinal bleeding and Reye’s syndrome limit new formulations.
• Regulatory approval processes focus on reformulations for reduced side effects rather than new molecular entities.

Omeprazole:

• Patent expiries led to proliferation of generics.
• Regulatory scrutiny emphasizes bioequivalence and manufacturing standards.
• Development of combination drugs and novel delivery methods face variable regulatory pathways.

How do pricing and reimbursement policies impact market outlook?

Aspirin:

• OTC pricing remains low, with minimal reimbursement barriers.
• Cost-effectiveness supports extensive use for primary prevention in risk groups.

Omeprazole:

• Reimbursement models influence brand versus generic market shares.
• Price erosion from generics pressures profit margins, especially in developed markets.
• New formulations or patented combinations can command premium pricing.

What are the primary risks and opportunities?

• Aspirin:

  • Risks: Adverse effects discouraging use, competition from other antithrombotic drugs.
  • Opportunities: New indications, developing formulations with improved safety profiles.

• Omeprazole:

  • Risks: Regulatory challenges for new formulations, adverse event concerns like Clostridioides difficile infections.
  • Opportunities: Growing demand for GERD treatments, innovative delivery systems, and combination therapies.

How do market entry barriers affect future growth?

• For aspirin, low barriers due to generic prevalence; innovation is limited.
• For omeprazole, patent expiries and widespread generics reduce barriers but create price competition.
• Enforcing formulation patents or new drug delivery patents remain a pathway to maintain exclusivity.

What are the financial prospects over the coming five years?

Aspect	Aspirin	Omeprazole
Revenue Trends	Flat or slight decline; stabilization expected	Moderate growth driven by new formulations and region expansion
Profit Margins	Marginal; highly commoditized market	Declining due to price erosion in generics
R&D Investment	Minimal; focus on reformulation	Moderate; innovation in delivery technology
Market Penetration Opportunities	Limited; focus on niche and combination therapies	High in emerging markets and for new indications

Conclusions

Aspirin maintains its position as a low-cost OTC drug with gradual revenue stagnation due to widespread generic availability and safety concerns limiting new innovations. Omeprazole, on the other hand, faces inevitable price pressures post-patent expiry but retains opportunities through new formulations, combinations, and expanded regional markets. Both markets exhibit high competition, with generics dominating their respective landscapes.

Key Takeaways

• Aspirin’s market is mature, with limited growth prospects but a stable revenue base driven by OTC sales.
• Omeprazole’s market benefits from expanding indications and formulations despite price erosion from generics.
• Patent management and formulation innovations remain critical for maintaining profitability.
• Regulatory environments continue to influence market strategies and uptake.
• Entry barriers favor generic companies; innovation is necessary for premium pricing.

FAQs

1. What factors lead to aspirin’s pricing stability despite patent expiration?
Aspirin’s OTC status and widespread generic competition keep prices low and stable. Few proprietary formulations or delivery innovations have emerged post-patent expiry.

2. How significant are brand-name formulations of omeprazole in today’s market?
Brand-name versions of omeprazole are now a minor segment in markets dominated by generics due to patent expiries and cost pressures.

3. Are there upcoming innovations that could disrupt these markets?
For aspirin, reformulations with reduced side effects are unlikely to generate significant revenue. Omeprazole could see innovation through advanced delivery systems or novel combinations, but regulatory hurdles persist.

4. How do reimbursement policies affect market growth?
Reimbursement favors generics in many regions, pressuring margins but promoting broader access. The price sensitivity limits innovation-driven premium products.

5. What are the regions with the highest growth potential?
Emerging markets exhibit growth for both drugs, driven by increasing healthcare access, aging populations, and expanding disease prevalence.

---

Citations

[1] Market Research Future, "Aspirin Market Research Report," 2022.
[2] Grand View Research, "Proton Pump Inhibitors Market Size, Share & Trends," 2022.