LANSOPRAZOLE Drug Patent Profile

Which patents cover Lansoprazole, and when can generic versions of Lansoprazole launch?

Lansoprazole is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms, 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, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, Zydus Pharms, and Rising. and is included in thirty-four NDAs. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Lansoprazole

Annual sales in 2022 were $103mm indicating the motivation for generic entry (peak sales were $689mm in 2010).

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 LANSOPRAZOLE

International Patents:	3
US Patents:	2
Applicants:	29
NDAs:	34
Finished Product Suppliers / Packagers:	61
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	198
Patent Applications:	5,820
Drug Prices:	Drug price information 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

LANSOPRAZOLE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	078730-001	Oct 15, 2010		DISCN	No	No
Sandoz	LANSOPRAZOLE	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	090331-002	Apr 23, 2010		DISCN	No	No
Mylan	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	202396-001	Nov 28, 2018	AB	RX	No	No
Dexcel	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208025-001	Jun 7, 2016		OTC	No	No			Y
Mylan	LANSOPRAZOLE	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	202396-002	Nov 28, 2018	AB	RX	No	No
Ani Pharms	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	200218-001	Aug 30, 2013		DISCN	No	No

International Patents for LANSOPRAZOLE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3288556
Israel	255048
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)

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

Last updated: July 28, 2026

Lansoprazole Market Dynamics and Financial Trajectory: Sales Trends, Patent/Exclusivity Timelines, and Generic/Biosimilar Risk

Lansoprazole is a mature oral proton pump inhibitor (PPI) with broad generic penetration in the US and international markets. Financial trajectory is dominated by price compression since patent expiries and ongoing substitution, with limited remaining brand leverage outside select formulations and geographies. Revenue growth, where it occurs, is driven by volume stability, payer contracting outcomes, and any lingering exclusivity around specific extended-release or delayed-release product variations rather than the core API.

How fast are lansoprazole sales declining after generic entry?

Core dynamic is sustained erosion of brand pricing and share after generic launches. US market structure is mostly generic-driven, with brand outcomes tied to payer preferences, coupon/contracting presence, and differentiated formulations rather than exclusivity.

What parts of the market still support non-zero brand revenue?

Brand performance is typically residual in:

• Original branded strength and package configurations that remain on some formularies.
• Markets where a limited number of manufacturers maintain contracted pricing or where fewer generics exist.
• Product line extensions tied to specific dosage forms (eg, delayed-release capsules vs. other oral formats), where substitution is slower.

What drives volume stability for lansoprazole versus category declines?

• Broad indication use for gastroesophageal reflux disease (GERD), erosive esophagitis, and ulcer-related indications.
• Long-duration prescribing patterns in chronic GERD cohorts.
• Generic PPIs compete primarily on net price and formulary status rather than differentiation.

Competitive set: how lansoprazole behaves relative to other PPIs

Lansoprazole competes in a crowded generic PPI pool that includes omeprazole, pantoprazole, esomeprazole, and others. Category pricing resets tend to be correlated across PPIs, so lansoprazole’s financial profile tracks:

• Generic discount intensity at the time of major launches for each molecule
• Payer-driven formulary switching
• Supply and manufacturing capacity constraints that occasionally shift near-term pricing

What patents protect lansoprazole and when do they expire?

Lansoprazole’s original compound and early formulations are long past initial exclusivity in major markets. Current patent relevance typically comes from:

• Specific formulation patents
• Process patents for manufacturing
• Method-of-use patents (less common for standard PPI indications at this stage)
• Secondary patents tied to dosage forms, stability, or specific release profiles

How many patent layers still matter in 2026?

For most commercial decisions today, practical IP value is limited to:

• Any remaining formulation-specific patents for particular marketed strengths or delivery systems
• Any process patents asserted or used to constrain generic manufacturing routes

For business planning, the operational assumption is that the core molecule is effectively off-exclusivity, so revenue trajectory depends more on generic pricing mechanics than on patent wall height.

Which jurisdictions historically show longer patent tails for lansoprazole?

Patent tail impact is usually most visible where:

• Secondary patents were filed and granted with longer effective life
• Litigation stayed generic entry temporarily (rare for fully mature products)
• Regulatory listing details in local reference markets delay substitution

What is the Orange Book status of lansoprazole and what listings matter to investors?

Lansoprazole products in the US are primarily supported by an Orange Book record set that reflects:

• Branded NDA listings (historical)
• Multiple ANDA generic listings for the same active ingredient and dosage form
• Potentially listed patents for formulation and method-of-use

What is the most decision-relevant Orange Book signal for lansoprazole right now?

• Whether any Orange Book-listed patents remain unexpired for specific dosage forms.
• Whether any ANDAs are tied to Paragraph IV certifications (an indicator of active patent dispute, though often absent for long-expired cores).

How Orange Book listings translate into commercial outcomes

Even with listed patents:

• For highly generic PPIs, payer substitution and physician switching drive rapid share transfer once no workable exclusivity remains.
• Litigation leverage is usually short-lived unless a settlement includes delayed launch terms.

When does lansoprazole lose exclusivity for specific formulations?

Exclusivity is mostly a formulation and packaging issue rather than active ingredient. The question is less “when does lansoprazole lose exclusivity” and more “when does a specific listed patent cover a specific marketed dosage form.”

What formulation variants change exclusivity timelines?

• Delayed-release capsule compositions
• Strength-specific reformulations
• Stability- or release-profile improvements
• Manufacturing process and polymorph or excipient selection (in jurisdictions where such matters are patentable and enforceable)

What generic entry risks exist for lansoprazole based on formulation patents?

Risk is generally:

• Low to moderate for core delayed-release capsules once multiple ANDAs exist.
• Higher for less common strengths, special packaging, or slightly different release approaches where fewer generic approvals exist.

How strong is the patent estate for lansoprazole versus generic penetration?

For a mature PPI, the patent estate is typically not the main determinant of revenue. The practical constraint on price and margin is the number of approved generics and the contracting intensity of payers.

Patent strength profile used in litigation and licensing

• Core API patents: largely irrelevant commercially.
• Secondary patents: may exist but are often limited to narrow product attributes.
• Process patents: can constrain certain manufacturing approaches but rarely stop competition if alternative compliant processes exist.

What matters for licensing deals in lansoprazole

Licensing activity, where it occurs, tends to focus on:

• Authorized generic arrangements
• Rights to specific formulation improvements
• Manufacturing know-how tied to reliability and cost reduction

What paragraph IV litigation affects lansoprazole launches?

Paragraph IV dynamics for lansoprazole are usually low visibility because:

• Multiple generic players already hold ANDA approvals.
• The brand’s remaining economic interest is reduced.
• Settlements, when present historically, often translate into earlier generic availability rather than long brand-led exclusivity.

Typical outcome pattern in mature PPIs

• Early generations of Paragraph IV suits create a wave of generic entries.
• Later suits are narrower, targeting specific strengths or formulations.
• Courts and settlements often determine launch timing but rarely reverse long-term price compression.

How does lansoprazole regulatory status affect market access and pricing?

Regulatory status affects availability through ANDA approvals and interchangeability/substitution frameworks.

What FDA pathway dynamics dominate for lansoprazole?

• ANDA pathway for generics: drives rapid market availability post-approval.
• Labeling equivalence: supports substitution under state pharmacy substitution rules.
• Bioequivalence standards: generally achievable for generic PPIs, reducing barriers.

What is the impact of labeling and dosing form on formulary uptake?

Payers prefer:

• Covered strengths that match standard dosing regimens
• Lower net cost generics
• Consistency in pill count and dosing instructions

How does lansoprazole compare financially with other PPIs like omeprazole and pantoprazole?

Financial trajectory is usually determined by net price and share retention after genericization, and these are similar across PPIs, with differences stemming from:

• Timing of early generic entry
• Number of generic competitors
• Contracting behavior and rebates
• Any remaining formulation differentiation

Relative positioning

In mature markets:

• Lansoprazole behaves like other generic PPIs: margin pressure is structural.
• Brand advantages are constrained to niche formularies or legacy prescribing.

Which companies compete in lansoprazole and how does that shape pricing?

Generic competition is concentrated among multiple ANDA holders. Price competition typically intensifies when:

• Several suppliers enter with similar acquisition costs
• Supply normalization removes constraints
• Payers run open contracting tenders

How many generic competitors typically matter to price?

Even where the API is broadly generic, the number of active contracting bids drives the real pricing floor. A handful of dominant suppliers can stabilize price levels, while additional entries push downward.

What sales and revenue drivers still influence lansoprazole in 2026?

The main levers are less “innovation” and more “commercial execution.”

Key revenue drivers

• Net price after payer rebates and PBM contracting
• Prescriber preference patterns in chronic GERD cohorts
• Pharmacy substitution rules and generic switching speed
• Competitive supply conditions in the generic base
• Channel mix (retail vs institutional) and formulary access

Key cost drivers

• API and excipient input costs
• Manufacturing capacity utilization
• Compliance costs (cGMP, stability, process validation)
• Litigation or regulatory defense costs (lower relative to early-stage products)

What generic entry risks exist for lansoprazole in key global markets?

Global risk is driven by:

• Regulatory approval timelines and dossier quality differences
• Local patent enforcement or regulatory exclusivity tails for specific formulations
• Presence of local champions and market entry strategies

Regional dynamic snapshots (business-level)

• US: mature generic market; incremental entries typically have limited incremental share impact unless they disrupt pricing.
• Europe: similar generic dominance; reimbursement and tendering govern net pricing.
• Emerging markets: timing can vary, but affordability pressure generally accelerates generic uptake once approvals clear.

Does lansoprazole have biosimilar-like dynamics?

No. Lansoprazole is a small-molecule chemical drug. The relevant framework is generic competition, not biosimilars.

What is the commercialization strategy for lansoprazole brands and generic holders?

• Brands: defend formulary position where contracts still support premium pricing, often focusing on specific strengths or pack sizes, then transition toward winding down.
• Generics: optimize for net cost, supply reliability, and contracting wins; expand across strengths and pack sizes to increase coverage and rebate attractiveness.

Key Takeaways

• Lansoprazole is fully in the generic-driven phase of the market; revenue is dominated by price compression rather than ongoing exclusivity.
• Current economic outcomes hinge on payer contracting, PBM/formulary behavior, and net pricing across retail and institutional channels.
• Patent value today is primarily formulation- and process-specific, with limited ability to change the overall competitive landscape.
• Generic entry is a recurring but largely incremental driver in a mature segment; supply and contracting intensity set the commercial floor.
• No biosimilar dynamics apply; competition is purely generic ANDA-based.

FAQs

1. Are there any still-protected lansoprazole formulations in the US that could delay generic substitution?
2. How do PBM formularies typically affect net pricing for generic PPIs like lansoprazole?
3. What excipient or release-profile differences are most likely to matter for lansoprazole generic product approval?
4. Does lansoprazole have meaningful differences in utilization between retail and hospital formularies?
5. What supply constraints most commonly impact generic PPIs’ pricing, including lansoprazole?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. ANDA Basics. FDA. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda
3. FDA. Drug Development and Drug Interactions: Bioequivalence. FDA. https://www.fda.gov/drugs/generic-drugs/generic-drugs-bioequivalence

DrugChatter Q&A for LANSOPRAZOLE

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