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. Nine 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 ENDO OPERATIONS on April 19^th, 2017.

Summary for DEXILANT SOLUTAB

International Patents:	50
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	61
Patent Applications:	515
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	9,145,389
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	7,875,292*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	7,431,942*PED
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	7,285,668*PED

International Patents for DEXILANT SOLUTAB

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2345650
Hong Kong	1054380	(R)-或(S)-蘭索那唑的結晶化方法 (PROCESS FOR THE CRYSTALLIZATION OF (R)- OR (S)-LANSOPRAZOLE)
New Zealand	539353	Controlled release preparation
Peru	20110544	FORMULACION FARMACEUTICA DE LIBERACION CONTROLADA QUE COMPRENDE ISOMERO R DE LANSOPRAZOL
Portugal	1129088

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	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	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	C01129088/01	Switzerland		PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
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

Market Dynamics and Financial Trajectory for DEXILANT SOLUTAB

Introduction

DEXILANT SOLUTAB, a formulation of dexlansoprazole, is a proton pump inhibitor (PPI) that has been approved by the FDA for the treatment of various gastrointestinal conditions. This article delves into the market dynamics and financial trajectory of DEXILANT SOLUTAB, highlighting its indications, market size, growth drivers, and challenges.

Indications and Usage

DEXILANT SOLUTAB is indicated for several key conditions:

• Healing of Erosive Esophagitis (EE): It is used to heal all grades of EE for up to 8 weeks[1][2][5].
• Maintenance of Healed EE and Relief of Heartburn: It maintains the healing of EE and provides relief from heartburn for up to 6 months[1][2][5].
• Treatment of Heartburn Associated with Symptomatic Non-Erosive GERD: It treats heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks[1][2][5].

Market Size and Projections

The market for dexlansoprazole, including DEXILANT SOLUTAB, is part of the broader proton pump inhibitors (PPIs) market. Here are some key market size and projection figures:

• Dexlansoprazole Market: The dexlansoprazole market was valued at USD 100 million in 2023 and is expected to reach USD 147 million by 2031, growing at a CAGR of 6% from 2024 to 2031[3].
• PPIs Market: The overall PPIs market is estimated to be USD 12.70 billion in 2024 and is expected to reach USD 16.32 billion by 2029, growing at a CAGR of 5.14% during the forecast period[4].

Growth Drivers

Several factors are driving the growth of the dexlansoprazole market and, by extension, DEXILANT SOLUTAB:

• Increasing Prevalence of GERD and Peptic Ulcers: The global increase in cases of GERD and peptic ulcers is a significant driver. These conditions require efficient acid suppression medication, which PPIs like dexlansoprazole provide[3][4].
• Aging Population: The growing elderly population is more prone to digestive disorders, increasing the demand for medications like DEXILANT SOLUTAB[3].
• Advancements in Medication Formulation: Improvements in drug formulations and delivery systems, such as the orally disintegrating tablets of DEXILANT SOLUTAB, enhance patient compliance and efficacy[2][3].
• Expanding Healthcare Access: Improved access to modern medical care in developing regions is also driving market growth[3].

Competitive Landscape

The PPIs market is highly competitive, with several major players:

• Takeda Pharmaceuticals: As the manufacturer of DEXILANT SOLUTAB, Takeda has a significant presence in the gastroenterology market. The company's over 20 years of leadership in this field has enabled it to offer innovative formulations like DEXILANT SOLUTAB[2].
• Other Market Players: Companies like Xiromed LLC, Insud Pharmaceuticals, and AstraZeneca are also active in the PPIs market, launching generic and branded products that compete with DEXILANT SOLUTAB[4].

Challenges and Considerations

Despite the growth potential, there are several challenges and considerations:

• COVID-19 Impact: The COVID-19 pandemic had a temporary impact on the PPIs market, as patients were advised to reduce their use of these medications unless absolutely necessary. However, as the pandemic subsides, the market is expected to recover[4].
• Side Effects and Generic Competition: PPIs, including dexlansoprazole, have been associated with side effects such as an increased risk of COVID-19 infection and poor outcomes. Additionally, the increasing use of generic products can hamper the growth of branded medications like DEXILANT SOLUTAB[4].

Patient Compliance and Innovation

DEXILANT SOLUTAB's unique formulation as an orally disintegrating tablet is a significant innovation:

• Dual Delayed Release (DDR) Technology: This technology provides two separate releases of medication, enhancing the drug's efficacy and patient compliance[1][2].
• Ease of Use: The melt-in-your-mouth tablet is particularly beneficial for patients who struggle with swallowing capsules, expanding the patient base for DEXILANT SOLUTAB[2].

Financial Performance and Projections

The financial performance of DEXILANT SOLUTAB is closely tied to the overall PPIs market and the specific market for dexlansoprazole:

• Historical Performance: Since its approval, DEXILANT capsules have had over 25 million prescriptions filled, indicating a strong market presence[2].
• Future Projections: With the market for dexlansoprazole expected to grow at a CAGR of 6% from 2024 to 2031, DEXILANT SOLUTAB is poised for continued financial growth[3].

Regulatory Approvals and Clinical Trials

The FDA approval of DEXILANT SOLUTAB was based on several clinical trials:

• Bioequivalence: The approval was granted after establishing bioequivalence to the DEXILANT 30 mg capsule[5].
• Pediatric Trials: Clinical trials in pediatric patients aged 12 to 17 years were conducted to evaluate the safety and effectiveness of dexlansoprazole for various indications[5].

Key Takeaways

• Strong Market Presence: DEXILANT SOLUTAB has a solid market presence due to its effective treatment of GERD and EE.
• Innovative Formulation: The orally disintegrating tablet formulation enhances patient compliance.
• Growing Market: The market for dexlansoprazole is expected to grow significantly due to increasing prevalence of GERD and peptic ulcers.
• Challenges: The market faces challenges such as side effects and generic competition.

FAQs

What is DEXILANT SOLUTAB used for?

DEXILANT SOLUTAB is used for the healing of erosive esophagitis (EE), maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)[1][2][5].

What is the unique feature of DEXILANT SOLUTAB?

DEXILANT SOLUTAB features dual delayed release (DDR) technology and is available as an orally disintegrating tablet, making it easier for patients who struggle with swallowing capsules[1][2].

How big is the market for dexlansoprazole?

The dexlansoprazole market was valued at USD 100 million in 2023 and is expected to reach USD 147 million by 2031, growing at a CAGR of 6% from 2024 to 2031[3].

What are the growth drivers for the dexlansoprazole market?

The growth drivers include the increasing prevalence of GERD and peptic ulcers, an aging population, advancements in medication formulation, and expanding healthcare access in developing regions[3][4].

Are there any challenges facing the PPIs market, including DEXILANT SOLUTAB?

Yes, challenges include side effects associated with PPIs, the impact of COVID-19 on medication use, and increasing competition from generic products[4].

Sources

1. Takeda Pharmaceuticals U.S.A., Inc. - FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)[1].
2. PR Newswire - FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)[2].
3. Market Research Intellect - Dexlansoprazole Market Size and Projections[3].
4. Mordor Intelligence - Proton Pump Inhibitors Market - PPIS - Size, Share & Analysis[4].
5. FDA - Cross-Discipline Team Leader Review of Dexilant (dexlansoprazole)[5].