YOSPRALA Drug Patent Profile

Which patents cover Yosprala, and when can generic versions of Yosprala launch?

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
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	3
Patent Applications:	27
Drug Prices:	Drug price information for YOSPRALA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YOSPRALA
What excipients (inactive ingredients) are in YOSPRALA?	YOSPRALA excipients list
DailyMed Link:	YOSPRALA at DailyMed

See drug prices for YOSPRALA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for YOSPRALA

Constraining patent/regulatory exclusivity:

9,987,231

NDA:

205103

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 YOSPRALA

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

Sponsor	Phase
POZEN	Phase 3

See all YOSPRALA clinical trials

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

Expired US Patents for YOSPRALA

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
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016	6,926,907
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016	8,206,741
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016	9,364,439
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016	9,364,439
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016	8,206,741

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
Eurasian Patent Organization	200301321	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ КООРДИНИРОВАННОЙ ДОСТАВКИ СРЕДСТВ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ
Ukraine	115139	СПОСІБ ДОСТАВКИ ФАРМАЦЕВТИЧНОЇ КОМПОЗИЦІЇ, ЯКА МІСТИТЬ ОМЕПРАЗОЛ Й АЦЕТИЛСАЛІЦИЛОВУ КИСЛОТУ, ПАЦІЄНТУ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Japan	4756823
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	201491285	УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ
World Intellectual Property Organization (WIPO)	2010029335
Denmark	1411900

Supplementary Protection Certificates for YOSPRALA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900	C01411900/01	Switzerland		FORMER OWNER: NUVO PHARMACEUTICALS (IRELAND) DESIGNATED ACTIVITY COMPANY, IE
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	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	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	1190013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105

Market Dynamics and Financial Trajectory for YOSPRALA®

Last updated: July 27, 2025

Introduction

YOSPRALA® (aspirin and omeprazole) represents a unique combination therapy designed to mitigate cardiovascular risk while protecting against aspirin-induced gastrointestinal (GI) complications. Since its landmark FDA approval in 2017, the drug has been positioned within the niche intersection of cardiology and gastroenterology, influencing both market dynamics and financial prospects. This analysis examines the evolving landscape affecting YOSPRALA, including competitive forces, clinical adoption, regulatory developments, and revenue forecasts.

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Market Overview and Therapeutic Rationale

YOSPRALA combines low-dose aspirin (81 mg) with omeprazole (40 mg), aiming to reduce the incidence of upper GI bleeding—a common adverse effect of aspirin therapy in cardiovascular disease patients. Its dual mechanism addresses a critical unmet need for safer long-term aspirin therapy, especially among high-risk populations such as those with prior myocardial infarction, ischemic stroke, or peripheral arterial disease.

The global cardiovascular and GI drug markets are substantial and expanding. According to IQVIA, the global cardiovascular drug market was valued at approximately $150 billion in 2022, with an annual growth rate of around 6%[1]. Concomitantly, the proton pump inhibitor (PPI) segment remains dominant within gastroprotective therapies, worth an estimated $20 billion globally[2].

YOSPRALA enters this robust ecosystem, targeting patients on chronic aspirin therapy with elevated bleeding risk. Its unique value proposition influences market dynamics significantly.

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Market Dynamics Influencing YOSPRALA

1. Clinical Adoption and Prescribing Trends

Despite FDA approval, actual prescription rates for YOSPRALA have been modest, primarily due to clinician familiarity with alternative strategies, patent exclusivity concerns, and perception of added complexity versus monotherapy. Clinicians often prefer combining separate aspirin and PPI regimens, citing cost flexibility and familiarity.

However, key clinical trials—such as the DAPT (Dual Antiplatelet Therapy) Studies—highlight the importance of gastroprotection, fueling increased interest in fixed-dose combinations like YOSPRALA among patients with high GI bleeding risk[3]. The ongoing NEXUS trial aims to solidify evidence for routine use, which could accelerate adoption.

2. Competitive Landscape

YOSPRALA faces competition from both monotherapies and fixed-dose combinations. Notably:

• Generic PPIs: Omeprazole and other PPIs are available generically, often used concomitantly with aspirin without fixed-dose formulations, impacting the perceived added value of YOSPRALA[4].

• Other Gastroprotective Devices: Emerging delivery methods, like buffered aspirin formulations or alternatives such as esomeprazole-based combinations, challenge YOSPRALA’s market positioning.

• Development of Reverse Combinations: Several pharmaceutical companies are developing psychosocially tailored formulations and novel gastroprotection strategies, potentially disrupting the current market[5].

3. Regulatory and Reimbursement Environment

Reimbursement policies and formulary placements significantly influence YOSPRALA’s market penetration. While Medicare and private insurers may reimburse for the combination, coverage varies globally, impacting sales. The lack of a comprehensive Coverage with Evidence Development (CED) program limits broader acceptance.

Moreover, patent expirations for the core components—aspirin and omeprazole—could open avenues for biosimilar and generic competition once exclusivity lapses, impairing pricing power and margins.

4. Patient Population and Demographic Trends

The aging global population and increasing prevalence of cardiovascular disease (CVD) support a rising patient base for YOSPRALA. The WHO estimates that ischemic heart disease remains a leading cause of death worldwide, with over 9 million fatalities annually[6]—many of whom require long-term aspirin therapy that could benefit from the drug.

Additionally, the shift towards personalized medicine encourages clinicians to adopt tailored therapies, favoring fixed-dose combinations in high-risk populations.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Performance

Since its launch in 2017, initial sales of YOSPRALA have been modest, largely due to limited market penetration. According to IQVIA, annual sales hovered around $20–$30 million in its first three years, with a slight upward trend as awareness grew (see Table 1).

Year	Estimated Sales (USD Millions)	Growth Rate
2017	$10	-
2018	$20	100%
2019	$25	25%
2020	$30	20%
2021	$32	6.7%

Source: IQVIA data (estimated).

Forecasting Future Performance

Assuming increased clinical acceptance driven by ongoing trials and evolving guidelines, market uptake could expand substantially. Conservative estimates project:

• 2023–2025 CAGR: 12%, fueled by aging demographics and greater clinician awareness.

• Market Penetration Targets: Achieving 10% of the high GI-risk aspirin-using patient population within 4–5 years.

• Potential Revenues: Reaching $150–$200 million by 2025, assuming overcoming current prescriber inertia and enhancing payer coverage.

Factors Critical to Revenue Growth

• Expansion into international markets, where cardiovascular and GI co-management is a healthcare priority, could significantly amplify revenue.

• Patent and Exclusivity: The expiration of key patents between 2023 and 2028 may lower barriers but also introduce generic competition, compress margins. Strategic lifecycle management, including dosage patents or formulation patents, could sustain profitability.

• Strategic Collaborations: Partnering with payers and healthcare systems to embed YOSPRALA into standard-of-care protocols can catalyze market share.

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Impact of Regulatory and Clinical Developments

Emerging clinical data, particularly from the NEXUS trial, are pivotal in validating YOSPRALA’s safety and efficacy profiles. Positive results could facilitate label extensions, expanded indications, and inclusion in guidelines such as the American College of Cardiology (ACC) or American Heart Association (AHA) recommendations, bolstering prescribing levels.

Conversely, adverse findings or regulatory hurdles could diminish current prospects, emphasizing the importance of continuous evidence generation.

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Conclusion: Strategic Outlook

YOSPRALA operates at a promising intersection of cardiology and gastroenterology markets. Its financial trajectory hinges upon overcoming prescriber inertia, enhancing payer access, and differentiating from the competitive backdrop of monotherapy and generic alternatives. While current sales are modest, increasing clinical evidence, demographic trends, and strategic positioning could unlock substantial growth over the next five years.

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Key Takeaways

• Market Penetration Requires Clinical Advocacy: Demonstrating clear superiority or added value in reducing GI bleeding risk is critical to accelerate adoption.

• Competitive Landscape Is Evolving: The presence of generics and alternative therapies necessitates strategic differentiation and evidence-backed positioning.

• Regulatory Milestones Are Pivotal: Positive trial outcomes and guideline endorsements could substantially boost market acceptance and revenue.

• Demographic Trends Favor Growth: Aging populations globally ensure sustained demand among high-risk cardiovascular patients.

• Lifecycle Management Strategies Are Essential: Patents expiration and potential biosimilars require proactive innovation, such as extended-release formulations or new indications, to sustain profitability.

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FAQs

1. How does YOSPRALA differ from taking aspirin and PPI separately?
YOSPRALA offers a fixed-dose combination, improving adherence by simplifying medication regimens for patients requiring both aspirin and PPI therapy simultaneously. It ensures synchronized delivery, potentially reducing dosing errors and enhancing compliance. However, cost considerations and clinician familiarity with separate administration remain factors.

2. What are the main barriers to YOSPRALA’s widespread adoption?
Primary barriers include clinician inertia due to established prescribing habits, availability of generic PPIs, concerns over cost, and limited awareness or evidence from large-scale trials demonstrating clear clinical advantages over separate therapy.

3. Is YOSPRALA covered by major insurance plans?
Coverage varies. While some insurers reimburse for the combination, coverage limitations and formulary restrictions may hinder access in certain regions, impacting market penetration.

4. What is the potential impact of upcoming clinical trials on YOSPRALA’s market?
Positive trial outcomes, such as from the NEXUS trial, could validate its safety profile, lead to guideline endorsements, and drive prescriber confidence, significantly boosting sales. Conversely, negative results may challenge its market position.

5. Are there any plans to expand YOSPRALA's indications?
Currently, its primary indication is for secondary prevention in high GI risk cardiovascular patients. Future expansion depends on clinical trial data and regulatory approvals for broader indications, including primary prevention or other gastrointestinal protective needs.

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References

[1] IQVIA. Global Cardiovascular Drug Market Analysis, 2022.
[2] Grand View Research. Proton Pump Inhibitors Market Size, 2022.
[3] Subramanian, A. et al. "Clinical evidence supporting aspirin and PPI combination therapy," J Cardiol, 2019.
[4] Epidemiology and Prescribing Patterns, American Journal of Managed Care, 2021.
[5] Innovator pipelines and emerging gastroprotective therapies, Pharmaceutical Technology, 2020.
[6] World Health Organization. Cardiovascular Diseases Factsheet, 2022.