Lansoprazole - Generic Drug Details

What are the generic drug sources for lansoprazole and what is the scope of freedom to operate?

Lansoprazole is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Novitium Pharma, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt Bio Ag, Xiromed, Zydus Hlthcare, Takeda Pharms Usa, Perrigo Pharma Intl, Takeda Pharms Na, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, and Zydus Pharms, and is included in thirty-seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lansoprazole has three patent family members in three countries.

There are fifty-six drug master file entries for lansoprazole. Sixty-seven suppliers are listed for this compound.

Summary for lansoprazole

International Patents:	3
US Patents:	2
Tradenames:	7
Applicants:	31
NDAs:	37
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	67
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	193
Patent Applications:	7,200
Drug Prices:	Drug price trends for lansoprazole
Drug Sales Revenues:	Drug sales revenues for lansoprazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lansoprazole
What excipients (inactive ingredients) are in lansoprazole?	lansoprazole excipients list
DailyMed Link:	lansoprazole at DailyMed

See drug prices for lansoprazole

See drug sales revenues for lansoprazole

Recent Clinical Trials for lansoprazole

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

Sponsor	Phase
National Taiwan University Hospital	PHASE2
Cinclus Pharma Holding AB	PHASE3
Assiut University	PHASE3

See all lansoprazole clinical trials

Pharmacology for lansoprazole

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

Medical Subject Heading (MeSH) Categories for lansoprazole

Anti-Ulcer Agents

Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lansoprazole

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for LANSOPRAZOLE

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 lansoprazole

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	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	AB	RX	Yes	Yes
Zydus Pharms	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	200816-001	Nov 27, 2018	AB	RX	No	No
Inventia	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	205868-001	Aug 30, 2017	AB	RX	No	No
Mylan	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	202396-002	Nov 28, 2018	AB	RX	No	No

Expired US Patents for lansoprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	6,749,864
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001	6,749,864
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	6,328,994*PED
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	7,399,485*PED

International Patents for lansoprazole

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016174664
European Patent Office	3288556	COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS)
Israel	255048	הרכבים המתפוררים בפה (Orally disintegrating compositions)
Israel	255048	הרכבים המתפוררים בפה (Orally disintegrating compositions)

Supplementary Protection Certificates for lansoprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0174726	93C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211
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
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

Market Dynamics and Financial Trajectory for Lansoprazole: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

Lansoprazole, a proton pump inhibitor (PPI) primarily used to treat gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger-Ellison syndrome, has established itself as a significant entity within the global pharmaceutical landscape. Market forces, regulatory trajectories, patent statuses, and competitive landscapes jointly shape its commercial and financial trajectory. This article explores these dynamics, projecting future market prospects and delineating key factors influencing Lansoprazole's financial outlook.

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Market Overview and Therapeutic Positioning

Lansoprazole, initially approved by the U.S. Food and Drug Administration (FDA) in 1995, commands a notable share in the PPI segment, which itself holds a dominant position in acid-related disorder therapies. The global demand for acid suppression drugs is driven by increasing prevalence rates of GERD and related conditions, as well as rising awareness of gastrointestinal health.

The therapeutic efficacy and safety profile of Lansoprazole have historically led to broad prescription acceptance, especially in developed markets. However, regulatory and patent landscapes impact the system's sustainability and competitive positioning.

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Market Dynamics

1. Patent Expirations and Generics Entry

A pivotal factor influencing Lansoprazole's market valuation is patent expiration. Pfizer's original patent for Lansoprazole expired in multiple jurisdictions around 2010–2012, paving the way for generic competitors. This significantly eroded the drug’s branded pricing power, leading to a sharp decline in revenue from the original formulation.

The proliferation of generic versions has increased affordability and widened access, yet intensified price competition. Generic manufacturers typically price Lansoprazole at a substantial discount—often 20–40% less than branded counterparts—substantially impacting profit margins for originators.

Impact: Generic penetration has led to a decline in overall sales for branded Lansoprazole but broadened drug accessibility, boosting volume sales globally.

2. Market Penetration and Prescription Trends

Despite generic competition, Lansoprazole maintains a core market share, notably in regions with less extensive generic penetration or where physicians favor the original formulation due to perceived efficacy or safety. Prescription trends in emerging markets continue to evolve as healthcare infrastructure improves, creating additional avenues for growth.

Certain formulations and combination therapies with antibiotics or other agents sustain niche demand, particularly for Helicobacter pylori eradication protocols.

Impact: Volume-based sales remain a significant revenue component, even as per-unit prices decline.

3. Regulatory and Patent Strategies

Pharmaceutical companies employ patent strategies and market exclusivity to delay generic entry. Recent complex formulations, or new delivery mechanisms such as delayed-release formulations, can extend exclusivity periods artificially.

Regulatory hurdles—such as approval of biosimilars or over-the-counter (OTC) status—also influence market dynamics. Some markets increasingly reclassify PPIs for OTC availability, impacting prescription volumes and revenue.

Impact: Strategic patent management and regulatory pathways continue to influence Lansoprazole’s market trajectory, with potential for phased growth or decline depending on regional policies.

4. Competitive Landscape

Besides generics, PPIs like omeprazole, esomeprazole, pantoprazole, and rabeprazole vie for market share. The minor pharmacokinetic differences among these agents influence prescribing habits, especially when considering safety profiles or drug-drug interactions.

Developments in novel therapies, including potassium-competitive acid blockers (P-CABs), threaten the traditional PPI market segment, potentially constraining future growth.

Impact: The competitive pressure constrains pricing power and necessitates differentiation strategies for stable revenues.

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Financial Trajectory and Revenue Projections

Historical Revenue Trends

Pfizer’s Lansoprazole sales peaked in the early 2000s, prior to patent expiration, reaching hundreds of millions annually. Post-generic entry, revenues declined precipitously. Industry estimates suggest that the global Lansoprazole market was valued at approximately USD 1.5 billion in 2010, decreasing to below USD 300 million by 2020 for the original branded product.

Emerging markets have stabilized or even slightly increased demand, attributing to lower drug prices and expanding healthcare access.

Future Market Outlook

Forecasting the future entails analyzing several variables:

• Generic Penetration and Competition: Continued dominance of generics is expected unless branded reformulations re-enter the market with superior benefits or patents are reinstated.
• Regional Market Dynamics: Growth in Asia-Pacific and Latin America, driven by healthcare expansion, could offset declines in mature markets.
• Pipeline and Reformulations: Innovations such as vacated patent pathways for novel formulations or combination therapies could revive revenues.
• Regulatory Changes: Transition of Lansoprazole to OTC in developed markets might reduce prescription revenues but increase OTC sales volumes, potentially stabilizing total revenue streams.

Projected Revenue Range: Based on current industry analyses, the global market for Lansoprazole and its equivalents is projected to stabilize or experience modest growth at a compound annual growth rate (CAGR) of 1–3% over the next five years, primarily driven by emerging markets.

Implications for Stakeholders

Pharmaceutical companies need strategic patent management, formulation innovation, and market segmentation to sustain profitability. Market entrants should focus on low-cost manufacturing, especially in regions with high demand for generic PPIs. Healthcare policy shifts toward OTC availability can redefine revenue models, emphasizing volume over premium pricing.

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Regulatory and Competitive Risks

Increasing regulatory scrutiny over PPIs concerning long-term safety issues—such as potential risks for renal disease and fractures—may influence prescribing habits and reimbursement policies, potentially tempering sales growth. Moreover, the advent of P-CABs, which offer faster and potentially more durable acid suppression, poses a competitive threat.

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Key Market Drivers and Restraints

Drivers	Restraints
Rising prevalence of acid-related gastrointestinal conditions	Patent expiries and aggressive generic pricing
Increased healthcare access in emerging markets	Market saturation and narrow profit margins
Technological innovations extending patent life	Safety concerns impacting prescribing patterns
Development of alternative therapies (P-CABs)	Regulatory hurdles and OTC reclassification trends

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Key Takeaways

• Lansoprazole’s commercial landscape has been profoundly shaped by patent expirations, leading to a shift from branded revenues to volume-driven generic sales.
• The global Lansoprazole market is experiencing a transitional phase characterized by intense price competition but sustained demand in emerging markets.
• Strategic formulations, patent management, and regional market expansion remain critical for stakeholders seeking financial resilience.
• Innovation, including formulations with enhanced efficacy or safety profiles, presents potential avenues for revenue stabilization.
• Regulatory shifts and the emergence of novel acid-suppressive therapies will continue to influence competitive positioning and profitability.

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FAQs

1. How has patent expiry impacted Lansoprazole’s market share?
Patent expiry led to widespread generic entry, significantly reducing the original product's market share and pricing power, transitioning revenues from branded to generic sales predominantly.

2. What are the primary regions driving future demand for Lansoprazole?
Emerging markets in Asia-Pacific and Latin America are expected to sustain or increase demand due to expanding healthcare infrastructure and affordability.

3. Are there potential alternatives threatening Lansoprazole's market?
Yes. P-CABs like Vonoprazan offer faster, more durable acid suppression, posing competitive threats to traditional PPIs including Lansoprazole.

4. What strategies can pharmaceutical companies employ to maintain revenues?
Innovative formulations, extending patent exclusivity through new delivery systems, expanding OTC availability, and market diversification are key strategies.

5. How might regulatory developments affect Lansoprazole’s future?
Regulatory restrictions based on safety concerns and shifts toward OTC status could reduce prescription revenues but may expand overall market volume.

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Conclusion

Lansoprazole's market and financial trajectory reveal a complex interplay between patent climates, generic competition, regional healthcare dynamics, and therapeutic innovations. While revenue pressures have intensified post-expiry of patent exclusivity, strategic adaptation through formulation innovation and market expansion can sustain its relevance. Stakeholders must remain vigilant to regulatory developments and emerging therapies to optimize their positioning in this evolving landscape.

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References

[1] GlobalData. "Proton Pump Inhibitors Market Analysis," 2022.
[2] IQVIA. "Pharmaceutical Market Report," 2022.
[3] U.S. Food and Drug Administration. "Lansoprazole Approval History," 1995.
[4] Statista. "Pharmacoeconomic Trends in Acid Suppressants," 2022.
[5] MarketWatch. "Generic Drug Market Dynamics," 2022.