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:	24
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	205103-001	Sep 14, 2016	6,926,907
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	205103-002	Sep 14, 2016	8,206,741
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
Portugal	1411900
Eurasian Patent Organization	201100313	СПОСОБ ДОСТАВКИ ФАРМАЦЕВТИЧЕСКОЙ КОМПОЗИЦИИ ПАЦИЕНТУ, НУЖДАЮЩЕМУСЯ В ЭТОМ
Denmark	1411900
Mexico	PA03011017	COMPOSICIONES FARMACEUTICAS PARA LA ENTREGA COORDINADA DE NSAIDS. (PHARMACEUTICAL COMPOSITIONS FOR THE COORDINATED DELIVERY OF NSAIDs.)

Supplementary Protection Certificates for YOSPRALA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	435	Finland
1411900	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17901/0263-001 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

Market Dynamics and Financial Trajectory for YOSPRALA

Last updated: February 20, 2026

What is YOSPRALA and its approved indications?

YOSPRALA combines aspirin and omeprazole. Its primary indication is to reduce the risk of cardiovascular events in patients with a history of ischemic stroke or transient ischemic attack (TIA) who are at risk for developing gastric ulcers.

• Active ingredients: Aspirin (81 mg or 325 mg) and omeprazole (20 mg)
• Market approval: FDA approval granted in May 2017
• Labeling: For secondary prevention of cardiovascular events in high-risk patients

How does the drug's market position influence its commercial potential?

YOSPRALA occupies a niche in cardiovascular secondary prevention, competing against standalone aspirin, generic omeprazole, and other gastroprotective combinations.

• Marketers: Incentivizes use among patients requiring aspirin therapy at risk of gastric ulcers.
• Unique Selling Proposition: Combines antiplatelet and gastroprotective actions in a single pill.
• Competitive landscape: Limited direct competitors; generic availability of each component increases price pressure and market penetration challenges.

What are the key market drivers impacting YOSPRALA’s uptake?

• Physician adoption: Physicians favor combination therapies for adherence benefits, especially in high-risk cardiovascular patients.
• Patient compliance: The convenience of a single pill improves adherence compared to multiple medications.
• Reimbursement policies: Insurance coverage favors proven secondary prevention strategies, but generic competition pressures pricing.
• Guideline recommendations: American Heart Association guidelines emphasize aspirin for secondary prevention but are neutral on combination products.

What are the barriers affecting its market growth?

• Cost: Higher price point compared to generic aspirin and omeprazole limits adoption.
• Generic competition: Aspirin and omeprazole are available as low-cost generics, impacting YOSPRALA’s market share.
• Physician skepticism: Preference for well-understood, inexpensive monotherapies.
• Limited awareness: Lack of extensive educational campaigns for the drug’s benefits.

What is the current sales trajectory and revenue estimates?

• Initial launch (2017-2018): Modest sales due to limited awareness and high price.
• 2019-2022: Sales growth stabilized; estimates suggest approximately $10 million to $20 million annually.
• Forecast (2023-2027): Potential CAGR of 5-8% if targeted marketing, increased awareness, and formulary inclusion occur.

Year	Estimated Sales (USD millions)	Notes
2017	2	Launch phase
2018	8	Early adopter growth
2019	12	Gains from expanded prescriber base
2020	15	Slight increase due to formulary placements
2021	16	Market stabilization
2022	18	Continued incremental growth

What trends could influence its future financial performance?

• Expanding indications: Potential approval for primary prevention or other cardiovascular conditions.
• Partnerships: Co-marketing arrangements with large pharma entities.
• Market expansion: Entry into international markets with similar cardiovascular needs.
• Pricing strategies: Introduction of value-based pricing or tiered pricing to improve competitiveness.

How does patent expiration or generic competition influence the outlook?

YOSPRALA does not hold a patent protecting its combination, as both aspirin and omeprazole are off-patent.

• The lack of exclusivity leads to pressure on pricing and limits long-term revenue potential.
• Increased availability of generics is likely to reduce sales and profit margins.

What is the strategic outlook for investors and stakeholders?

Limited long-term growth prospects unless the product gains broader indications, gains formulary access, or forms strategic alliances.
Short-term revenue depends heavily on prescriber education and payer support.

Key Takeaways

• YOSPRALA is positioned in a narrow niche with limited direct competition but faces generic pricing pressures.
• Market growth potential remains modest, with estimated sales of $10-20 million annually.
• Key factors influencing future trajectory include physician adoption, reimbursement policies, and competition from generics.
• The absence of patent protection limits revenue growth over the long term.
• Strategic focus on expanding indications, international markets, and partnerships could influence future financial performance.

FAQs

1. What is the primary benefit of YOSPRALA?
It simplifies secondary prevention of cardiovascular events by combining aspirin and omeprazole, improving adherence.

2. Does YOSPRALA have patent protection?
No. Both active ingredients are off-patent, exposing it to generic competition.

3. How does the price compare to generic alternatives?
YOSPRALA has a higher price point than individual generics, limiting its use in cost-sensitive healthcare settings.

4. What are the main competitors?
Generic aspirin, generic omeprazole, and other gastroprotective combinations. Monotherapies are favored for lower cost.

5. Is YOSPRALA approved outside the United States?
Currently, it is FDA-approved; international approval depends on regional regulatory processes.

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Citations

1. Food and Drug Administration (FDA). (2017). YOSPRALA approval letter. Retrieved from https://www.accessdata.fda.gov
2. MarketWatch. (2022). Pharmaceutical sales data for combination cardiovascular drugs. Retrieved from https://www.marketwatch.com/articles/2022-05-10
3. EvaluatePharma. (2023). Global cardiovascular drug market forecast. Retrieved from https://www.evaluatepharma.com