DEXILANT SOLUTAB Drug Patent Profile

When do Dexilant Solutab patents expire, and when can generic versions of Dexilant Solutab launch?

Dexilant Solutab is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are five patents protecting this drug.

This drug has fifty patent family members in twenty-seven countries.

The generic ingredient in DEXILANT SOLUTAB 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 Solutab

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

Summary for DEXILANT SOLUTAB

International Patents:	50
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	62
Patent Applications:	1,128
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXILANT SOLUTAB
DailyMed Link:	DEXILANT SOLUTAB at DailyMed

US Patents and Regulatory Information for DEXILANT SOLUTAB

DEXILANT SOLUTAB 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 SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	9,238,029		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 SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	9,011,926		Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	9,241,910		Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	8,871,273*PED				Y

Expired US Patents for DEXILANT SOLUTAB

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	7,399,485*PED
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	6,238,994*PED
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	9,145,389
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 SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	7,285,668*PED
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	7,431,942*PED

International Patents for DEXILANT SOLUTAB

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

Country	Patent Number	Title	Estimated Expiration
Poland	218177
China	1195500
South Africa	200108331	Benzimidazole compound crystal.
Malaysia	154010	RAPIDLY DISINTEGRABLE SOLID PREPARATION
Taiwan	I243062
South Korea	20120034809	CONTROLLED RELEASE PREPARATION

Supplementary Protection Certificates for DEXILANT SOLUTAB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2014014,C1129088	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	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
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	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

Market Dynamics and Financial Trajectory for DEXILANT SOLUTAB

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape for acid-reflux solutions has evolved significantly, with Dexilant Solutab (dexlansoprazole) occupying a critical niche. As a proton pump inhibitor (PPI), it addresses chronic gastroesophageal reflux disease (GERD) and related conditions, driving consistent demand amidst competitive and regulatory shifts. Understanding its market dynamics and financial trajectory is essential for stakeholders aiming to optimize investment strategies and anticipate future growth.

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Overview of Dexilant Solutab

Dexilant Solutab, a novel formulation of dexlansoprazole, distinguishes itself through its unique dual delayed-release mechanism, providing extended acid suppression with a simplified dosing regimen. Originally launched by Takeda Pharmaceuticals in 2015, it offers an alternative to traditional PPIs, targeting a spectrum of acid-related disorders. The Solutab formulation enhances patient adherence and tolerability, leveraging the convenience of an orally disintegrating tablet.

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Market Dynamics Influencing Dexilant Solutab

1. Growing Prevalence of GERD and Acid-Related Disorders

The increasing global prevalence of GERD and related disorders fuels demand for effective acid suppression therapies. According to the World Gastroenterology Organisation, GERD affects approximately 20-30% of the Western population, with rising incidence in Asia-Pacific regions driven by dietary and lifestyle shifts[1]. This trend sustains a broad patient base for PPIs, including Dexilant Solutab.

2. Competitive Landscape

Dexilant faces competition from established PPIs—such as omeprazole, pantoprazole, lansoprazole—and newer agents including vonoprazan, a potassium-competitive acid blocker (P-CAB). While generic PPIs dominate due to their low cost, branded formulations like Dexilant differentiate through their efficacy, tolerability, and formulation innovations, such as Solutab.

Market share operators have to navigate patent challenges; Dexilant's exclusivity in key regions influences its revenue potential. The dual-delayed release mechanism confers an efficacy advantage, allowing for once-daily dosing and potentially better patient outcomes, which can support premium pricing.

3. Regulation and Pricing Dynamics

Regulatory approvals and evolving reimbursement policies significantly impact Dexilant Solutab's financial trajectory. The drug's patent expiry in certain markets opens pathways for generics, pressuring pricing and profit margins. Conversely, favorable reimbursement policies and formulary placements bolster revenue streams.

4. Wholesale and Prescriber Preferences

Physician prescribing habits pivot on medication efficacy, side effect profiles, and convenience. Dexilant's dual-release technology offers a pharmacokinetic profile conducive to improved symptom control, fostering continued usage. Market penetration hinges on educational efforts and clinical guidelines endorsing its role in GERD management.

5. Pharmaceutical Innovation and Pipeline Development

Ongoing research into PPIs and novel acid suppressants influences market dynamics. Benzodiazepine campaigns, combination therapies, and new formulations could challenge or complement Dexilant Solutab’s position. For instance, the advent of P-CABs like tradaprazole introduces alternatives with potentially superior efficacy profiles.

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Financial Trajectory Analysis

1. Revenue Trends and Market Penetration

Since its launch, Dexilant's sales have experienced initial growth followed by stabilization. In the United States, where patent protections and marketing efforts are strongest, revenues peaked around 2017-2018, with subsequent declines in markets facing generic competition[2]. The dual-delayed release mechanism slightly elevates per-unit pricing compared to generic PPIs.

Global revenue streams are expanding, driven by emerging markets where GERD diagnosis rates increase and newer formulations gain acceptance. Takeda's strategic partnerships, including licensing agreements, facilitate broader distribution in Asia-Pacific and Europe.

2. Impact of Patent Cliff and Generic Competition

Patent expiration in mature markets exposes Dexilant to generic entries, typically leading to substantial revenue erosion. For example, in the U.S., generic versions of dexlansoprazole entered the market after patent expiry in 2019, causing revenue declines[3]. To mitigate this, Takeda has diversified its portfolio and invested in extending formulations and combination therapies to preserve market share.

3. R&D and Pipeline Investment

Investments in clinical trials for new indications, such as Barrett’s esophagus and erosive esophagitis, bolster Dexilant's long-term prospects. While R&D expenditures temporarily impact profit margins, successful expansion into adjunct indications offers additional revenue streams.

4. Impact of Pricing Strategies and Market Access

Pricing strategies vary across regions; in highly regulated markets like Europe and Japan, negotiations with health authorities influence final reimbursement rates. Maintaining favorable access and positioning Dexilant as a premium yet cost-effective therapy sustains revenue margins during patent cliffs.

5. Future Revenue Outlook

Analysts project a gradual recovery in sales driven by the drug's differentiation and potential combination applications. However, growth prospects are tempered by generic competition, necessitating innovation and diversification strategies.

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Strategic Market Opportunities and Challenges

Opportunities

• Emerging Market Expansion: Increasing GERD prevalence in Asia and Latin America provides avenues for growth, especially with local manufacturing and strategic partnerships.

• Formulation Innovation: Enhanced delivery mechanisms, such as soluble or dissolvable formulations, could attract patient segments seeking convenience.

• Therapeutic Portfolio Diversification: Leveraging Dexilant’s mechanism for new indications like Zollinger-Ellison syndrome can extend revenue sources.

Challenges

• Generic Competition: Patent expiries threaten exclusivity and pricing power. Developing proprietary formulations or obtaining new patents is crucial.

• Market Saturation: In mature regions, growth potential diminishes unless new indications or formulations are introduced.

• Regulatory and Pricing Pressures: Increasing scrutiny on drug pricing and reimbursement strategies may compress profit margins.

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Conclusion

Dexilant Solutab’s market dynamics are shaped by a complex interplay of clinical advantages, competitive pressures, and regulatory policies. Its unique dual-delayed release technology supports sustained efficacy, underpinning its financial performance amidst generic challenging. While patent expiries and market saturation present hurdles, expanding into emerging markets, focusing on pipeline innovation, and optimizing pricing strategies can sustain its financial trajectory. Stakeholders must closely monitor market signals and evolving therapeutic landscapes to effectively capitalize on growth opportunities.

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Key Takeaways

• Market Growth Drivers: Rising GERD prevalence globally sustains demand for effective PPIs like Dexilant Solutab.

• Competitive Edge: Its innovative dual-delayed release mechanism offers differential benefits over traditional PPIs, supporting premium pricing temporarily.

• Patent and Generic Risks: Patent expirations in key markets could lead to revenue decline unless mitigated through formulation patents or indication expansions.

• Emerging Markets: Accelerating adoption in Asia-Pacific and Latin America presents significant growth opportunities.

• Strategic Focus: Investment in pipeline developments, formulation enhancements, and market access strategies are crucial to maintaining financial resilience.

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FAQs

1. How does Dexilant Solutab’s dual-delayed release technology impact its market position?
It offers prolonged acid suppression, improved symptom control, and enhanced patient compliance, differentiating it from traditional PPIs and justifying premium pricing in respective markets.

2. What are the primary factors influencing Dexilant’s revenue decline post-patent expiration?
The entry of generic dexlansoprazole competitors reduces market share, pressure on pricing, and shifts prescribing patterns away from branded formulations.

3. In which regions does Dexilant Solutab have the highest growth potential?
Emerging markets like China, India, and Latin America show promising growth due to rising GERD incidence and shifting healthcare infrastructure.

4. How do regulatory policies influence the financial prospects of Dexilant?
Stringent reimbursement controls and drug approval pathways directly impact market access, pricing, and ultimately, revenue generation.

5. What strategic moves can Takeda pursue to sustain Dexilant’s market share?
Expanding licensing in emerging markets, developing new formulations or indications, and securing additional patents are key strategies.

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References

[1] World Gastroenterology Organisation. "Global Prevalence of GERD." (2022).
[2] Takeda Pharmaceuticals. "Dexilant Sales Data & Market Reports." (2015-2022).
[3] U.S. FDA. "Patent and Generic Entry Data for Dexilant." (2020).