DEXLANSOPRAZOLE - Generic Drug Details

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

Dexlansoprazole is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Alembic, Mylan, Ph Health, and Twi Pharms, and is included in six NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexlansoprazole has one hundred and fifty-one patent family members in thirty-eight countries.

There are seventeen drug master file entries for dexlansoprazole. Eleven suppliers are listed for this compound.

Summary for DEXLANSOPRAZOLE

International Patents:	151
US Patents:	10
Tradenames:	3
Applicants:	5
NDAs:	6
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	52
Patent Applications:	1,774
Drug Prices:	Drug price trends for DEXLANSOPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXLANSOPRAZOLE
What excipients (inactive ingredients) are in DEXLANSOPRAZOLE?	DEXLANSOPRAZOLE excipients list
DailyMed Link:	DEXLANSOPRAZOLE at DailyMed

See drug prices for DEXLANSOPRAZOLE

Recent Clinical Trials for DEXLANSOPRAZOLE

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

Sponsor	Phase
Zagazig University	PHASE4
Ayman Magd Eldin Mohammad Sadek	PHASE4
University of Karachi	Phase 1

See all DEXLANSOPRAZOLE clinical trials

Pharmacology for DEXLANSOPRAZOLE

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for DEXLANSOPRAZOLE

Anti-Ulcer Agents

Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DEXLANSOPRAZOLE

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 DEXLANSOPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEXILANT	Delayed-release Capsules	dexlansoprazole	30 mg	022287	1	2010-11-30

US Patents and Regulatory Information for DEXLANSOPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	DEXLANSOPRAZOLE	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	205205-002	Jan 19, 2024	AB	RX	No	No
Alembic	DEXLANSOPRAZOLE	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	219115-001	Nov 12, 2025	AB	RX	No	No
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	9,011,926		Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	9,233,103
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	8,461,187*PED				Y

Expired US Patents for DEXLANSOPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	6,664,276*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	7,285,668*PED
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	8,784,885*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	5,045,321*PED
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	7,875,292*PED

International Patents for DEXLANSOPRAZOLE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1202441
Tunisia	2010000411	ORALLY-DISINTEGRATING SOLID PREPARATION
European Patent Office	1852100	PROCÉDÉ DE FABRICATION DE GRANULÉS ENROBÉS DU BENZIMIDAZOLE (METHOD FOR PRODUCING COATED GRANULES OF A BENZIMIDAZOLE COMPOUND)
Russian Federation	2563993
European Patent Office	2275088	Procédé de fabrication de granulés (Method for producing granules)

Supplementary Protection Certificates for DEXLANSOPRAZOLE

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

Market Dynamics and Financial Trajectory for DEXLANSOPRAZOLE

Last updated: October 13, 2025

Introduction

Dexlansoprazole, a proton pump inhibitor (PPI), is marketed under the brand name Dexilant among others. It is primarily indicated for the treatment of erosive esophagitis, gastroesophageal reflux disease (GERD), and other acid-related disorders. Since its approval, Dexlansoprazole has positioned itself within a competitive landscape driven by evolving market dynamics, patent protections, and shifting healthcare policies. This article analyzes the current market factors influencing Dexlansoprazole's trajectory, providing a strategic outlook for stakeholders and investors.

Market Overview

The global proton pump inhibitor market is substantial, estimated to reach USD 27 billion by 2025, with a CAGR of approximately 4% (Research and Markets, 2022). Dexlansoprazole's unique pharmacokinetic profile—dual delayed-release formulation—yields extended acid suppression, differentiating it from traditional PPIs like omeprazole. This innovation records high patient adherence and satisfaction, contributing to its ongoing demand, especially within North America and Europe.

Market Drivers

1. Rising Prevalence of Acid-Related Disorders

The increased global burden of GERD and erosive esophagitis strongly fuels demand for effective PPIs. According to the World Gastroenterology Organisation, GERD prevalence exceeds 20% in Western countries, with increasing trends linked to obesity, dietary changes, and lifestyle factors.

2. Advancements in Drug Formulation

Dexlansoprazole's dual-release technology extends symptom relief and reduces dosing frequency — features that appeal to clinicians and patients alike. This formulation innovation positions Dexlansoprazole favorably against first-generation PPIs, which may require multiple daily doses.

3. Patent Protections and Market Exclusivity

Dexlansoprazole's patents, initially granted in 2009, provided market exclusivity until mid-2020 in key regions. This exclusivity afforded premium pricing and limited generic competition during the patent term. Recent patent expirations, however, mark a critical inflection point reducing revenue potential unless extended protection or new formulations are developed.

4. Shift Toward Personalized Medicine

The growing emphasis on personalized treatment strategies for acid-related disorders increases demand for drugs with proven safety and efficacy profiles, emphasizing Dexlansoprazole's extended duration benefits.

Market Challenges

1. Patent Expiry and Generic Competition

The patent expiration of Dexlansoprazole in key markets paved the way for generic entrants, pressuring average selling prices (ASPs). Generic versions typically undercut brand-name prices, leading to erosion of revenue streams. For example, in the US, generics account for over 90% of PPI prescriptions, significantly impacting branded sales (IQVIA, 2021).

2. Competition from Other PPIs and Novel Therapies

Competitors like omeprazole, esomeprazole, and newly developed drugs such as potassium-competitive acid blockers (e.g., vonoprazan) challenge Dexlansoprazole's market share. These alternatives often provide comparable efficacy at lower costs or improved safety profiles, influencing prescribing patterns.

3. Regulatory and Market Access Pressures

Increasing healthcare cost containment measures, such as formulary restrictiveness and reimbursement constraints, threaten profitability. Payers often favor lower-cost generics, compelling manufacturers to adopt aggressive pricing strategies.

4. Diagnostic and Treatment Guidelines Evolution

Updated clinical guidelines emphasizing step-down therapy and the use of test-and-treat strategies influence prescribing behaviors, potentially impacting demand for long-term PPI therapy, including Dexlansoprazole.

Financial Trajectory and Revenue Outlook

Post-patent expiration in 2020, Dexlansoprazole experienced notable revenue declines globally. However, strategic shifts—such as expanding into new indications like non-erosive reflux disease (NERD), Barrett's esophagus, or off-label uses—could offset market pressures.

Innovative formulations, biosimilars, or combination therapies are potential revenue stimulants. For example, development of combination drugs targeting multiple gastrointestinal pathways may offer premium positioning and differentiated market segments.

Analyst projections suggest that global Dexlansoprazole sales will decline at a CAGR of approximately 3-5% over the next five years, depending on regional patent statuses and competitive dynamics. In North America—the largest market—sales are expected to stabilize, driven by brand loyalty and specialty therapy adoption.

Regional Market Insights

North America

Largest market, accounting for nearly 50% of global PPI sales. Patent protections maintained higher pricing power until significant generics entered post-2020.

Europe

Moderate market size; reimbursement policies and stricter regulatory environments impact profit margins.

Asia-Pacific

Emerging market with increasing GERD prevalence; however, affordability and regulatory hurdles limit rapid uptake of branded Dexlansoprazole.

Strategic Opportunities

Innovations like extended-release formulations, development of novel PPI analogs, or combination regimens represent pathways to sustain revenue streams. Strategic licensing agreements or partnerships with generic manufacturers may also enhance market presence post-patent expiry.

Conclusion

Dexlansoprazole's journey exemplifies the typical lifecycle of branded pharmaceuticals, faced with market maturation, patent expirations, and competitive pressures. While the initial growth phase has plateaued, opportunities exist for incremental revenues through formulation innovation, strategic positioning, and expanding indications. Market players must adapt quickly to the evolving healthcare landscape—balancing cost-containment measures with differentiation strategies—to optimize financial outcomes.

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Key Takeaways

• The expiration of Dexlansoprazole patents in 2020 significantly shifted market dynamics, leading to increased generic competition and pricing pressures.
• Rising global prevalence of GERD and related disorders sustains demand, but cost-efficiency preferences favor generics and biosimilars.
• Innovation in drug delivery and potential new indications provides pathways for revenue stabilization.
• Strategic alliances and licensing in emerging markets can unlock new growth prospects.
• Continuous monitoring of regulatory, reimbursement, and clinical guideline shifts is crucial for informed market positioning.

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FAQs

1. How does patent expiration affect Dexlansoprazole’s market share?
Patent expiration allows generic manufacturers to produce cost-effective versions, drastically reducing brand-name sales and market share for Dexlansoprazole. The loss of patent protection often leads to revenue declines unless offset by new formulations or indications.

2. What are the main competitors to Dexlansoprazole in the PPI market?
Main competitors include other branded PPIs such as esomeprazole (Nexium), omeprazole (Prilosec), and newer drugs like vonoprazan, a potassium-competitive acid blocker. Generics for these drugs further intensify competition.

3. Can Dexlansoprazole’s unique formulation sustain its market position?
Yes, its dual delayed-release mechanism offers extended acid suppression, potentially favoring specific patient segments. However, its ability to sustain market share depends on pricing, reimbursement, and clinical guideline updates.

4. Are there emerging markets for Dexlansoprazole?
Asia-Pacific and Latin America show growth potential due to rising GERD prevalence. However, market entry depends on regulatory approval, pricing, and local healthcare infrastructure.

5. What strategies might prolong Dexlansoprazole’s revenue trajectory?
Approaches include developing new formulations, expanding approved indications, engaging in strategic licensing with generics, and exploring combination therapies that enhance efficacy or safety profiles.

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References

1. Research and Markets. (2022). Proton Pump Inhibitors Market – Growth, Trends, and Forecasts (2022–2027).
2. IQVIA. (2021). Global Trends in Prescription Medication Pricing and Market Share.
3. World Gastroenterology Organisation. (2020). GERD Epidemiology and Global Burden.