DEXLANSOPRAZOLE - Generic Drug Details

What are the generic sources for dexlansoprazole and what is the scope of patent protection?

Dexlansoprazole is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Endo Operations, Mylan, and Twi Pharms, and is included in five NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexlansoprazole has one hundred and fifty-one patent family members in thirty-eight countries.

There are seventeen drug master file entries for dexlansoprazole. Nine suppliers are listed for this compound.

Summary for DEXLANSOPRAZOLE

International Patents:	151
US Patents:	12
Tradenames:	3
Applicants:	4
NDAs:	5
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	51
Patent Applications:	881
Drug Prices:	Drug price trends for DEXLANSOPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXLANSOPRAZOLE
What excipients (inactive ingredients) are in DEXLANSOPRAZOLE?	DEXLANSOPRAZOLE excipients list
DailyMed Link:	DEXLANSOPRAZOLE at DailyMed

See drug prices for DEXLANSOPRAZOLE

Recent Clinical Trials for DEXLANSOPRAZOLE

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 DEXLANSOPRAZOLE clinical trials

Pharmacology for DEXLANSOPRAZOLE

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for DEXLANSOPRAZOLE

Anti-Ulcer Agents

Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DEXLANSOPRAZOLE

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DEXLANSOPRAZOLE

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 DEXLANSOPRAZOLE

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	022287-002	Jan 30, 2009	AB	RX	Yes	Yes
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes			Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No			Y
Endo Operations	DEXLANSOPRAZOLE	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	202294-002	Jun 16, 2022	AB	RX	No	No
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes			Y
Twi Pharms	DEXLANSOPRAZOLE	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	202666-002	Sep 16, 2022	AB	RX	No	No
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes					Y

Expired US Patents for DEXLANSOPRAZOLE

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 SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016
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	022287-001	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

International Patents for DEXLANSOPRAZOLE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	021792	ТВЕРДЫЙ ПРЕПАРАТ, РАСТВОРЯЮЩИЙСЯ ВО РТУ (ORALLY-DISINTEGRATING SOLID PREPARATION)
Japan	2011235172	METHOD FOR PRODUCING GRANULES
China	104127368	Orally-disintergrating solid preparation
Canada	2702356	PROCEDES DE TRAITEMENT DE TROUBLES GASTRO-INTESTINAUX INDEPENDANTS DE LA PRISE ALIMENTAIRE (METHODS OF TREATING GASTROINTESTINAL DISORDERS INDEPENDENT OF THE INTAKE OF FOOD)
Spain	2392960
Uruguay	31698	PREPARACION SOLIDA DE DESINTEGRACION ORAL
Taiwan	201125563	Controlled release preparation

Supplementary Protection Certificates for DEXLANSOPRAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

DEXLANSOPRAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexlansoprazole

Introduction to Dexlansoprazole

Dexlansoprazole, a proton pump inhibitor (PPI), is a significant player in the treatment of gastroesophageal reflux disease (GERD) and other acid-related disorders. Its unique dual delayed-release formulation sets it apart from other PPIs, providing extended symptom relief.

Global Market Size and Growth

The global dexlansoprazole market is projected to grow substantially over the next few years. As of 2023, the market size was valued at USD 100 million and is expected to reach USD 147 million by 2031, growing at a compound annual growth rate (CAGR) of 6% from 2024 to 2031[4].

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 advancements in healthcare infrastructure[1].

Asia Pacific

The Asia Pacific region is experiencing rapid growth, with a CAGR of 8% from 2024 to 2031. This region accounts for around 23% of the global revenue. The rising prevalence of GERD, a growing senior population, and improvements in healthcare infrastructure are key factors driving this growth[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 increasing GERD cases and an aging population, which is more prone 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 will grow at a CAGR of 5.7% from 2024 to 2031. These regions are driven by rising awareness of GERD and changing lifestyles that increase the risk of acid-related diseases[1].

Key Drivers of Market Growth

Increasing Prevalence of GERD and Peptic Ulcers

The global rise in GERD and peptic ulcer cases is a major driver of the dexlansoprazole market. As more people become aware of the benefits of PPIs, the demand for efficient acid suppression medications like dexlansoprazole is increasing[4].

Aging Population

The growing elderly population is more vulnerable to digestive disorders, which has led to an increased demand for medications such as dexlansoprazole. This demographic shift is a significant factor in market expansion[4].

Advancements in Pharmaceutical Technology

Improvements in medication formulation and delivery systems, particularly the dual delayed-release formulation of dexlansoprazole, enhance patient compliance and efficacy. These advancements are driving market growth by offering better treatment options[5].

Healthcare Infrastructure and Spending

The expansion of healthcare infrastructure and increased 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[4].

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. In the fourth quarter of 2024, the company reported a 749% year-over-year increase in revenues, reaching $9 million, and an annual revenue increase of 660% to $17.8 million. This growth has improved the company's cash position to $9.9 million and reduced its debt to $2.08 million[2].

Challenges and Considerations

COVID-19 Impact

The COVID-19 pandemic had a temporary impact on the proton pump inhibitors market, including dexlansoprazole, as patients were advised to reduce their use of these medications unless absolutely necessary. However, with the pandemic subsiding, the market is expected to experience favorable growth[3].

Adverse Effects and Cost Considerations

Dexlansoprazole, like other PPIs, has common adverse effects such as diarrhea, abdominal pain, and nausea. Additionally, the cost of dexlansoprazole is not favorable compared to other agents, necessitating further studies to evaluate its potential advantages[5].

Market Segmentation

The dexlansoprazole market is segmented based on product type (capsules, tablets, delayed-release capsules, oral suspension, dispersible tablets) and application (GERD, erosive esophagitis, heartburn, Zollinger-Ellison syndrome, gastric ulcers). This segmentation helps in understanding the specific needs and trends within different market segments[4].

Conclusion

The dexlansoprazole market is poised for significant growth driven by increasing GERD prevalence, an aging population, and advancements in pharmaceutical technology. Regional markets, particularly in North America and the Asia Pacific, are expected to contribute substantially to this growth. Despite challenges such as the COVID-19 pandemic and cost considerations, the market is anticipated to expand as healthcare infrastructure improves and awareness of acid-related diseases increases.

Key Takeaways

• The global dexlansoprazole market is expected to grow at a CAGR of 6% from 2024 to 2031.
• North America and the Asia Pacific are key regions driving market growth.
• Increasing GERD prevalence and an aging population are major market drivers.
• Advancements in pharmaceutical technology and healthcare infrastructure are crucial for market expansion.
• Devonian Health Group has seen significant financial growth due to dexlansoprazole sales.

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[4].

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?

Key drivers include the increasing prevalence of GERD, an aging population, and advancements in pharmaceutical technology[4].

How has the COVID-19 pandemic affected the dexlansoprazole market?

The pandemic temporarily reduced the use of PPIs, including dexlansoprazole, but the market is expected to recover as the pandemic subsides[3].

What are the common adverse effects of dexlansoprazole?

Common adverse effects include diarrhea, abdominal pain, nausea, upper respiratory infection, vomiting, and flatulence[5].

Sources

1. Cognitive Market Research: Dexlansoprazole Market Report.
2. Stock Titan: Devonian Reports Its Annual 2024 Financial Results.
3. Mordor Intelligence: Proton Pump Inhibitors Market Size.
4. Market Research Intellect: Global Dexlansoprazole Market.
5. Science.gov: Dexlansoprazole Modified Release.