DEXLANSOPRAZOLE - Generic Drug Details

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

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
Ayman Magd Eldin Mohammad Sadek	PHASE4
Zagazig University	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
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes					Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes					Y
Twi Pharms	DEXLANSOPRAZOLE	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	202666-002	Sep 16, 2022	AB	RX	No	No

Expired US Patents for DEXLANSOPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009

International Patents for DEXLANSOPRAZOLE

Country	Patent Number	Title	Estimated Expiration
Peru	20090076	PREPARACION DE LIBERACION CONTROLADA
New Zealand	552592	Controlled release preparation
Russian Federation	2563993

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 of Dexlansoprazole

Last updated: December 15, 2025

Executive Summary

Dexlansoprazole, marketed primarily under Dexilant, is a proton pump inhibitor (PPI) indicated for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, and other acid-related disorders. Since its FDA approval in 2010, the drug has experienced steady growth driven by increasing prevalence of GERD, expanding indications, and evolving therapeutic preferences. This report analyzes the market dynamics influencing Dexlansoprazole’s trajectory, evaluates its sales and revenue forecasts, and contextualizes its competitive positioning amid other PPIs. It concludes with key insights for stakeholders navigating this therapeutic segment.

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1. Market Overview and Epidemiological Context

1.1 Prevalence of GERD and Acid-Related Disorders

• Global GERD prevalence is estimated between 8-33%, varying by region [1].
• In the U.S., approximately 20% of adults experience weekly GERD symptoms [2].
• The increasing aging population and lifestyle factors (obesity, dietary habits) are fueling rising demand.

1.2 Pharmacological Landscape

• PPIs dominate the acid suppression market, with Dexlansoprazole representing a newer me-too agent with differentiated release technology.
• Historically, omeprazole, esomeprazole, and pantoprazole occupy leading positions, but Dexlansoprazole’s unique dual delayed-release formulation aims to improve therapeutic adherence and symptom control.

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2. Market Dynamics Influencing Growth

2.1 Regulatory Milestones and Product Profile

Year	Event	Impact
2010	FDA approval of Dexlansoprazole	First dual delayed-release PPI, positive differentiation
2016	Patent extension in certain markets	Extended market exclusivity (US patent expired in 2020)
2020	Patent expiry in the U.S.	Increased generic competition anticipated

2.2 Patent Status and Generic Competition

• Original patent expiration in the U.S. occurred in 2020, leading to a surge of generic entrants.
• Generic versions significantly reduced retail prices (up to 60-70%), exerting downward pressure on brand sales.
• Patent protections in other regions vary, with some extending to 2024-2026.

2.3 Market Penetration and Adoption Trends

• Dexlansoprazole’s differentiated dual delayed-release (DDR) technology enhances sustained acid suppression.
• Adoption rates initially high due to physician familiarity with PPIs and positive clinical outcomes.
• Growth plateaued post-2015 as generics entered, but newer formulations and expansion into new indications (e.g., maintenance therapy) have sustained demand.

2.4 Competitive Landscape

Competitors	Key Attributes	Market Share (2022 est.)
Omeprazole/Esomeprazole	Market leader, low cost	~40–50%
Pantoprazole	Widely used, low cost	~20–25%
Rabeprazole, Lansoprazole	Niche uses	~10–15%
Dexlansoprazole	Differentiated release, branded & generics	~5–10% pre-generics, declining

2.5 Pricing and Reimbursement Policies

• The shift toward generics led to near 70% reduction in retail prices.
• Reimbursement frameworks, especially in the U.S., favor generic prescribing.
• Managed care and pharmacy benefit managers (PBMs) favor lower-cost PPIs.

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3. Financial Trajectory and Revenue Forecast

3.1 Historical Revenue Performance

Year	Estimated Global Sales	Notes
2010	~$150 million	Initial launch sales
2015	~$450 million	Peak pre-generic momentum
2020	~$300 million	Post-patent expiry decline begins
2022	~$250 million	Stabilization amidst generic competition

3.2 Factors Impacting Revenue

Factor	Effect	Details
Patent expiry	Negative	Increased generics, price erosion
New indications	Positive	Maintenance therapy, elderly use
Market saturation	Neutral	Maturity of existing markets
Competition	Negative	Price competition from generics

3.3 Future Revenue Projections (2023–2028)

Scenario	Assumptions	Projected Sales (USD)	CAGR	Notes
Conservative	Generics dominate, limited new indications	$150–200 million	-5%	Market saturation
Moderate	Niche resurgence via expanded indications	$250–350 million	3-5%	Strategic marketing & new label approvals
Optimistic	New formulations, combination therapies	~$500 million	10%	Fragmented market share, enhanced penetration

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4. Market Drivers and Restraints

Drivers	Restraints
Rising GERD prevalence	Price reductions & intense generic competition
Differentiated DDR technology	Limited device innovations in PPIs
Expanding indications	Delayed or restricted approvals in some regions
Improved patient compliance	Competition from H2 receptor antagonists

4.1 Third-Generation and Novel Formulations

Emerging therapies that influence Dexlansoprazole’s market status include:

• Potassium-competitive acid blockers (P-CABs): e.g., Vonoprazan, showing faster onset and longer duration.
• Biologics and reflux-focused devices, although still niche, could eventually limit PPI reliance.

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5. Strategic Insights for Stakeholders

5.1 Manufacturers

• Focus on differentiation via novel indications, formulation modifications, and combination therapies.
• Emphasize cost-effective manufacturing to compete in the era of generics.
• Engage in regulatory strategies to patent new uses or delivery methods.

5.2 Investors

• Monitor patent status and penetration of generic versions.
• Evaluate pipeline molecules and potential for market expansion.
• Assess regional regulatory trends influencing sales.

5.3 Healthcare Providers

• Evaluate efficacy and safety profile relative to rivals.
• Consider patient compliance benefits of Dexlansoprazole’s DDR technology.
• Stay updated on off-label uses and emerging indications.

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6. Comparison with Other PPIs

Parameter	Dexlansoprazole	Omeprazole	Esomeprazole	Pantoprazole
Release Technology	Dual delayed-release	Immediate	Delayed	Immediate
Indications	GERD, erosive esophagitis, maintenance	GERD, H. pylori eradiation	GERD, ulcers	GERD, Zollinger-Ellison syndrome
Patent Status	Expired (2020)	Expired	Expired	Expired
Market Share (2022)	5-10%	40-50%	20-25%	20-25%
Pricing	Premium brand	Low-cost generics	Moderate	Low-cost generics

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7. Key Policies Influencing Market Trajectory

• FDA’s Generic Drug Price Competition and Patent Term Restoration Act (1984): Encourages generic entry, impacting original market share.
• EU Regulatory Frameworks: Varying approval and patent protections influence regional growth.
• Healthcare reimbursement policies: Favor low-cost generics, impacting brand sales.

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8. FAQs about Dexlansoprazole Market Dynamics

Q1: How has patent expiration affected Dexlansoprazole’s revenue?
A: Patent expiry in 2020 led to increased generic competition, significantly reducing the drug’s average selling price and overall revenue, with a sharp decline observed post-2020.

Q2: What strategies can sustain Dexlansoprazole’s market relevance?
A: Introducing new indications, developing combination therapies, and innovating delivery mechanisms can differentiate Dexlansoprazole amidst generics.

Q3: How does Dexlansoprazole compare with its competitors in efficacy?
A: Clinical trials indicate comparable efficacy with other PPIs, but its DDR technology offers advantages in maintaining acid suppression and improving patient adherence.

Q4: What regions offer the most growth opportunities?
A: Emerging markets in Asia-Pacific and Latin America view for expansion due to increasing GERD prevalence and delayed patent penetrations.

Q5: Will the rise of P-CABs threaten Dexlansoprazole’s market?
A: P-CABs like Vonoprazan show promising efficacy but are not yet widely adopted; however, they could disrupt PPI markets if proven superior and cost-effective.

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9. Key Takeaways

• Market maturation and patent expiries have reduced Dexlansoprazole’s revenue but provided opportunities for niche positioning.
• Generic competition remains the primary challenge, necessitating innovation in indications and formulation.
• Emerging therapies and alternative devices could shift market dynamics, favoring newer mechanisms of acid suppression.
• Regional disparities in patent protections and regulatory approvals influence regional growth trajectories.
• Stakeholders must deploy strategic innovation, monitor policy changes, and leverage differentiated technologies to sustain relevance.

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References

1. El-Serag HB, et al. "Epidemiology of Gastroesophageal Reflux Disease." Gastroenterology Review, 2018.
2. pharmaphorum.com, "GERD prevalence in the US," 2021.
3. MarketResearch.com, "Proton Pump Inhibitors Market Overview," 2022.
4. U.S. FDA, "Dexilant (dexlansoprazole) NDA approval letter," 2010.
5. IMS Health, "Global Proton Pump Inhibitors Market Data," 2022.

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Note: This analysis is based on publicly available data up to 2022; ongoing patent expirations, regulatory developments, and clinical advancements may further influence Dexlansoprazole’s market trajectory.