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	205103-001	Sep 14, 2016	9,364,439
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	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
Austria	474559
Australia	2002305758
Australia	2006235929	Pharmaceutical compositions for the coordinated delivery of NSAIDs
Australia	2009200966	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	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	91858	Luxembourg		91858, EXPIRES: 20251105
1411900	1190013-1	Sweden		PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900	CA 2012 00036	Denmark

Last updated: July 30, 2026

Yosprala (Aspirin/Omeprazole) Market Dynamics and Financial Trajectory (Sales, Uptake, and Competitive Pressure)

Yosprala (aspirin/omeprazole) is a fixed-dose, enteric-coated aspirin plus proton-pump inhibitor product positioned in secondary cardiovascular prevention. Its market trajectory has been shaped by (1) long-running generic aspirin dominance, (2) brand and generic erosion in proton-pump inhibitors, and (3) payer scrutiny focused on whether the combination meaningfully improves adherence and reduces GI events versus generic aspirin plus generic omeprazole. Yosprala’s commercial performance is also constrained by its limited label scope and physician preference for separate generics.

Bottom line: competitive economics strongly favor generic co-therapy (generic aspirin + generic omeprazole) and discounting pressure on the fixed-dose combination. Sales growth, when observed, has depended on formulary access, copay positioning, and cardiology and GI prescribing adoption rather than exclusivity-driven expansion.

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What is the commercial profile of Yosprala (aspirin/omeprazole) and how does it fit cardiovascular prevention?

Quick read: Yosprala targets patients who require low-dose aspirin for cardiovascular risk reduction and have GI-risk considerations that motivate concomitant acid suppression. The commercial value proposition is simplified dosing and potential GI protection versus aspirin alone.

What patient population does Yosprala address?

Yosprala is used for secondary prevention in patients who need:

• low-dose aspirin therapy for cardiovascular protection
• acid suppression to mitigate upper GI irritation and ulcer risk

How does the combination compete with standard-of-care alternatives?

The competitive set is not a single drug. The relevant alternatives are:

• Generic low-dose aspirin alone
• Generic aspirin + generic omeprazole co-therapy
• Other gastroprotection strategies used with aspirin (including other PPIs), depending on formulary

This matters for market dynamics because generics compress willingness to pay for fixed-dose combinations unless payers view the combination as cost-neutral or adherence-improving.

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How do payer decisions and formulary placement drive Yosprala sales dynamics?

Featured snippet answer: Yosprala’s revenue trajectory is mostly a function of formulary access for a branded PPI-based combination layered on a generic-dominated aspirin class.

What are the key payer levers impacting Yosprala?

• Preferred status vs non-preferred: branded fixed-dose combinations typically face higher step edits.
• Copay and coverage rules: manufacturer-funded copay support affects near-term scripts but can be offset by plan edits.
• Clinical-policy gating: some plans require documentation of GI risk or prior ulcer/bleed history.
• “Generic substitution” logic: payers often treat aspirin plus a generic PPI as an interchangeable strategy.

Why does formulary dynamics matter more than differentiators?

Even when the combination improves adherence, the economic comparison is usually against:

• generic aspirin (very low cost)
• generic omeprazole (low cost)
• clinicians can prescribe both separately

So Yosprala must secure pricing and coverage that are competitive relative to the generic baseline.

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When does Yosprala face exclusivity pressure, and how does timing impact revenue?

Featured snippet answer: The brand’s long-run financial trajectory is dominated by exclusivity end points and the inability to insulate against generic aspirin and generic omeprazole co-therapy.

How do exclusivity and patent life typically translate into sales curves here?

In fixed-dose combination brands with generic components:

• patent expiration can accelerate direct generic competition if a substitute is approved and launched
• even without direct generic substitution, sales can flatten if payer guidelines steer to generic co-therapy
• timing of FDA approvals for potential competitors influences near-term script share

Revenue inflection drivers to watch

• launch or approval of “authorized” generics or direct AB-rated combination products (if any)
• payer updates that reclassify aspirin+PPI co-therapy as the preferred regimen
• increased utilization of once-daily generic PPI alternatives

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What competitive landscape risks exist for Yosprala versus generic aspirin plus omeprazole?

Featured snippet answer: The biggest structural risk is that the combination is economically undercut by two inexpensive generics that clinicians can prescribe together.

Key competitive vectors

1. Pricing compression: branded combination pricing must remain meaningfully below the “brand premium” relative to generic co-therapy.
2. Prescriber default behavior: cardiology and primary care often use simple generic aspirin plus a generic PPI if GI risk exists.
3. PPI portfolio switching: formulary PPIs change; if omeprazole is not preferred, the combination’s relative advantage can weaken.
4. GI risk management substitutes: in some systems, clinicians shift to alternative gastroprotection approaches based on internal protocols.

How strong is the risk that Yosprala loses scripts?

If payers enforce a “generic co-therapy equivalency,” Yosprala must win on coverage and copay. Without that, script volume tends to drift toward generic aspirin + generic PPI.

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What is the Orange Book status for Yosprala and how does it map to financial exposure?

Featured snippet answer: Yosprala’s economic exposure depends on whether it has patent-protected exclusivity as a fixed-dose combination and whether competitors can launch AB-rated versions that displace the brand.

What the Orange Book typically tells investors

• whether Yosprala has listed patents tied to the active ingredient combination, formulation, or method
• whether competing applicants have Paragraph IV certifications
• timing of potential generic launches

How to connect Orange Book events to revenue

• a near-dated potential generic entry usually drives pricing and promotional intensity changes
• litigation outcomes can force delayed launches or reshape settlement economics
• FDA pathway decisions can shift entry risk from “known” to “unexpected”

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What generic entry risks exist for Yosprala, including Paragraph IV and settlements?

Featured snippet answer: Generic entry risk is materially higher if a competitor pursues a fixed-dose combination approval that can be substituted at the pharmacy.

What to look for in generic entry scenarios

• AB-rated ANDA approval or tentative approval timing
• Paragraph IV litigation if patents are challenged
• settlement terms (delayed launch, design-around, revenue sharing, or other covenants)

Why settlements can still depress revenue

Even when direct competition is delayed, a settlement often signals:

• management anticipates erosion
• payers start renegotiating pricing
• clinicians shift in anticipation of lower-cost options

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How does Yosprala compare with other aspirin plus PPI strategies on market economics?

Featured snippet answer: Market economics favor the strategy that is cheapest and easiest to access, which is usually generic aspirin plus a preferred generic PPI.

Fixed-dose combination vs co-therapy (economic comparison)

• Fixed-dose combo: higher net price risk, depends on coverage and copay.
• Co-therapy: usually lower cost; prescribers can personalize PPI selection based on formulary.

Where Yosprala can win commercially

• patients with adherence issues benefiting from fewer pills
• health systems favoring the branded combination for protocol standardization
• payer contracts that price Yosprala competitively to generic co-therapy

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What FDA and commercialization milestones affect Yosprala uptake?

Featured snippet answer: Uptake depends on prescribing adoption after approval, stable labeling interpretation, and whether FDA communications or safety-related updates affect comfort with ongoing use.

Key commercialization milestones to monitor

• label expansion or safety communication changes that affect GI-risk targeting
• changes in FDA-approved labeling that affect who can be prescribed
• postmarketing safety patterns that influence formulary preference

(Commercially, these affect retention and persistence more than first-year adoption.)

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What is the likely revenue trajectory shape for Yosprala based on class economics?

Featured snippet answer: The trajectory typically shows either slow growth to a plateau or early growth followed by flattening as payers normalize generic alternatives.

Expected trajectory mechanics

• early period: brand awareness, sampling, physician adoption, coverage gains
• mid period: payer pushback and competitive generic co-therapy expansion
• later period: discounts intensify; scripts shift based on coverage changes

Investment implication

For combination products built on generic cores, revenue risk is less about new-to-market demand and more about maintaining net price and formulary positioning.

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Key Takeaways

• Yosprala’s market dynamics are dominated by generic economics: low-dose aspirin and omeprazole are both cost-advantaged, making generic co-therapy the default comparator.
• Sales trajectory is driven by formulary access, copay strategy, and whether plan design treats the fixed-dose combination as interchangeable with generic aspirin plus a generic PPI.
• Revenue inflection risk concentrates around fixed-dose combination substitution events, Orange Book/patent challenges, and payer policy updates that steer toward generics.
• Long-run growth is constrained unless Yosprala secures persistent preferred coverage or contracted pricing that neutralizes the generic baseline.

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FAQs

1) Why do fixed-dose aspirin plus PPI combinations struggle to sustain growth versus separate generics?

Because pharmacy substitution economics and payer policies favor prescribing the lowest-cost components separately, limiting the brand’s ability to command a premium.

2) What formulary design most increases the likelihood of Yosprala script growth?

Preferred tier placement, favorable prior authorization criteria, and copay support that reduces patient cost-sharing relative to generic co-therapy.

3) How do PPI switching patterns affect Yosprala competitiveness?

If a payer prefers a different PPI than omeprazole, the fixed combination can lose value versus selecting the preferred PPI with generic aspirin.

4) What is the biggest risk to Yosprala net sales during patent or FDA-related events?

Even when direct generic competition is delayed, payer and prescriber behavior can shift in anticipation, pressuring net pricing before launch.

5) How should investors interpret plateauing volume for Yosprala?

Plateauing often reflects attainment of maximum feasible formulary reach rather than saturated clinical demand, given the ease of using aspirin plus a generic PPI.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval and Related Documents for Yosprala (aspirin/omeprazole). U.S. Food and Drug Administration.