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Last Updated: December 26, 2024

DEXLANSOPRAZOLE Drug Patent Profile


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Which patents cover Dexlansoprazole, and what generic alternatives are available?

Dexlansoprazole is a drug marketed by Endo Operations, Mylan, and Twi Pharms. and is included in three NDAs.

The generic ingredient in DEXLANSOPRAZOLE 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 Dexlansoprazole

A generic version of DEXLANSOPRAZOLE was approved as dexlansoprazole by ENDO OPERATIONS on April 19th, 2017.

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Drug patent expirations by year for DEXLANSOPRAZOLE
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Recent Clinical Trials for DEXLANSOPRAZOLE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of KarachiPhase 1
SAMI Pharmaceutical, Karachi PakistanPhase 1
Taipei Veterans General Hospital, TaiwanN/A

See all DEXLANSOPRAZOLE clinical trials

Pharmacology for DEXLANSOPRAZOLE
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for DEXLANSOPRAZOLE
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
Endo Operations DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 202294-002 Jun 16, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 205205-002 Jan 19, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 202294-001 Apr 19, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 205205-001 Jan 19, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Twi Pharms DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 202666-002 Sep 16, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Twi Pharms DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 202666-001 Sep 16, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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