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Last Updated: March 30, 2025

DEXAMETHASONE INTENSOL Drug Patent Profile


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

Dexamethasone Intensol is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in DEXAMETHASONE INTENSOL is dexamethasone. There are thirty-nine drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dexamethasone Intensol

A generic version of DEXAMETHASONE INTENSOL was approved as dexamethasone by HIKMA on September 15th, 1983.

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Drug patent expirations by year for DEXAMETHASONE INTENSOL
Drug Prices for DEXAMETHASONE INTENSOL

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Recent Clinical Trials for DEXAMETHASONE INTENSOL

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

SponsorPhase
Mayo ClinicPhase 1
Southwest Oncology GroupPhase 3
University of Southern CaliforniaPhase 1/Phase 2

See all DEXAMETHASONE INTENSOL clinical trials

Pharmacology for DEXAMETHASONE INTENSOL

US Patents and Regulatory Information for DEXAMETHASONE INTENSOL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hikma DEXAMETHASONE INTENSOL dexamethasone CONCENTRATE;ORAL 088252-001 Sep 1, 1983 RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

EU/EMA Drug Approvals for DEXAMETHASONE INTENSOL

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
AbbVie Deutschland GmbH & Co. KG Ozurdex dexamethasone EMEA/H/C/001140
Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
Authorised no no no 2010-07-26
THERAVIA Neofordex dexamethasone EMEA/H/C/004071
Treatment of multiple myeloma.
Authorised no no no 2016-03-16
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Dexamethasone Intensol

Market Overview

Dexamethasone, a potent anti-inflammatory synthetic adrenal corticosteroid, has seen significant growth in recent years, particularly due to its critical role in managing COVID-19 and various other inflammatory and autoimmune conditions.

Market Size and Growth

The global dexamethasone market is projected to reach USD 4,634.01 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 6.65% from 2021 to 2028. This growth is driven by several key factors, including the increasing prevalence of viral disease outbreaks, the high incidence of inflammatory conditions, and the robust investment in research and development[1].

Segmentation of the Market

Formulation Type

The dexamethasone market is segmented into various formulation types, including liquid, tablet, solution for injection, and other forms. Dexamethasone Intensol Oral Solution, for example, is a concentrated oral solution that offers flexible dosing adjustments, making it a preferred choice for managing acute and chronic inflammatory conditions[2].

Patient Type

The market is also segmented based on patient type, which includes adult, pediatric, and geriatric patients. Dexamethasone is used across all these age groups to treat a variety of conditions, from allergic reactions and asthma in children to adrenal insufficiency and cancer in adults[2][3].

Application

Dexamethasone is applied in a wide range of therapeutic areas, including anti-inflammatory and immunosuppressant effects, respiratory distress syndrome, COVID-19, and other conditions. Its effectiveness in reducing mortality in critically ill COVID-19 patients has significantly boosted its demand[1][3][4].

End Users

The end users of dexamethasone include hospitals, clinics, pharmacy & drug stores, and online pharmacies. The North America region leads the market due to the high prevalence of diseases and the rapid increase in COVID-19 cases, while the Asia-Pacific region is expected to expand at a significant growth rate due to the strong presence of major manufacturers[1].

Drivers of Market Growth

Increasing Prevalence of Inflammatory Conditions

The rising incidence of inflammatory and autoimmune disorders such as rheumatoid arthritis, bronchospasm, and multiple sclerosis is driving the demand for dexamethasone. Its broad anti-inflammatory activities make it a crucial treatment option for these conditions[3][4].

COVID-19 Pandemic

The COVID-19 pandemic has been a significant driver of the dexamethasone market. Studies, such as the Oxford University RECOVERY Trial, have shown that dexamethasone can reduce deaths by about a third in patients on ventilators and by about a fifth in patients on oxygen, leading to its widespread use in treating critically ill COVID-19 patients[3][4].

Robust Investment in Research and Development

Continuous investment in research and development is contributing to the growth of the dexamethasone market. New formulations and applications, such as intravitreal steroid implants for ocular conditions, are expanding the market's scope[1].

Challenges and Restraints

Side Effects and Adverse Reactions

Despite its therapeutic benefits, dexamethasone is associated with several side effects, including insomnia, acne, fluid retention, electrolyte imbalances, and adrenal suppression. These adverse effects can impede the market growth[4].

Preventive Measures and Vaccines

The development and distribution of vaccines and other preventive measures for viral diseases could potentially reduce the demand for dexamethasone, posing a challenge to the market's growth[1].

Financial Trajectory

Cost and Pricing

The cost of dexamethasone can vary based on several factors, including the treatment plan, insurance coverage, pharmacy used, and any necessary equipment. The availability of savings programs and financial assistance can also impact the financial burden on patients[5].

Revenue Projections

Given the projected market size of USD 4,634.01 million by 2028, the revenue from dexamethasone sales is expected to increase significantly. This growth will be driven by the increasing demand for the drug across various therapeutic applications and regions[1].

Regional Analysis

North America

North America currently leads the dexamethasone market due to the high prevalence of diseases and the rapid increase in COVID-19 cases. The region's advanced healthcare infrastructure and high adoption rate of new treatments also contribute to its market dominance[1].

Asia-Pacific

The Asia-Pacific region is expected to grow at a significant rate due to the rising prevalence of viral disease outbreaks and the strong presence of major manufacturers. Countries like China, India, and Japan are key contributors to this growth[1].

Healthcare Infrastructure and Technology Penetration

Advanced Formulations

The development of advanced formulations such as Dexamethasone Intensol Oral Solution, which offers concentrated and easily absorbable doses, is enhancing the market. These formulations provide precise dosing and are patient-friendly, making them a preferred choice for managing inflammatory conditions[2].

New Technology Penetration

The penetration of new technologies, such as intravitreal steroid implants, is expanding the therapeutic applications of dexamethasone. These innovations are crucial for treating ocular conditions like diabetic macular edema and central retinal vein occlusion[3].

Key Takeaways

  • The global dexamethasone market is projected to reach USD 4,634.01 million by 2028, growing at a CAGR of 6.65%.
  • The market is driven by the increasing prevalence of inflammatory conditions, the COVID-19 pandemic, and robust investment in research and development.
  • Dexamethasone is used in various formulations and applications, including anti-inflammatory and immunosuppressant effects, respiratory distress syndrome, and COVID-19 treatment.
  • The North America region leads the market, while the Asia-Pacific region is expected to grow significantly.
  • Despite its benefits, dexamethasone is associated with several side effects, which can impede market growth.

FAQs

Q: What are the primary therapeutic applications of dexamethasone?

A: Dexamethasone is used to treat various inflammatory and autoimmune conditions, including rheumatoid arthritis, bronchospasm, multiple sclerosis, and COVID-19. It is also used in dental surgery, croup in children, and as a test for adrenal gland disorders[3].

Q: How has the COVID-19 pandemic impacted the dexamethasone market?

A: The COVID-19 pandemic has significantly boosted the demand for dexamethasone due to its effectiveness in reducing mortality in critically ill patients. Studies like the Oxford University RECOVERY Trial have highlighted its benefits in this context[3][4].

Q: What are the common side effects associated with dexamethasone?

A: Common side effects include insomnia, acne, fluid retention, electrolyte imbalances, and adrenal suppression. Long-term use can also lead to osteoporosis, steroid-induced osteonecrosis, and other serious adverse effects[4].

Q: How does the cost of dexamethasone vary?

A: The cost of dexamethasone can vary based on factors such as treatment plan, insurance coverage, pharmacy used, and any necessary equipment. Savings programs and financial assistance can also impact the cost[5].

Q: Which regions are expected to drive the growth of the dexamethasone market?

A: North America currently leads the market, while the Asia-Pacific region is expected to grow significantly due to the rising prevalence of viral disease outbreaks and the strong presence of major manufacturers[1].

Sources

  1. Data Bridge Market Research: Global Dexamethasone Market – Industry Trends and Forecast to 2028.
  2. Mountainside Medical: Dexamethasone Intensol Oral Solution (Concentrated) 30 mL Bottle 1 mg/mL.
  3. Wikipedia: Dexamethasone.
  4. NCBI Bookshelf: Dexamethasone - StatPearls.
  5. Medical News Today: Dexamethasone cost: Financial assistance, savings, more.

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