DEXILANT Drug Patent Profile

Which patents cover Dexilant, and when can generic versions of Dexilant launch?

Dexilant is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are twelve 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:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	31
Patent Applications:	515
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 seven 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	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes	8,173,158*PED				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	7,790,755*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	9,011,926		Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes	8,784,885*PED

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	9,145,389
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	022287-001	Jan 30, 2009	8,784,885*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	022287-002	Jan 30, 2009	8,784,885*PED
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	5,045,321*PED

International Patents for DEXILANT

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	169471	CONTROLLED RELEASE PREPARATION
World Intellectual Property Organization (WIPO)	2004083200
South Korea	20150084013	음식 섭취와 관계없이 위장 장애를 치료하는 방법 (METHODS OF TREATING GASTROINTESTINAL DISORDERS INDEPENDENT OF THE INTAKE OF FOOD)
Japan	2013155181	DEPOT PREPARATION
World Intellectual Property Organization (WIPO)	2004035020
Denmark	1553929
New Zealand	539353	Controlled release preparation

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	1490004-7	Sweden		PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 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	2014C/017	Belgium		PRODUCT NAME: DEXLANSOPRAZOL; AUTHORISATION NUMBER AND DATE: 47911 20131023
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	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	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

DEXILANT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexlansoprazole (DEXILANT)

Introduction to Dexlansoprazole (DEXILANT)

Dexlansoprazole, marketed under the brand name DEXILANT, is a proton pump inhibitor (PPI) used primarily for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, and other conditions related to excessive stomach acid.

Global Market Size and Growth

The global dexlansoprazole market was valued at USD 100 million in 2023 and is projected to reach USD 147 million by 2031, growing at a compound annual growth rate (CAGR) of 6% from 2024 to 2031[3].

Regional Market Analysis

North America

North America holds a significant share of the global dexlansoprazole market, accounting for more than 40% of the global revenue. The market in this region is expected to grow at a CAGR of 4.2% from 2024 to 2031. The growth is driven by increasing awareness of GERD, an aging population, and improvements in healthcare infrastructure[1].

Asia Pacific

The Asia Pacific region is experiencing rapid growth, with a CAGR of 8% from 2024 to 2031. This growth is attributed to the rising prevalence of GERD, an increasing senior population, and enhanced healthcare infrastructure. The extended-release formulation of dexlansoprazole is particularly appealing in this region due to its long-lasting symptom relief[1].

Europe

Europe's dexlansoprazole market is expected to grow at a CAGR of 4.5% from 2024 to 2031. The region's market expansion is fueled by the increasing incidence of GERD and the aging population, which is more susceptible to digestive disorders[1].

South America and Middle East & Africa

In South America, the market is projected to grow at a CAGR of 5.4%, while in the Middle East and Africa, it is expected to grow at a CAGR of 5.7% from 2024 to 2031. These regions are driven by rising awareness of GERD and the adoption of Western lifestyle habits, which contribute to an increase in GERD cases[1].

Key Drivers of Market Growth

Increasing Prevalence of GERD

The global rise in GERD cases is a significant driver of the dexlansoprazole market. As more people become aware of the condition and its treatment options, the demand for effective medications like dexlansoprazole increases[3].

Aging Population

The aging population is more prone to digestive disorders, including GERD. This demographic shift is driving the demand for long-term therapy with medications such as dexlansoprazole[3].

Advancements in Medication Formulation

Improvements in drug formulations, particularly the extended-release characteristics of dexlansoprazole, enhance patient compliance and efficacy. These advancements are crucial in driving market growth[3].

Healthcare Infrastructure and Spending

Enhanced healthcare infrastructure and increasing healthcare spending in developing regions are facilitating the growth of the dexlansoprazole market. Better access to modern medical care is leading to higher adoption rates of sophisticated pharmaceuticals like dexlansoprazole[3].

Financial Performance of Key Players

Devonian Health Group

Devonian Health Group, through its subsidiary Altius Healthcare, has seen significant financial growth driven by the launch of dexlansoprazole, the only authorized generic in Canada for GERD treatment. The company reported a 749% year-over-year increase in fourth-quarter revenues to $9 million and a 660% increase in annual revenues to $17.8 million. Despite an annual net loss, the company's cash position improved to $9.9 million, and debt was reduced to $2.08 million[2].

Market Segmentation

Product Types

The dexlansoprazole market is segmented by product types, including capsules, tablets, delayed-release capsules, oral suspension, and dispersible tablets. The extended-release formulations are particularly popular due to their long-lasting symptom relief[3].

Applications

The market is also segmented by application, including GERD, erosive esophagitis, heartburn, Zollinger-Ellison syndrome, and gastric ulcers. The versatility of dexlansoprazole in treating various acid-related conditions contributes to its market growth[3].

Competitive Landscape

The dexlansoprazole market includes both established and emerging players. Key companies are profiled based on the types of products they offer and other market-related factors. The report provides detailed information on the year of market entry for each player, offering valuable insights for research and analysis[3].

Impact of Pharmaceutical Innovations

Pharmaceutical innovations, such as better drug formulations and delivery systems, are enhancing patient compliance and efficacy. These advancements are crucial in the treatment of GERD and other acid-related conditions, driving the market forward.

"Pharmaceutical technology advancements are improving patient compliance and efficacy through better drug formulations and extended-release characteristics, which is driving market expansion."[3]

Economic and Social Factors

The economic and social landscapes of countries play a significant role in the market dynamics. Rising healthcare costs and improved access to modern medical care in developing nations are key factors driving the growth of the dexlansoprazole market[3].

Consumer Behavior

Consumer behavior, particularly the increasing awareness of GERD and its treatment options, is a significant driver of the market. As more people seek effective treatments, the demand for dexlansoprazole increases.

Key Takeaways

• The global dexlansoprazole market is projected to grow at a CAGR of 6% from 2024 to 2031.
• North America, Asia Pacific, and other regions are driving the market growth due to increasing GERD prevalence and an aging population.
• Advancements in medication formulation and healthcare infrastructure are key drivers.
• Devonian Health Group has seen significant financial growth driven by the launch of dexlansoprazole in Canada.
• The market is segmented by product types and applications, with extended-release formulations being particularly popular.

FAQs

What is the projected global market size for dexlansoprazole by 2031?

The global dexlansoprazole market is expected to reach USD 147 million by 2031[3].

What is the CAGR of the dexlansoprazole market in North America from 2024 to 2031?

The CAGR of the dexlansoprazole market in North America is 4.2% from 2024 to 2031[1].

Which region has the highest CAGR for the dexlansoprazole market?

The Asia Pacific region has the highest CAGR at 8% from 2024 to 2031[1].

What are the key drivers of the dexlansoprazole market growth?

Key drivers include the increasing prevalence of GERD, an aging population, advancements in medication formulation, and improved healthcare infrastructure[3].

Which company has seen significant financial growth due to the launch of dexlansoprazole?

Devonian Health Group has seen significant financial growth driven by the launch of dexlansoprazole in Canada[2].

Sources

1. Cognitive Market Research - Dexlansoprazole Market Report
2. Stock Titan - Devonian Reports Its Annual 2024 Financial Results
3. Market Research Intellect - Dexlansoprazole Market Size and Projections