PREVACID Drug Patent Profile

Which patents cover Prevacid, and what generic alternatives are available?

Prevacid is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Perrigo Pharma Intl. and is included in six NDAs.

The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.

Summary for PREVACID

US Patents:	0
Applicants:	3
NDAs:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	42
Drug Prices:	Drug price information for PREVACID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREVACID
What excipients (inactive ingredients) are in PREVACID?	PREVACID excipients list
DailyMed Link:	PREVACID at DailyMed

See drug prices for PREVACID

See drug sales revenues for PREVACID

Recent Clinical Trials for PREVACID

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

Sponsor	Phase
Janssen Research & Development, LLC	Phase 1
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
McGill University Health Center	Phase 4

See all PREVACID clinical trials

Pharmacology for PREVACID

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors
Physiological Effect	Inhibition Gastric Acid Secretion

Paragraph IV (Patent) Challenges for PREVACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREVACID	Delayed-release Orally Disintegrating Tablets	lansoprazole	15 mg and 30 mg	021428	1	2006-12-27
PREVACID	Delayed-release Pellets/Capsules	lansoprazole	15 mg and 30 mg	020406		2005-12-05

US Patents and Regulatory Information for PREVACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-001	May 10, 1995		DISCN	Yes	No
Perrigo Pharma Intl	PREVACID 24 HR	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	022327-001	May 18, 2009		OTC	Yes	Yes
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001		DISCN	No	No

Expired US Patents for PREVACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001	5,013,743*PED
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001	4,628,098*PED
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-001	May 10, 1995	5,433,959*PED

International Patents for PREVACID

See the table below for patents covering PREVACID around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H06502194
World Intellectual Property Organization (WIPO)	9959544
Ireland	58363	Pyridine derivatives and their production

Supplementary Protection Certificates for PREVACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0174726	SPC/GB94/011	United Kingdom		SPC/GB94/011, EXPIRES: 20051210
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
0174726	93C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PREVACID

Last updated: July 27, 2025

Introduction

PREVACID (lansoprazole) has been a significant player in the proton pump inhibitor (PPI) market, primarily used for treating gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its lifecycle reflects evolving regulatory landscapes, patent challenges, market competition, and shifting prescribing patterns. This article examines the current market dynamics and forecasts PREVACID's financial trajectory, providing insights critical for investors, healthcare stakeholders, and pharmaceutical strategists.

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Market Overview and Historical Context

Launched in 1995 by Takeda Pharmaceuticals, PREVACID quickly gained prominence as one of the earliest PPIs, catapulting Takeda into a leading position in gastroenterology therapies. Its mechanism of suppressing gastric acid secretion revolutionized the treatment paradigm for acid-related disorders, resulting in broad adoption globally. Over the subsequent decade, PREVACID captured substantial market share among branded PPIs, competing with omeprazole (Prilosec), esomeprazole (Nexium), and pantoprazole (Protonix).

However, patent exclusivity played a pivotal role in shaping its market dynamics. Takeda’s patent for PREVACID expired in the early 2000s in many regions, opening the floodgates to generic competition. This expiration precipitated a sharp decline in sales for the branded version, with generics dominating the cost-sensitive segments.

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Current Market Dynamics

1. Patent Expiration and Generic Competition

The expiration of primary patents for PREVACID led to widespread genericization across key markets such as the United States, Europe, and Japan. Generics, offered at significant discounts, eroded the branded drug’s market share substantially. The presence of multiple manufacturers intensified price competition, further compressing profit margins (as observed in the US, where generic lansoprazole prices reduced by over 70% post-entry).

2. Prescribing Trends and Off-Patent Status

While PPIs remain standard therapy for acid-related disorders, prescribing behaviors have shifted. Both clinicians and formulary managers increasingly favor generic PPIs due to cost-effectiveness, diminishing the market for branded PREVACID. Despite clinical advantages claimed for certain brands, evidence-driven guidelines tend to favor well-established generics, pressuring PREVACID's market position.

3. Market Consolidation and Strategic Alliances

Takeda has sought to sustain revenue streams from PREVACID through licensing agreements, over-the-counter (OTC) formulations, and alternative delivery methods. The OTC status of lansoprazole in several regions allows for over-the-counter sales, supporting brand presence in primary care and retail environments, but at lower margins compared to prescription use.

4. Regulatory and Patent Litigation

Legal challenges from generic manufacturers and patent holders influence PREVACID’s market lifespan. Takeda engaged in patent litigation, with some patents upheld, delaying generic entry, but most patents have now expired, leaving the market entirely open to generics.

5. Competitive Landscape

The competitive environment comprises several successful PPIs with differentiated profiles, such as Nexium (esomeprazole) and Dexilant (dexlansoprazole). While these drugs command premium pricing in branded form, their market share is limited by higher costs and patent exclusivity. The entry of over-the-counter formulations and cheap generics has further constrained PREVACID’s revenue potential.

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Financial Trajectory and Forecast

1. Revenue Decline Post-Patent Expiry

Following patent expiration, Takeda's revenues from PREVACID sharply declined due to generic erosion. Data from financial reports indicate an approximate 70-80% drop in sales within five years of patent expiry. As of 2022, PREVACID’s contribution to Takeda’s revenue dwindles to a minimal fraction, reflecting generic dominance.

2. Transition to Over-the-Counter (OTC) Sales

The OTC pathway offers an alternative revenue stream but with limited margins. OTC formulations typically generate lower profits, and their dominance is challenged by direct-to-consumer advertising, OTC market saturation, and competition from other OTC PPIs like omeprazole.

3. Ongoing Patent and Regulatory Challenges

Any residual patent protections provide only temporary shields, with expirations anticipated or already occurred in key markets. This marginally prolongs the profitability window but is unlikely to reverse the overarching decline trend.

4. Strategic Divestment and Portfolio Focus

Takeda’s strategic focus has shifted toward specialty pharmaceuticals. Sale of assets related to early-stage drugs or OTC lines, along with pipeline investments, suggests minimal re-investment in PREVACID. The financial outlook appears to favor reduced investment, with the drug moving towards a mature or declining revenue status.

5. Future Outlook

Given current patent landscapes and market conditions, PREVACID is expected to follow a continued decline trajectory. Minor growth might be possible through niche markets, OTC sales, or formulation improvements, but substantial revenue contributions are unlikely. The drug is approaching end-of-life in terms of commercial significance within a decade unless new indications or formulations are developed.

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Market Growth Drivers and Constraints

Growth Drivers

• Generic Penetration: Continual availability of low-cost generics sustains PPIs as first-line therapies.
• Expanding Indications: New or off-label uses could temporarily bolster demand.
• Over-the-Counter Expansion: Increased OTC sales in emerging markets may offer incremental revenue.

Constraints

• Pricing Compression: Heavy generic competition suppresses prices.
• Market Saturation: Most patients with acid disorders already on therapy.
• Regulatory and Patent Barriers: Limit expansion and innovation avenues.

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Strategic Implications for Stakeholders

For pharmaceutical companies, PREVACID exemplifies the importance of lifecycle management strategies post-patent expiry. Diversification into new formulations, indications, or delivery methods could prolong viability. Clinicians and payers must prioritize cost-effective therapies, favoring generics over branded drugs.

Investors and analysts should discount PREVACID’s revenue forecasts proportionally to its patent and generic erosion timeline. The asset's value is predominantly historical, with incremental gains limited to niche or OTC markets.

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Key Takeaways

• Patent expiration has fundamentally shifted PREVACID’s market from branded to generic dominance, triggering a steep revenue decline.
• Market saturation, along with cost-driven prescribing trends, constrains the drug’s growth potential.
• OTC formulations and niche indications offer limited revenue opportunities amid the broader generic landscape.
• Future prospects hinge on lifecycle management, alternative formulations, and innovation, but are limited by patent expirations and market competition.
• Stakeholders should focus on cost-effective PPI therapies, anticipating continued price compression and declining branded sales of PREVACID.

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FAQs

1. When did PREVACID’s primary patents expire, and what was the impact?
PREVACID’s patent primarily expired in the early 2000s in key markets. The expiration led to rapid generic entry, significantly reducing sales of the branded drug by over 70% within five years.

2. How does PREVACID compare to other PPIs in the current market?
While PREVACID remains available, it faces stiff competition from low-cost generics and other branded PPIs like Nexium and Prilosec. Price and formulary preferences favor generics, limiting PREVACID's market share.

3. Are there ongoing patent protections that could extend PREVACID's lifecycle?
Most patents have expired globally, with only residual protections potentially affecting specific formulations or delivery methods. These are unlikely to substantially prolong market presence.

4. What role does OTC availability play in PREVACID’s current economic model?
OTC formulations provide an alternative revenue stream but at lower margins and limited growth potential compared to prescription sales during patent exclusivity.

5. What strategies could prolong PREVACID’s commercial viability?
Potential strategies include reformulation, developing new indications, or niche marketing. However, these are constrained by patent landscapes, market saturation, and high competition.

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References

[1] Takeda Pharmaceuticals Annual Reports, 2000–2022.
[2] U.S. Food and Drug Administration (FDA) Patent and Exclusivity Data.
[3] IMS Health (IQVIA) Market Reports on PPIs.
[4] Factiva and industry analysis reports on generic drug market dynamics.