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
University of Karachi	Phase 1
SAMI Pharmaceutical, Karachi Pakistan	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

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	7,285,668*PED
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	022287-001	Jan 30, 2009	8,722,084*PED

International Patents for DEXILANT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1768668	FORME POSOLOGIQUE A DOSES PPI MULTIPLES (MULTIPLE PPI DOSAGE FORM)
Hong Kong	188195	Stabilized pharmaceutical composition and its production
South Korea	100514204

Supplementary Protection Certificates for DEXILANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2014C/017	Belgium		PRODUCT NAME: DEXLANSOPRAZOL; AUTHORISATION NUMBER AND DATE: 47911 20131023
1129088	1490004-7	Sweden		PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919

Market Dynamics and Financial Trajectory for DEXILANT

Last updated: November 18, 2025

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Introduction

Dexilant (dexlansoprazole) stands as a prominent proton pump inhibitor (PPI), primarily prescribed to manage gastroesophageal reflux disease (GERD) and other related acid-related disorders. Launched by Takeda Pharmaceuticals in 2010, Dexilant sought to differentiate itself through an innovative dual delayed-release formulation, granting sustained acid suppression. This analysis explores its evolving market landscape, competitive positioning, revenue trajectory, regulatory factors, and future prospects to elucidate its financial outlook.

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Market Overview and Key Drivers

Global Gastroesophageal Reflux Disease (GERD) Burden

The global GERD market has experienced consistent growth, driven by rising obesity rates, aging populations, and increased healthcare awareness. According to a 2022 report by Grand View Research, the global GERD market is projected to reach USD 14.2 billion by 2028, with a compounded annual growth rate (CAGR) of approximately 4.2% from 2022 to 2028[1].

Prescription Trends and Physician Preferences

PPIs, including Dexilant, are first-line therapies for acid suppression. The therapy landscape has shifted with the advent of generic PPIs, offering cost-effective alternatives. However, Dexilant's unique dual delayed-release formulation provides a competitive edge for patients needing sustained relief, especially those with complex reflux issues.

Market Segments

The primary revenue segments for Dexilant include:

• Prescription Acids Suppression Therapy
• Chronic GERD Management
• Off-label Uses (e.g., Zollinger-Ellison syndrome)

Growth is also driven by expanding indications, especially for 'difficult-to-treat' cases requiring optimized acid control.

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Competitive Landscape and Market Share Dynamics

Patent Status and Generics

Dexilant’s patent protection expired in 2018, opening the market to generic formulations of dexlansoprazole. The entry of generics significantly subdued sales of the branded drug in established markets like the United States and Europe, as observed in pharmaceutical sales data (IQVIA, 2022).

Key Competitors

• Esomeprazole (Nexium)
• Omeprazole (Prilosec)
• Lansoprazole (Prevacid)
• Rabeprazole (Aciphex)

While these alternatives dominate due to their lower costs, Dexilant maintains a niche among patients requiring once-daily dosing with extended acid suppression, offering a differentiated profile that can command premium pricing in specific segments.

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Revenue and Financial Trajectory

Historical Revenue Performance

Initially, Dexilant achieved peak sales of approximately USD 1.1 billion in 2014. Post-generic entry, revenues declined sharply; for example, in 2021, revenues hovered around USD 250 million, reflecting market erosion but retaining a stable patient base in niche markets.

Post-Patent Strategies

Takeda engaged in strategic initiatives such as:

• Line Extensions and Combination Therapies: Investigating fixed-dose combinations, especially with medications addressing complex gastrointestinal conditions.
• Expanding Indications: Pursuing approval for additional uses, including treatment of Zollinger-Ellison syndrome.
• Market Expansion: Focus on emerging markets where generic penetration is slower and branded drugs still command significant market share.

Recent Trends and Future Outlook

The recent trajectory indicates a gradual stabilization rather than resurgence in branded Dexilant sales, primarily driven by brand loyalty among longstanding patients and physician prescribing patterns prioritizing proven, premium formulations.

In the context of patent expiry, revenue forecasts project continued decline unless new formulations or indications are successfully introduced. For instance, Takeda is exploring depositions and regulatory pathways for novel formulations, which could temper revenue erosion and open new growth avenues.

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Regulatory and Patent Considerations

Patent expirations have profoundly impacted DEXILANT’s market share. However, Takeda's strategic pursuit of new formulations and label expansions could offset generic competition. Furthermore, regulatory hurdles, including stringent approval processes for new indications, pose challenges but also opportunities if successfully navigated. Market exclusivity periods granted for novel formulations could provide temporary revenue buffers.

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Market Risks and Opportunities

Risks

• Generic Competition: The proliferation of bioequivalent formulations exerts pricing pressure.
• Market Saturation: Established markets are saturated, limiting growth.
• Prescriber Preference Shifts: Increasing adoption of over-the-counter (OTC) PPIs diminishes prescription volumes.
• Emerging Competitors: Newer therapeutic options for GERD, such as potassium-competitive acid blockers (P-CABs), threaten PPI dominance.

Opportunities

• Extended Indications: Expanding approvals for additional gastric conditions can generate incremental revenue.
• Geographical Expansion: Emerging markets—Asia-Pacific, Latin America—offer growth potential due to lower generic penetration.
• Formulation Innovation: Once-daily dual delayed-release formulations could carve out niche markets among refractory GERD cases.
• Combination therapies: Integration with probiotics or other gastroprotective agents.

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Conclusion and Future Prospects

Dexilant faces a challenging but not insurmountable market landscape. While patent expiry and generic competition have impaired peak sales, strategic initiatives, including indication expansion and regional growth, can stabilize or enhance its financial trajectory. The continued innovation in formulation technology and potential approval for new indications are pivotal.

The drug's future earnings hinge on Takeda's ability to differentiate its offerings and penetrate emerging markets, supplemented by cost-effective alternatives in mature regions. Long-term profitability will depend on balancing market saturation, competitive threats, and ongoing pipeline development.

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Key Takeaways

• Market contraction post-patent expiry has significantly impacted Dexilant revenues, but niche positioning preserves its relevance.
• Generic competition dominates in mature markets, necessitating differentiation via formulations, indications, or regional expansion.
• Emerging markets and new formulations are potential growth avenues, especially where pharmacoeconomic constraints favor branded medications.
• Pipeline development for novel indications and delivery systems offers risk mitigation and future revenue streams.
• Strategic partnerships and cost management are critical for maintaining profitability amid competitive pressures.

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FAQs

1. How has patent expiry affected Dexilant’s market share?
Patent expiry in 2018 led to widespread generic entry, causing a sharp decline in branded sales and market share erosion. Nonetheless, Dexilant retains a therapeutic niche among patients requiring extended acid suppression.

2. Are there new formulations of Dexilant in development?
Takeda is exploring new formulations and indications, including potential once-daily dual delayed-release formulations aimed at refractory GERD patients, which could extend market exclusivity.

3. Which regions present the most significant growth opportunities for Dexilant?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa offer growth potential due to delayed generic penetration and unmet needs for branded therapies.

4. How does Dexilant differentiate from other PPIs?
Its dual delayed-release technology provides prolonged acid suppression, offering advantages for patients with difficult-to-control reflux, distinguishing it from standard PPIs.

5. What are the primary challenges facing Dexilant’s future sales?
Key challenges include aggressive generic pricing, OTC shift of PPIs, competition from new acid-suppressive agents like P-CABs, and regulatory hurdles for new indications.

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References

[1] Grand View Research, "Gastroesophageal Reflux Disease (GERD) Market Size & Share Analysis," 2022.