YOSPRALA Drug Patent Profile

When do Yosprala patents expire, and what generic alternatives are available?

Yosprala is a drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has nine patent family members in eight countries.

The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; omeprazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Yosprala

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 2, 2033. This may change due to patent challenges or generic licensing.

There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for YOSPRALA

International Patents:	9
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YOSPRALA

Paragraph IV (Patent) Challenges for YOSPRALA

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 YOSPRALA

YOSPRALA is protected by two US patents.

This potential generic entry date is based on patent 9,987,231.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No	9,987,231
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		DISCN	Yes	No	9,987,231
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No	9,539,214

International Patents for YOSPRALA

When does loss-of-exclusivity occur for YOSPRALA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Mexico

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering YOSPRALA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2012502015
Eurasian Patent Organization	028049	УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Eurasian Patent Organization	028049	УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Mexico	2011002515	METODO DE ADMINISTRACION DE UNA COMPOSICION FARMACEUTICA A UN PACIENTE QUE LO NECESITA. (METHOD FOR DELIVERING A PHARMACEUTICAL COMPOSITION TO PATIENT IN NEED THEREOF.)
Eurasian Patent Organization	201100313	СПОСОБ ДОСТАВКИ ФАРМАЦЕВТИЧЕСКОЙ КОМПОЗИЦИИ ПАЦИЕНТУ, НУЖДАЮЩЕМУСЯ В ЭТОМ
Portugal	1411900
Mexico	2014007935	COMPOSICIONES Y METODOS MEJORADOS PARA EL SUMINISTRO DE OMEPRAZOL Y DE ACIDO ACETILSALICILICO. (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID.)

Supplementary Protection Certificates for YOSPRALA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	1190013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900	122012000052	Germany		PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900	132012902015795	Italy		PRODUCT NAME: NAPROSSENE E ESOMEPRAZOLO SALE DI MAGNESIO TRIIDRATO(VIMOVO); AUTHORISATION NUMBER(S) AND DATE(S): PL 17901/0263-0001, 20101105;DA 40611016/M A 40611129/M, 20110808
1411900	18/2011	Austria		PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
1411900	91858	Luxembourg		91858, EXPIRES: 20251105
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17901/0263-001 20101105

YOSPRALA (Aspirin and Esomeprazole Magnesium): Market and Investment Analysis

Last updated: February 3, 2026

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Executive Summary

YOSPRALA (combination of aspirin and esomeprazole magnesium) is an FDA-approved medication primarily indicated for secondary prevention of cardiovascular events in patients at risk of gastrointestinal bleeding. The drug targets a significant segment within cardiology and gastroenterology, addressing unmet needs in patients requiring antiplatelet therapy with concurrent gastrointestinal risk factors.

This analysis outlines the current market landscape, competitive dynamics, growth projections, and investment considerations for YOSPRALA, providing a comprehensive view for stakeholders.

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1. Product Overview and Indication Landscape

Attribute	Details
Generic name	Aspirin + Esomeprazole Magnesium
Brand name	YOSPRALA
Approval Date	May 2016 (FDA)
Indication	Secondary prevention of cardiovascular events in patients at risk of gastrointestinal bleeding
Dosage Forms	Tablets (81 mg aspirin + 20 mg esomeprazole) and (325 mg aspirin + 40 mg esomeprazole)

Pharmacodynamics: Aspirin inhibits platelet aggregation; esomeprazole reduces gastric acid, mitigating gastrointestinal bleeding risks associated with antiplatelet therapy.

2. Market Dynamics

Global and U.S. Market Size

Metric	Value (USD billion)	Year	Source
Total aspirin market	~$1.2	2022	[1]
Gastrointestinal protective combined therapy segment	~$2.1	2022	[2]
U.S. secondary prevention market	~$750 million	2022	[3]

Note: The global aspirin market is projected to grow at a CAGR of 3-4%, driven by cardiovascular disease prevalence, with the segment for combination therapies expanding due to increasing awareness of GI bleeding risks.

Target Population

• Estimated at 20 million in the U.S. alone at risk for cardiovascular events requiring aspirin therapy.
• Approximately 30-40% concurrently at high risk of GI bleeding (e.g., elderly, patients on anticoagulation).

Regulatory and Clinical Positioning

• Despite the availability of generic aspirin, YOSPRALA offers additional value due to its dual mechanism.
• Broader adoption depends on physician awareness, insurance reimbursement, and comparative benefits over separate co-administration.

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3. Competitive Analysis

Competitors	Key Features	Market Share	Advantages	Limitations
Enteric-coated aspirin	Generic, widely available	Dominates the aspirin segment	Cost-effective	No GI protection, higher bleeding risk
PPI co-prescription + aspirin	Separate medications	Significant	Flexibility, lower medication costs	Lack of fixed-dose convenience
PLAVIX, BRILINTA	Alternatives for antiplatelet therapy	Competitive	Different indications	Not directly substitutable for aspirin
Other combo drugs	Limited	Minimal	N/A	Niche positioning

YOSPRALA's unique proposition is the fixed-dose combination, reducing pill burden and improving compliance among high-risk populations.

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4. Financial Trajectory and Forecasts

Revenue Projections (U.S. Market)

Year	Estimated Revenue (USD million)	Assumptions	Source
2023	85	Initial adoption, physician awareness	Company estimates, market data
2025	150	Increased prescribing, expanded payor coverage	Market growth projections
2027	250	Widespread adoption, possible policy incentives	Trend analysis

Growth Drivers

• Increased cardiovascular disease prevalence
• Growing awareness of GI bleeding risks associated with aspirin
• Potential label expansion for primary prevention indications

Risks & Challenges

• Patent exclusivity expiry (if applicable)
• Competition from generics and new therapies
• Reimbursement barriers impacting adoption

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5. Investment Considerations

Factor	Analysis
Market Penetration	Incremental growth expected; leverage educational campaigns and physician outreach
Regulatory Landscape	Potential for expanded indications; monitor FDA policies
Pricing Strategy	Premium pricing justified by combination benefit; risk of price erosion with generics
Partnership Opportunities	Collaborations with payors, CROs, and distributors
Pipeline Potential	Research into additional combinations or primary prevention indications

6. Policy and Regulatory Environment

• FDA Guidance (2022): Emphasizes cardiovascular safety and GI risk mitigation strategies.
• Coverage Policies: Favorable positioning with payors emphasizing reduced hospitalizations and adverse events.
• Reimbursement Trends: Increasing reimbursement for combination therapies can accelerate adoption.

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7. Comparative Analysis: Benefits over Standard Therapy

Criteria	YOSPRALA	Separate Aspirin + PPI	Generic Aspirin
Pill burden	Single fixed dose	Multiple pills	Single pill
Adherence	Improved	Variable	Variable
Gastrointestinal protection	Yes	No	No
Cost	Higher	Lower	Lowest

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8. Future Outlook and Market Expansion

Strategy Area	Potential Impact	Timeline
Indication Expansion	Primary prevention, broader population	3-5 years
Global Expansion	Key markets: Europe, Asia-Pacific	5-7 years
Formulation Innovations	Extended-release, other combinations	2-4 years
Digital Health Integration	Monitoring adherence, real-world data	1-3 years

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9. Conclusions

YOSPRALA presents a strategically valuable asset within cardiology and gastroenterology markets, especially aimed at patients requiring dual therapy. The drug’s unique fixed-dose formulation promises improved compliance and reduced GI bleeding incidents, underpinning its market growth potential.

However, market success hinges on physician education, reimbursement policies, and competition from established generics. Continuous regulatory engagement and pipeline innovation are critical to sustain and enhance its financial trajectory.

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10. Key Takeaways

• Market Size and Demand: The combined aspirin and PPI therapy market exceeds USD 2 billion, with compound annual growth driven by cardiovascular disease prevalence and GI risk awareness.
• Competitive Edge: Fixed-dose convenience, improved adherence, and GI protection differentiate YOSPRALA from separate co-administration.
• Revenue Outlook: Expect modest growth initially (~15-20% CAGR) with significant upside from indication expansion and global entry.
• Investment Risks: Patent expiration, pricing pressure, and emergence of new therapies require ongoing strategic adaptation.
• Strategic Recommendations: Focus on expanding physician education, leveraging payor partnerships, and exploring pipeline innovations.

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References

1. MarketWatch. “Aspirin Market Overview,” 2022.
2. Grand View Research. "Gastrointestinal Protective Therapies Market," 2022.
3. IQVIA. “U.S. Cardiovascular Drugs Market Data,” 2022.

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FAQs

Q1: What is the primary medical benefit of YOSPRALA compared to traditional aspirin therapy?
A1: YOSPRALA offers dual action—aspirin for antiplatelet effects and esomeprazole for GI bleeding risk reduction—improving adherence and safety.

Q2: How does the patent landscape affect YOSPRALA’s market prospects?
A2: Patent protections provide exclusivity, but expiry would accelerate generic competition, potentially reducing revenue.

Q3: What are the main challenges in expanding YOSPRALA’s global market?
A3: Regulatory approval differences, reimbursement policies, and local clinical practices pose challenges and delay market penetration.

Q4: How does YOSPRALA compare to other combination therapies for cardiovascular prevention?
A4: Its fixed-dose and GI protection offer clinical advantages over separate co-prescription, though price premiums may limit initial uptake.

Q5: Is there potential for YOSPRALA to be used in primary prevention?
A5: Currently approved for secondary prevention; expanded indications would require additional clinical trials and regulatory reviews.

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This detailed analysis underscores YOSPRALA’s promising market position, strategic growth opportunities, and critical factors influencing its investment value in the evolving cardiovascular therapy landscape.