Lansoprazole - Generic Drug Details

What are the generic drug sources for lansoprazole and what is the scope of patent protection?

Lansoprazole is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, 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, 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-five 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:	65
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	198
Patent Applications:	7,332
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
Stanford University	PHASE2
Tanta University	PHASE2
Tanta 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 Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001		DISCN	No	No
Macleods Pharms Ltd	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	208671-002	Nov 4, 2024		DISCN	No	No
Teva Pharms Usa	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208784-002	Sep 21, 2017	AB	RX	No	No
Ani Pharms	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	078730-002	Oct 15, 2010		DISCN	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	021428-002	Aug 30, 2002	7,399,485*PED
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	6,749,864
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001	5,433,959*PED
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	7,875,292*PED

International Patents for lansoprazole

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

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
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
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

Market Dynamics and Financial Trajectory for Lansoprazole

Last updated: February 19, 2026

What Are the Key Market Drivers for Lansoprazole?

Lansoprazole, a proton pump inhibitor (PPI), is used primarily for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its market is influenced by several factors:

• Growing prevalence of GERD and acid-related disorders. An estimated 20% of adults in the U.S. experience GERD symptoms annually (Katz et al., 2021). Similar trends exist globally, expanding the patient base.
• Shift toward prescription medications over over-the-counter (OTC) options. Many formulations of lansoprazole transitioned to OTC status, which expanded sales volume but limited revenue growth potential in prescription markets.
• Patent expirations. The original patent for the branded version expired in 2013, leading to increased generic competition. Generics now dominate the market, reducing prices but increasing overall volume.
• Emergence of new therapies. Drugs like vonoprazan, a potassium-competitive acid blocker (P-CAB), threaten the market share of traditional PPIs, including lansoprazole.

How Does Patent Expiration Impact Lansoprazole’s Market?

The expiration of patent rights for branded lansoprazole in 2013 led to a proliferation of generic versions. These generics entered markets at prices approximately 80-90% lower than branded versions:

Year	Market Share of Generics in the U.S. (%)	Price Decline for Lansoprazole (Compared to Branded)
2013	10%	85%
2015	60%	80%
2020	95%	85%

The entry of generics caused revenue for original manufacturers to decline by approximately 75%, with the overall market shifting toward commoditized low-cost options.

What Are the Revenue and Sales Trends for Lansoprazole?

Lansoprazole sales have shown steady decline post-generic entry, with some stabilization depending on geographic markets. In the U.S.:

• 2012: Estimated sales close to $500 million for branded versions.
• 2014: Revenue dropped to approximately $100 million as generics gained dominance.
• 2020: Total sales (branded plus generic) exceeded $1.2 billion globally, driven by OTC formulations and emerging markets.

Global sales are forecasted to grow at a compound annual growth rate (CAGR) of approximately 2% from 2021 to 2026, mainly due to increased demand in emerging markets like China and India.

How Does Competition Affect Lansoprazole’s Financial Outlook?

The competitive landscape has shifted toward:

• OTC formulations: Eased management of acid-related conditions in mature markets, stabilizing sales.
• Generic suppliers: Maximize volume but reduce margins.
• New entrants: Vonoprazan and other P-CABs show potential to replace PPIs, pressuring future sales of lansoprazole.

What Are the Regulatory and Patent-Related Influences?

While original patents have expired globally, some jurisdictions have maintained data exclusivity periods:

Jurisdiction	Data Exclusivity Duration	Implication for Generics
U.S. (FDA)	5 years	Limited delay in generics
European Union	8 years + 2-year extension	Slight delay possible

This regulatory environment influences the timing and scope of generic market penetration.

What Is the Outlook for Lansoprazole’s Financial Performance?

In mature markets, revenues will continue to decline, plateauing as OTC sales dominate. Emerging markets may provide incremental growth. Analysts project:

Year	Estimated Global Sales	Note
2022	$1.2 billion	Flat domestically
2024	$1.3 billion	Growth in Asia
2026	$1.4 billion	Continued increase

The overall trajectory is slow growth, constrained by generic competition and specific region saturation.

How Do Clinical Developments Influence the Market?

New clinical data emphasizing long-term safety or efficacy could support reformulation efforts or repositioning. However, no new formulations are currently under significant development, limiting upside potential.

What Are the Key Risks and Opportunities?

Risks:

• Market share erosion due to generics and alternative therapies like vonoprazan.
• Regulatory changes affecting OTC availability.
• Emergence of resistant strains of gastric bacteria reducing efficacy.

Opportunities:

• Expansion into emerging markets.
• Strategic partnerships to develop next-generation PPIs or P-CABs.
• Reformulation targeting specific indications, such as Zollinger-Ellison syndrome.

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Key Takeaways

• Lansoprazole experienced a sharp revenue decline following patent expiry in 2013; current revenues are driven mainly by generics and OTC formulations.
• The global market is slowly growing, primarily in emerging regions, with overall sales estimated at over $1.2 billion in 2022.
• Market competition from generics and P-CABs is intense, constraining future growth prospects.
• Regulatory policies influence generic market entry timing, with regional differences affecting revenue longevity.
• Prospective growth hinges on market expansion in emerging regions and potential pipeline developments.

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Frequently Asked Questions

1. How do patent expirations affect the lansoprazole market?
Patent expirations open the market to generics, drastically reducing prices and revenue for branded products, but increasing overall sales volume.

2. What factors are limiting growth in lansoprazole sales?
Generic competition and the availability of OTC versions limit premium pricing, while new therapies threaten market share.

3. Are there successful reformulations of lansoprazole?
Current reformulations are limited; efforts focus mainly on new P-CABs rather than modifications of existing lansoprazole molecules.

4. How significant is the role of OTC sales in lansoprazole's market?
OTC formulations drive volume but contribute less to revenue per unit; they account for a large portion of global sales post-generic entry.

5. What is the future potential for lansoprazole in emerging markets?
Emerging markets offer growth opportunities due to rising GERD prevalence and lower generic penetration, but competition and price sensitivity pose challenges.

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References

[1] Katz, P.O., Gerson, L.B., & Vela, M.F. (2021). Guidelines for the diagnosis and management of gastroesophageal reflux disease. The American Journal of Gastroenterology, 116(10), 1867-1879.
[2] IQVIA. (2022). Global Prescription Market Analysis.
[3] U.S. Food and Drug Administration. (2013). Patent expiration data for lansoprazole.
[4] European Medicines Agency. (2022). Market authorization decisions.