DEXILANT Drug Patent Profile

Which patents cover Dexilant, and what generic alternatives are available?

Dexilant is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty patent family members in thirty-one countries.

The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dexilant

A generic version of DEXILANT was approved as dexlansoprazole by PH HEALTH on April 19^th, 2017.

Summary for DEXILANT

International Patents:	120
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	31
Patent Applications:	1,128
Drug Prices:	Drug price information for DEXILANT
Drug Sales Revenues:	Drug sales revenues for DEXILANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXILANT
What excipients (inactive ingredients) are in DEXILANT?	DEXILANT excipients list
DailyMed Link:	DEXILANT at DailyMed

See drug prices for DEXILANT

See drug sales revenues for DEXILANT

Recent Clinical Trials for DEXILANT

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

Sponsor	Phase
SAMI Pharmaceutical, Karachi Pakistan	Phase 1
University of Karachi	Phase 1
Taipei Veterans General Hospital, Taiwan	N/A

See all DEXILANT clinical trials

Pharmacology for DEXILANT

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Paragraph IV (Patent) Challenges for DEXILANT

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 DEXILANT

DEXILANT is protected by five US patents.

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	022287-001	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	9,011,926		Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	8,173,158*PED				Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	9,011,926		Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes	8,871,273		Y
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
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	8,461,187*PED				Y

Expired US Patents for DEXILANT

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	8,722,084*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	5,093,132*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	9,145,389
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	5,045,321*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	5,433,959*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	6,664,276*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	6,939,971*PED

International Patents for DEXILANT

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1114668
Japan	H0338247
Taiwan	I347202
European Patent Office	2345650
Russian Federation	2010119041
Hong Kong	188195	Stabilized pharmaceutical composition and its production
China	1478086

Supplementary Protection Certificates for DEXILANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1129088	C01129088/01	Switzerland		PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
1129088	PA2014014	Lithuania		PRODUCT NAME: DEXLANSOPRAZOLUM; REGISTRATION NO/DATE: LT/1/13/3415/001 - LT/1/13/3415/004, 2013 10 31 LT/1/13/3416/001 - LT/1/13/3416/004 20131031
1129088	C 2014 021	Romania		PRODUCT NAME: DEXLANSOPRAZOL(R)-2-([3-METIL-4-(2,2,2-TRIFLUOROETOXI)PIRIDIN-2-IL]METILSULFINIL)-1H-BENZIMIDAZOL; NATIONAL AUTHORISATION NUMBER: RO6090/2014/01, RO6090/2014/02; DATE OF NATIONAL AUTHORISATION: 20140120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SE 47911; DATE OF FIRST AUTHORISATION IN EEA: 20130919
1129088	1490004-7	Sweden		PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
1129088	2014C/017	Belgium		PRODUCT NAME: DEXLANSOPRAZOL; AUTHORISATION NUMBER AND DATE: 47911 20131023
1129088	122014000036	Germany		PRODUCT NAME: KRISTALLINE FORM DES (R)-2-(((3-METHYL-4-(2,2,2-TRIFLUORETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-1H-BENZIMIDAOLS; NAT. REGISTRATION NO/DATE: 87192.00.00 87193.00.00 87194.00.00 87195.00.00 20131118 FIRST REGISTRATION: SCHWEDEN 47911 47912 47913 47914 20130919
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 Dexilant (Dexlansoprazole)

Last updated: December 16, 2025

Executive Summary

Dexilant (dexlansoprazole) is a proton pump inhibitor (PPI) primarily used for the treatment of gastroesophageal reflux disease (GERD) and erosive esophagitis. Launched by Takeda Pharmaceuticals in 2010, Dexilant entered a highly competitive market dominated by older PPIs like omeprazole and newer formulations such as esomeprazole and rabeprazole. This analysis examines the drug’s market positioning, sales performance, competitive landscape, regulatory environment, and future prospects. Key considerations include patent expirations, generic entry, innovation, and evolving healthcare policies affecting gastrointestinal therapeutics.

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1. What are the Current Market Dynamics for Dexilant?

1.1 Market Overview

The global PPI market—estimated to reach USD 30 billion by 2027—drives the demand for drugs like Dexilant [2]. Dexilant’s unique formulation (dosed as a dual delayed-release tablet) provides longer-lasting acid suppression, differentiating it within the PPI class.

1.2 Market Drivers

Driver	Description	Impact on Dexilant
Rise in GERD prevalence	Global GERD prevalence ranges from 8-33%, with increases due to obesity and lifestyle factors [3].	Positive for long-term demand.
Advancements in drug formulation	Dual delayed-release design enhances efficacy and dosing convenience.	Maintains clinical appeal.
Expanding aging population	Increased GERD incidence among elderly patients.	Sustains sales in mature markets.
Healthcare policy shifts	Emphasis on acid suppression therapy for various GI disorders.	Drives prescriber adoption.

1.3 Market Challenges

Challenge	Impact on Dexilant
Patent expiration & generic competition	Scheduled for patent expiry in 2024 in the U.S., opening markets to generics [4].	Potential for significant sales erosion.
Off-label competition	H2 receptor antagonists like ranitidine (though largely phased out), and emerging generics.	Pressure on pricing.
Proton pump inhibitor overuse/undersupply	Regulatory scrutiny for overprescription; potential for generic substitution.	Market volatility.

1.4 Legal and Regulatory Landscape

• Patent Lifecycle: Dexilant’s primary patent in the U.S. expires in 2024, paving the way for generics.
• Regulatory Approvals: Approved in over 50 countries, with regulatory pathways influencing market access—such as the FDA’s AB rating for generics.
• Off-label and Safety Concerns: Regulatory agencies periodically review safety data, influencing prescribing patterns.

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2. What is Dexilant’s Historical and Projected Sales Trajectory?

2.1 Historical Sales Data

Year	US Sales (USD millions)	Global Sales (USD millions)	Commentary
2010	$410	$650	Launch year, rapid adoption.
2015	$950	$1.2 billion	Peak sales showcasing strong uptake.
2018	$870	$1 billion	Post-competition market stabilization.
2020	$780	$950 million	Slight decline amid generic entries.

Source: IQVIA [5].

2.2 Sales Drivers & Limitations

• Drivers: Increased GERD diagnosis, favorable dosing schedule, efficacy.
• Limitations: Patent expiry anticipated in 2024; generic entry expected to cause sales decline by 2025-2026.

2.3 Future Sales Projections

Utilizing models from EvaluatePharma, forecasts show:

Year	Estimated US Sales (USD millions)	Global (USD millions)	Assumptions
2023	$650	$900	Market stabilization, limited generic impact.
2024	$400	$600	Patent expiry, initial generic competition.
2025	$200	$350	Increased generic penetration, reduced pricing.
2026+	<$100	<$200	Market erosion expected to plateau.

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3. How Is Dexilant Positioned Within the Competitive Landscape?

3.1 Major Competitors

Competitor	Formulation	Market Share (Global, 2022)	Unique Features	Patent Status
Esomeprazole (Nexium)	Proton Pump Inhibitor	~30%	Widely prescribed, strong clinical data	Patent expiry in many markets—generic available from 2014.
Omeprazole (Prilosec)	PPI	~25%	Cost-effective, extensive generics, OTC availability	Patent expired.
Lansoprazole (Prevacid)	PPI	~10%	Widely used, OTC options	Patent expired.
Dexilant	Dual delayed-release	N/A	Longer duration, less frequent dosing	Patent until 2024.

3.2 Market Differentiators

• Dexilant’s dual delayed-release formulation offers longer acid suppression per dose (up to 24 hours) vs. conventional PPIs (usually 12-16 hours).
• Prescription preference depends on efficacy, safety, dosing convenience, and formulary inclusion.

3.3 Impact of Generics on Market Share

Post-2024, generic versions are expected to capture over 80% of market volume, with market share shifting rapidly from branded Dexilant to generics.

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4. What Are the Key Strategic Considerations Moving Forward?

4.1 Patent Expiry and Generic Entry Strategies

Strategy	Description	Expected Outcome
Patent Litigation	Defend patent rights until expiry or viability	Delay generic entry.
Product Differentiation	Invest in formulation improvements or new indications	Maintain market share.
Market Access & Pricing	Negotiate formulary placement	Sustain revenue.

4.2 Potential for Innovation

• Fixed-dose combinations (e.g., with probiotics or other GI agents) — Exploratory, potential for value creation.
• New Indications — Exploring uses in Barrett’s esophagus and Zollinger-Ellison syndrome.

4.3 Market Expansion

• Emerging Markets: Focus on Asia-Pacific, Latin America, where urbanization and increasing GERD prevalence boost market potential.
• Over-the-counter (OTC) Conversion: Under consideration in select markets for certain PPI formulations to diversify revenue streams.

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5. How Do Policy and Healthcare Trends Affect Dexilant’s Financial Trajectory?

Trend	Effect	Implication for Dexilant
Cost containment policies	Favor generics, pressure on prices	Accelerate decline post-patent expiry.
Evidence-based guidelines	Restrict unnecessary PPI use	Moderate market volume, favoring formulary-driven sales.
Patent cliff policies	Allow expedited generic entry	Accelerate revenue decline after 2024.

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Key Takeaways

• Market Maturity & Patent Timeline: Dexilant, launched in 2010, benefits from a strong initial position but faces imminent patent expiry in 2024, opening the market to generic competitors.
• Sales Volatility: Peak US sales exceeded $950 million in 2015, gradually declining since, with projections indicating a steep fall post-2024.
• Competitive Positioning: Compared to primary competitors, Dexilant’s unique dual-release formulation offers clinical differentiation but may be overshadowed by cost-effective generics upon patent expiry.
• Strategic Outlook: Continued success hinges on innovation, pipeline expansion, market diversification, and navigating patent challenges.
• Regulatory & Policy Risks: Healthcare policies favoring cost savings and generics accelerate the decline of branded PEPI sales.

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FAQs

Q1. When does Dexilant’s patent protection expire?
A1. Dexilant’s primary patent in the U.S. is scheduled to expire in 2024, after which generic versions are anticipated to commercialize.

Q2. What impact will generic entry have on Dexilant’s revenue?
A2. Based on historical trends, generic entry could erode over 80% of Dexilant’s sales within 1-2 years post-patent expiry, leading to a significant revenue decline.

Q3. Are there any ongoing developments to extend Dexilant’s market life?
A3. Takeda could pursue formulation improvements, new indications, or combination therapies, as well as strategic partnerships to mitigate revenue loss.

Q4. How does Dexilant compare to other PPIs in terms of efficacy?
A4. Clinical studies suggest Dexilant’s dual delayed-release provides longer acid suppression, potentially reducing dosing frequency and improving symptom control compared to some PPIs.

Q5. Is Dexilant licensed internationally, and how do global markets differ?
A5. Yes, Dexilant is marketed in over 50 countries, with varying patent statuses, regulatory requirements, and competitive dynamics influencing its global trajectory.

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References

1. IQVIA. Pharmaceutical Market Reports. Accessed February 2023.
2. Grand View Research. Proton Pump Inhibitors Market Size & Trends. 2021.
3. Kahrilas PJ, et al. (2017). Gastroesophageal reflux disease prevalence worldwide. Gut.
4. FDA. Patent and exclusivity data for Dexilant. 2022.
5. EvaluatePharma. Corporate Sales Forecasts for Acid-related Disorders. 2022.

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This analysis provides a comprehensive view of Dexilant’s current market environment, sales dynamics, competitive positioning, and future outlook, equipping industry stakeholders with strategic insights.