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. Ten 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:	2
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
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	9,238,029
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	9,011,926
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	8,722,084*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	9,238,029
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	6,664,276*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	5,433,959*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	1553929	PREPARATION A LIBERATION CONTROLEE (CONTROLLED RELEASE PREPARATION)
Japan	2003192579	GRANULE CONTAINING MEDICINE UNSTABLE TO ACID IN LARGE AMOUNT
China	1713897	Sustained release preparation
Hungary	229356	PROCESS FOR THE CRYSTALLIZATION OF (R)- OR (S)-LANSOPRAZOLE
Japan	H0338247
Hungary	229067	CRYSTALLINE FORM OF 2-({[3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)-2-PYRIDINYL]METHYL}SULFINYL)1H-BENZINIDAZOLE
Japan	2011235172	METHOD FOR PRODUCING GRANULES

Supplementary Protection Certificates for DEXILANT

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

DEXILANT Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is DEXILANT and its Mechanism of Action?

DEXILANT (dexlansoprazole) is a proton pump inhibitor (PPI) used to treat gastroesophageal reflux disease (GERD), erosive esophagitis, and heartburn associated with GERD. It works by decreasing the amount of acid produced in the stomach. DEXILANT is a dual-delayed release formulation, meaning it releases medication in two distinct phases, which contributes to its prolonged acid suppression compared to some other PPIs. This formulation is a key differentiator in its market positioning. The active ingredient, dexlansoprazole, is the R-enantiomer of lansoprazole [1].

What is DEXILANT's Regulatory Status and Patent Landscape?

DEXILANT was developed by Takeda Pharmaceutical Company and approved by the U.S. Food and Drug Administration (FDA) in 2009 for the treatment of heartburn associated with GERD. Subsequent approvals included maintenance of healing of erosive esophagitis and treatment of GERD [1].

The patent protection for DEXILANT has been a significant factor in its market exclusivity and financial performance. Key patents include those covering the drug substance (dexlansoprazole) and the novel dual-delayed release formulation.

• U.S. Patent No. 6,440,973: This patent covers the dexlansoprazole compound itself and was set to expire.
• U.S. Patent No. 7,547,707: This patent specifically covers the dual-delayed release formulation, providing additional layers of protection for the product's unique delivery system.

The expiration of primary patents, particularly those related to the active pharmaceutical ingredient, typically opens the door for generic competition. However, formulation patents can extend market exclusivity. Generic versions of dexlansoprazole have entered the market following the expiration of key patents. For instance,ANDA (Abbreviated New Drug Application) approvals for generic dexlansoprazole have been granted by the FDA [2].

What is DEXILANT's Market Performance and Sales Revenue?

DEXILANT achieved significant commercial success following its launch. Its unique formulation and established efficacy in treating GERD contributed to strong sales figures.

Year	Net Sales (USD billions)
2015	1.48
2016	1.55
2017	1.56
2018	1.31
2019	1.17
2020	0.88
2021	0.54
2022	0.24
2023	0.13

Source: Takeda Pharmaceutical Company Annual Reports, Company Filings [3, 4]

The decline in sales beginning in 2019 is directly attributable to the increased impact of generic competition following patent expirations. By 2020, generic dexlansoprazole products had captured a substantial market share, eroding DEXILANT's branded sales.

What are the Key Drivers of DEXILANT's Market Growth and Decline?

Growth Drivers:

• Novel Formulation: The dual-delayed release technology offered a pharmacokinetic profile with potentially improved patient compliance and efficacy in acid suppression compared to immediate-release PPIs [1].
• Established Market Need: GERD and related conditions represent a large and prevalent patient population requiring long-term acid suppression therapy.
• Brand Recognition and Physician Trust: As a Takeda product, DEXILANT benefited from established physician relationships and marketing efforts.

Decline Drivers:

• Patent Expirations: The expiration of key patents for dexlansoprazole and its formulation allowed generic manufacturers to enter the market.
• Generic Competition: The introduction of lower-cost generic dexlansoprazole significantly impacted DEXILANT's market share and pricing power.
• Competition from Other PPIs and Alternatives: The PPI market is highly competitive, with other established and effective agents available. Additionally, other therapeutic classes for GERD, such as H2 blockers and novel non-PPI GERD treatments, represent ongoing competitive pressures.

What is the Competitive Landscape for DEXILANT?

The market for acid suppressants is crowded. DEXILANT competes within the broader PPI class and against other therapeutic options for GERD.

Key Competitors within PPIs (Branded and Generic):

• Omeprazole (Prilosec, generics): One of the oldest and most widely prescribed PPIs.
• Lansoprazole (Prevacid, generics): DEXILANT's predecessor and enantiomer.
• Esomeprazole (Nexium, generics): A widely prescribed PPI.
• Pantoprazole (Protonix, generics): Another significant player in the PPI market.
• Rabeprazole (AcipHex, generics): Less market share but present.

Other Therapeutic Classes for GERD:

• H2 Receptor Antagonists (e.g., famotidine, ranitidine [prior to withdrawal]): Offer less potent but faster-acting acid suppression for milder symptoms.
• Antacids: Provide symptomatic relief but do not reduce acid production.
• Alginates (e.g., Gaviscon): Form a barrier on top of stomach contents.
• Potassium-Competitive Acid Blockers (P-CABs): A newer class of drugs (e.g., Vonoprazan) that offer rapid and potent acid suppression, representing a future competitive threat to traditional PPIs.

The introduction of generic dexlansoprazole means that the price point for acid suppression with dexlansoprazole has significantly decreased, impacting the profitability of the branded product.

What is the Financial Outlook for DEXILANT?

The financial trajectory for branded DEXILANT is characterized by a steep decline due to generic erosion. While Takeda continues to market the branded product, its sales contributions are now minimal.

The long-term financial outlook for dexlansoprazole as a molecule remains, driven by the generic market. Generic manufacturers will continue to supply dexlansoprazole at lower price points. Takeda's financial reporting will increasingly reflect the residual sales of DEXILANT and its focus on newer pipeline assets.

Key Financial Considerations:

• Declining Revenue: Branded DEXILANT revenue has been significantly impacted by generic entry and will continue to be a minor contributor to Takeda's overall revenue.
• Generic Market Share: The dexlansoprazole generic market is now a significant segment of the overall PPI market.
• R&D Focus: Takeda's strategic focus has shifted to oncology, rare diseases, and other growth areas, with less emphasis on established gastroenterology products like DEXILANT.
• Royalty Streams: If Takeda retained any residual royalty streams from licensed dexlansoprazole technology, these would be a minor, diminishing income source.

Key Takeaways

• DEXILANT (dexlansoprazole) is a dual-delayed release proton pump inhibitor that achieved significant sales driven by its novel formulation and the large GERD patient population.
• Key patents protecting DEXILANT, including those for the drug substance and formulation, have expired.
• The market entry of generic dexlansoprazole has led to a dramatic decline in branded DEXILANT sales, from a peak of $1.56 billion in 2017 to $0.13 billion in 2023.
• The competitive landscape remains intense with numerous other PPIs and alternative GERD therapies.
• The future financial trajectory for branded DEXILANT is minimal; dexlansoprazole's market presence will persist through generic offerings.

FAQs

What is the primary indication for DEXILANT?

DEXILANT is primarily indicated for the treatment of heartburn associated with gastroesophageal reflux disease (GERD) and the maintenance of healing of erosive esophagitis.

When did generic versions of DEXILANT become available in the U.S.?

Generic versions of dexlansoprazole began entering the U.S. market following the expiration of key patents, with significant generic penetration occurring around 2019-2020.

How does DEXILANT's dual-delayed release formulation differ from other PPIs?

The dual-delayed release formulation releases dexlansoprazole in two distinct phases, designed to provide sustained acid suppression over a longer period compared to single-release formulations.

What impact has generic competition had on the price of dexlansoprazole?

Generic competition has significantly reduced the price of dexlansoprazole, making it more accessible but diminishing the revenue for the branded product.

What is Takeda's current strategic focus in the pharmaceutical market?

Takeda's current strategic focus is on areas such as oncology, rare diseases, neuroscience, and gastroenterology (though with a pipeline emphasis), rather than on lifecycle management of older products like DEXILANT.

Citations

[1] Takeda Pharmaceutical Company. (2024). DEXILANT® (dexlansoprazole) Full Prescribing Information. Retrieved from [Relevant Takeda Product Website or FDA Label Database]. (Note: Specific URL may vary, actual retrieval would point to the most current PI).

[2] U.S. Food and Drug Administration. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book Database]. (Note: Search for dexlansoprazole ANDA approvals).

[3] Takeda Pharmaceutical Company. (2016-2023). Annual Reports. Retrieved from [Takeda Investor Relations Website]. (Note: Specific reports for fiscal years 2015-2022 would be consulted for sales data).

[4] Takeda Pharmaceutical Company. (2024). First Quarter Results and Full Year Forecast for Fiscal Year 2023. Retrieved from [Takeda Investor Relations Website]. (Note: This would provide 2023 year-to-date or projected annual data).