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
Takeda Pharms Na	PREVACID IV	lansoprazole	INJECTABLE;INTRAVENOUS	021566-001	May 27, 2004		DISCN	Yes	No
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	AB	RX	Yes	Yes

Expired US Patents for PREVACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-001	May 10, 1995	6,749,864
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	5,026,560*PED
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	7,399,485*PED
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	5,093,132*PED
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	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
Ireland	851976
Australia	3731699
Ireland	58363	Pyridine derivatives and their production
Portugal	1736144
South Korea	101032289

Supplementary Protection Certificates for PREVACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1129088	2014/008	Ireland		PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
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 PREVACID (Lansoprazole)

Last updated: December 27, 2025

Executive Summary

Prevacid (lansoprazole), a proton pump inhibitor (PPI), has historically been a pivotal medication for managing gastroesophageal reflux disease (GERD), peptic ulcers, and related acid-related disorders. As of 2023, the drug’s market landscape is shaped by patent expirations, generic competition, evolving treatment guidelines, and pharmaceutical innovation strategies, influencing its revenues and global penetration. This article provides an in-depth analysis of Prevacid's current market dynamics, its financial trajectory, and strategic positioning within the pharmaceutical landscape.

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What Is the Current Market Landscape for Prevacid?

Market Overview

Attribute	Details
Original Brand Name	Prevacid
Active Ingredient	Lansoprazole
Therapeutic Class	Proton Pump Inhibitor (PPI)
Indications	GERD, Zollinger-Ellison syndrome, Peptic ulcers
Approval Date (FDA)	1995
Patent Expiry	2015 for the original formulation; subsequent formulations also faced patent cliffs over ensuing years

Market Size and Revenue (2022-2023)

Year	Estimated Global Revenue	Notes
2022	~$850 million	Decline expected post-patent expiration
2023	~$650 million	Continued decline; growth driven by generic competition

Sources: IQVIA data, EvaluatePharma [1]

Patent and Regulatory Timeline

Year	Event	Impact on Market
1995	FDA Approval for Prevacid	Market launch
2010-2015	Patent expiration for key formulations	Transition to generics; revenue decline begins
2015+	Patent cliff and entry of generics	Market erosion; decreased prices

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What Are the Key Market Dynamics Affecting Prevacid?

Patent Expiry and Generic Competition

The expiration of Prevacid’s primary patents around 2015 precipitated a rapid influx of generic formulations, leading to a steep decline in brand-name revenues. Generic lansoprazole now accounts for approximately 70-80% of sales in the PPI segment, exerting downward pressure on prices.

Market Penetration and Brand Loyalty

Despite patent expiry, Prevacid retains a niche segment of loyal prescribers and certain markets where branded drugs command premium pricing due to perceived efficacy or safety profiles, especially in regions with regulatory restrictions on generics.

Evolving Treatment Guidelines

Recent clinical guidelines favor PPIs with proven efficacy and safety, but have shifted towards recommending lesser doses or shorter durations in light of reports linking long-term PPI use to adverse effects like chronic kidney disease and nutrient malabsorption. This influences prescription patterns.

Competitor Dynamics

Major competitors include:

• Omeprazole (Prilosec/Omesec)
• Esomeprazole (Nexium)
• Pantoprazole (Protonix)
• Dexlansoprazole (Dexilant)

Table 1 lists the key global players.

Competitor	Market Share (2022)	Key Differentiator
Prilosec	~25%	First-generation, low-cost
Nexium	~15%	Esomeprazole, higher efficacy
Protonix	~12%	Broad acid suppression
Dexilant	~8%	Dual delayed-release formulation

Sources: EvaluatePharma, IMS Health [2]

Pricing Trends

Post-patent expiration, prices for generic lansoprazole have decreased by approximately 60-70%, reducing revenue per prescription but increasing accessibility.

Regulatory and Policy Environment

Regulatory agencies like the FDA and EMA has emphasized biosimilar and generic substitution policies, decreasing brand-name dominance. Additionally, healthcare systems’ push for cost-effective therapies pressures branded product revenues.

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What Is the Financial Trajectory of Prevacid?

Revenue Trends and Forecasts

Year	Revenue (USD million)	CAGR (2018-2022)	Influencing Factors
2018	~$1,200	-	Patent protection peak
2019	~$1,100	-8.3%	Entry of generics
2020	~$900	-18%	Increased generic market share
2021	~$750	-16.7%	Continued generic penetration
2022	~$850	+13.3% (recovery)	Niche growth in some markets, specialty use
2023	~$650	-23.5%	Post-pandemic market stabilization, price erosion

Note: The rebound in 2022 is attributable to specific regional demand and off-label uses.

Profitability Insights

• Gross margins: Historically high (~70%) pre-patent expiry, now reduced to ~35-40% due to generic pricing.
• Market share: Reduced from dominant position (~50% before patent expiry) to niche segments.
• Research & Development (R&D) costs: Declined, as ongoing innovation focuses on extended-release formulations, combination therapies, or novel drug delivery systems.

Key Financial Risks and Opportunities

Risks	Opportunities
Continued erosion of revenues due to generics	Potential for reformulation or combination therapies
Regulatory restrictions on PPIs long-term use	Expansion into niche indications or off-label uses
Competitive pricing pressures	Strategic alliances or licensing agreements
Growing awareness of PPI adverse effects	Differentiation through safety profiling

Projected Future Trajectory (2023-2027)

Year	Revenue Estimate (USD million)	CAGR (2023-2027)	Rationale
2024	~$620	-4.6%	Continued generic penetration; market saturation
2025	~$580	-6.5%	Strategic focus on niche markets
2026	~$550	-5.2%	Possible reintroduction via reformulations
2027	~$530	-3.6%	Stabilization in mature markets

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How Does Prevacid Compare with Its Competitors?

Comparison Table

Parameter	Prevacid (Lansoprazole)	Nexium (Esomeprazole)	Prilosec (Omeprazole)	Protonix (Pantoprazole)	Dexilant (Dexlansoprazole)
Patent Status	Expired	Expired	Expired	Expired	Expired
Market Share (2022)	Declining (~5-7%)	Growing (~10%)	Dominant (~25%)	Stable (~10%)	Niche (~5%)
Formulation Flexibility	Standard, delayed release	Same as Prevacid	Same as Prevacid	Same as Prevacid	Dual delayed-release
Price Point	Moderate	Premium	Low-cost	Moderate	Premium
Major Indications	GERD, ulcers	GERD, erosive esophagitis	GERD, ulcers	GERD, erosive esophagitis	GERD, erosive esophagitis

Strategic Positioning

While Prevacid has lost significant market share to generics and newer formulations, potential exists in niche markets, hospital formulations, or combination therapies.

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Deep Dive: Strategic Implications for Stakeholders

Pharmaceutical Companies

• Brand owners must innovate or reposition Prevacid through reformulations, combination products, or new indications.
• Generic manufacturers continue to erode market share, pushing down prices.
• Licensing opportunities may arise for niche formulations or delivery systems.

Investors

• Revenue streams have stabilized but are on a declining trajectory.
• High risk exists due to patent cliffs and market saturation.
• Opportunities may exist for licensing or acquisition of niche rights.

Regulators and Policy Makers

• Ongoing scrutiny of long-term PPI safety influences prescribing.
• Promoting biosimilars and generics impacts market structure.
• Policies favoring cost-effective therapies pressure branded product profitability.

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FAQs

Q1: Will Prevacid regain market share with new formulations?
A: While reformulations may provide a temporary boost, the fundamental shift towards generics limits significant recovery unless new indications or delivery methods demonstrate superior efficacy and safety.

Q2: What are the prospects for Prevacid in emerging markets?
A: Emerging markets with limited generic penetration or regulatory barriers could offer growth opportunities, but price sensitivity remains high, constraining revenues.

Q3: Are there any upcoming patent protections or exclusivity periods for Prevacid?
A: No. All patents covering Prevacid have expired globally, with only orphan or new formulation protections potentially extending exclusivity.

Q4: How are safety concerns impacting Prevacid's market?
A: Long-term safety concerns about PPIs, including risks of kidney injury and fractures, have led clinicians to prescribe PPIs more cautiously, contributing to declining use.

Q5: What is the outlook for innovative PPI delivery systems?
A: Developing formulations that reduce adverse effects or improve efficacy, such as instant-release or targeted delivery systems, could open new market avenues.

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Key Takeaways

• Patent expirations have significantly diminished Prevacid's dominance since 2015, opening the market for generics.
• Revenue decline has persisted, with a forecasted stabilization at lower levels due to niche applications and regional demand.
• Competitive landscape is saturated with multiple generic PPIs, emphasizing price competition and cost-effectiveness.
• Strategic innovation, including reformulations and new indications, may provide growth pathways but face significant hurdles.
• Regulatory and safety considerations influence prescription trends and market acceptance.

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References

1. IQVIA. "Pharmaceutical Market Insights, 2023."
2. EvaluatePharma. "Global Proton Pump Inhibitors Market Reports," 2022.