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. Nine 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 ENDO OPERATIONS 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:	61
Clinical Trials:	31
Patent Applications:	775
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
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No			Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No					Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No			Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes			Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No					Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No					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
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	022287-001	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	022287-001	Jan 30, 2009
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009

International Patents for DEXILANT

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1129088
Hong Kong	1202441	與食物攝入無關的治療胃腸病症的方法 (METHODS OF TREATING GASTROINTESTINAL DISORDERS INDEPENDENT OF THE INTAKE OF FOOD)
Norway	326019
Canada	1327010	COMPOSITIONS PHARMACEUTIQUES CONTENANT UN COMPOSE ANTI-ULCEREUX DE TYPE BENZIMIDAZOLE ET SA PRODUCTION (STABILIZED SOLID PHARMACEUTICAL COMPOSITION CONTAINING ANTIULCER BENZIMIDAZOLE COMPOUND AND ITS PRODUCTION)
South Africa	200108331	Benzimidazole compound crystal.
Norway	342002
Japan	5756548

Supplementary Protection Certificates for DEXILANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	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	C01129088/01	Switzerland		PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
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

Last updated: July 3, 2025

Introduction

In the competitive landscape of pharmaceutical drugs, DEXILANT stands out as a key player in treating gastroesophageal reflux disease (GERD) and related acid-related conditions. Developed by Takeda Pharmaceuticals, this proton pump inhibitor (PPI) has generated significant revenue while navigating evolving market pressures. As business professionals assess investment opportunities, understanding DEXILANT's market dynamics and financial path provides critical insights into its sustainability and growth potential.

Overview of DEXILANT

DEXILANT, known generically as dexlansoprazole, entered the market in 2009 after receiving FDA approval for managing heartburn and erosive esophagitis. It works by suppressing acid production in the stomach, offering dual-release technology that extends its efficacy compared to earlier PPIs. Takeda markets it primarily in the U.S. and select international regions, positioning it as a premium option for patients requiring long-term GERD management.

The drug's appeal lies in its ability to address unmet needs, such as maintaining pH levels for up to 24 hours, which enhances patient compliance. With global GERD prevalence rising—driven by factors like obesity and aging populations—DEXILANT has captured a niche in a market valued at over $15 billion annually. However, its trajectory hinges on patent protections and competitive forces that could erode its market share.

Market Dynamics

Competitive Landscape

DEXILANT faces intense competition from established PPIs like AstraZeneca's Nexium and Pfizer's Prilosec, which dominate the GERD space with lower-cost generics. In the U.S., generics account for nearly 80% of PPI prescriptions, pressuring DEXILANT's branded pricing. Takeda's strategy involves emphasizing DEXILANT's superior pharmacokinetics, such as its delayed-release formulation, to justify its premium. Yet, entrants like generic versions from Teva Pharmaceuticals have chipped away at its 10-15% market share in the PPI segment.

Regulatory hurdles further complicate dynamics. The FDA's ongoing scrutiny of PPIs for potential side effects, such as increased risk of kidney issues, has led to label updates for DEXILANT in 2022. This regulatory environment demands robust post-market surveillance from Takeda, potentially increasing operational costs. Internationally, variations in reimbursement policies—such as stricter controls in Europe—limit DEXILANT's expansion, with sales outside the U.S. comprising less than 20% of total revenue.

Market Trends and Growth Drivers

The GERD market is expanding at a compound annual growth rate (CAGR) of 4-5% through 2028, fueled by rising healthcare spending and an aging demographic. DEXILANT benefits from this trend, particularly in North America, where demand for advanced therapies grows. However, the rise of alternative treatments, like H2 blockers and emerging biologics for refractory GERD, poses a threat. Takeda's response includes partnerships for combination therapies, such as integrating DEXILANT with anti-inflammatory agents, to differentiate it.

Patent expirations represent a pivotal dynamic. DEXILANT's core patents began expiring in 2023, opening the door to biosimilars and eroding exclusivity. This shift could reduce Takeda's pricing power, with generic penetration potentially reaching 50% by 2025. On the upside, emerging markets in Asia-Pacific offer growth opportunities, where increasing GERD awareness and healthcare infrastructure could boost DEXILANT's adoption.

Financial Trajectory

Sales History and Revenue Performance

DEXILANT has been a reliable revenue generator for Takeda, with U.S. sales peaking at approximately $1.2 billion in 2021 before a slight decline to $1.0 billion in 2023 amid generic competition. This trajectory reflects broader pharmaceutical trends, where branded drugs experience a post-patent slump. Takeda's global pharmaceutical division reported DEXILANT contributing 5-7% to its overall revenue, underscoring its strategic importance despite fluctuations.

Financially, DEXILANT's performance correlates with market access strategies. In 2022, Takeda secured favorable formulary placements in major U.S. insurers, boosting prescription volumes by 8%. However, net sales dropped 15% year-over-year in 2023 due to patent losses, highlighting vulnerability. Gross margins for DEXILANT remain strong at 70-75%, driven by efficient manufacturing, but operating expenses—particularly in marketing to counter generics—have risen.

Revenue Projections and Key Metrics

Looking ahead, analysts project DEXILANT's revenue to stabilize at $800-900 million annually through 2027, assuming Takeda adapts through cost controls and market expansions. Key metrics like return on investment (ROI) for DEXILANT-related R&D stand at 12-15%, based on its sustained cash flow. However, EBITDA margins could contract to 25-30% if generic erosion accelerates, as forecasted by industry reports.

Takeda's financial strategy involves diversification, with DEXILANT funding pipeline investments in oncology and rare diseases. For instance, reallocating 10% of DEXILANT profits to new drug development could mitigate risks. External factors, such as inflation and supply chain disruptions, add uncertainty; a 2023 supply shortage temporarily reduced sales by 5%, emphasizing the need for resilient operations.

Challenges and Opportunities

DEXILANT's path forward is marked by challenges like intensifying competition and regulatory shifts. The entry of low-cost generics from players like Mylan threatens to halve DEXILANT's market share by 2026, while global economic downturns could dampen consumer spending on non-essential drugs. Additionally, evolving payer negotiations—such as value-based pricing models—may force price reductions, impacting profitability.

Yet, opportunities abound. Takeda is exploring label expansions for DEXILANT in pediatric GERD and maintenance therapy, potentially adding $200-300 million in annual revenue. Strategic alliances, like recent collaborations with digital health firms for remote monitoring, could enhance patient adherence and create new revenue streams. In emerging markets, where GERD incidence is climbing, targeted launches could yield double-digit growth, positioning DEXILANT for long-term resilience.

Conclusion

DEXILANT's market dynamics and financial trajectory illustrate the delicate balance in pharmaceuticals between innovation, competition, and profitability. As Takeda navigates patent cliffs and market shifts, its ability to adapt will determine sustained success in a maturing GERD sector.

Key Takeaways

• DEXILANT maintains a strong position in the PPI market despite generic threats, with U.S. sales stabilizing around $1 billion annually.
• Patent expirations and regulatory pressures could reduce revenue by 15-20% in the near term, but expansion into new indications offers growth potential.
• Takeda's focus on premium positioning and international markets is key to offsetting competitive challenges.
• Financial metrics like high gross margins (70-75%) underscore DEXILANT's profitability, though EBITDA may face pressure from rising costs.
• Business professionals should monitor GERD market trends, as they directly influence DEXILANT's investment viability.

FAQs

1. What factors are driving DEXILANT's market competition? Generic entrants and established PPIs like Nexium are primary competitors, eroding DEXILANT's share through lower pricing and similar efficacy.

2. How has DEXILANT's revenue changed in recent years? Revenue peaked at $1.2 billion in 2021 but fell to $1.0 billion in 2023 due to patent expirations and increased generic availability.

3. What regulatory challenges does DEXILANT face? FDA label updates for potential side effects and varying international reimbursement policies pose ongoing hurdles for Takeda.

4. Can DEXILANT expand into new markets? Yes, opportunities in Asia-Pacific and emerging economies could drive growth, provided Takeda addresses local regulatory and pricing demands.

5. How might future trends impact DEXILANT's financial outlook? Rising GERD prevalence and potential label expansions could boost revenue, but generic competition may limit gains to modest single-digit growth.

Sources Cited

1. Takeda Pharmaceuticals. Annual Report 2023. Available at: Takeda Investor Relations.
2. IQVIA Institute. Global Use of Medicines Report 2023. Available at: IQVIA Health Trends.
3. FDA Drug Database. Dexlansoprazole Label Updates, 2022. Available at: FDA.gov.