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Last Updated: December 22, 2024

DEXAMETHASONE SODIUM PHOSPHATE Drug Patent Profile


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When do Dexamethasone Sodium Phosphate patents expire, and what generic alternatives are available?

Dexamethasone Sodium Phosphate is a drug marketed by Amneal, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Gland Pharma Ltd, Hikma, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz. and is included in forty NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Dexamethasone Sodium Phosphate

A generic version of DEXAMETHASONE SODIUM PHOSPHATE was approved as dexamethasone sodium phosphate by HIKMA on September 7th, 1982.

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Drug patent expirations by year for DEXAMETHASONE SODIUM PHOSPHATE
Recent Clinical Trials for DEXAMETHASONE SODIUM PHOSPHATE

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

SponsorPhase
BiotrialPhase 3
Quince Therapeutics S.p.A.Phase 3
Vietstar Biomedical ResearchN/A

See all DEXAMETHASONE SODIUM PHOSPHATE clinical trials

Pharmacology for DEXAMETHASONE SODIUM PHOSPHATE
Anatomical Therapeutic Chemical (ATC) Classes for DEXAMETHASONE SODIUM PHOSPHATE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A06AD Osmotically acting laxatives
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A06AG Enemas
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
B05XA Electrolyte solutions
B05X I.V. SOLUTION ADDITIVES
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
V03AG Drugs for treatment of hypercalcemia
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various

US Patents and Regulatory Information for DEXAMETHASONE SODIUM PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 040491-001 Apr 11, 2003 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 087668-001 Jul 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Parenteral DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 081125-001 Aug 31, 1990 DISCN 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

DEXAMETHASONE SODIUM PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexamethasone Sodium Phosphate

Market Overview

Dexamethasone sodium phosphate, a potent corticosteroid, is experiencing significant growth in the pharmaceutical market due to its wide-ranging therapeutic applications. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The dexamethasone sodium phosphate injection market is projected to reach USD 200.21 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.8% from 2024 to 2031. This growth is driven by the increasing prevalence of chronic diseases, advancements in healthcare infrastructure, and a rising emphasis on patient-centric care[1].

End-User Segmentation

Hospitals

Hospitals are a significant segment of the market, given their advanced facilities for administering injectable medications. They cater to patients in emergency care, surgical recovery, and intensive care units, where dexamethasone sodium phosphate is often used to manage severe symptoms and inflammatory conditions[1].

Clinics

Clinics also represent a substantial share of the market, focusing on outpatient care. They serve specific populations, such as pediatrics and geriatrics, where the anti-inflammatory properties of dexamethasone sodium phosphate are particularly beneficial[1].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies play a crucial role in ensuring the availability of dexamethasone sodium phosphate, especially for severe conditions requiring immediate treatment. They often engage in bulk purchasing, which helps in maintaining competitive pricing and ensuring drug availability during public health emergencies[1].

Retail Pharmacies

Retail pharmacies provide accessible healthcare solutions to the general public, catering to both prescription and over-the-counter needs. They act as community health resources, making dexamethasone sodium phosphate more accessible[1].

Online Pharmacies

Online pharmacies are another growing channel, offering convenience and accessibility, especially for patients who prefer home delivery or have mobility issues[1].

Geographical Segmentation

North America

North America, including the United States and Canada, is characterized by advanced healthcare infrastructure and a high prevalence of chronic diseases. This region is a hub for extensive research activities and is home to key players in the pharmaceutical industry[1].

Europe

Europe has a robust regulatory environment and a growing focus on healthcare advancements. Countries like Germany, the UK, and France drive the demand for corticosteroid therapies, contributing to the market's growth[1].

Asia-Pacific

The Asia-Pacific region, particularly countries like China and India, is experiencing rapid economic growth and increasing health expenditures. This has led to a surge in demand for dexamethasone sodium phosphate due to rising incidences of respiratory diseases and other inflammatory conditions[1].

Latin America and Middle East & Africa

Latin America is gradually emerging due to increasing healthcare investments and urbanization, while the Middle East and Africa exhibit a mixed landscape with developing healthcare systems and a rising prevalence of diseases[1].

Market Drivers

  • Increasing Prevalence of Chronic Diseases: The growing number of patients with chronic diseases such as autoimmune disorders and respiratory diseases drives the demand for dexamethasone sodium phosphate[1][3].
  • Advancements in Healthcare Infrastructure: Improvements in healthcare facilities, especially in hospitals and clinics, enhance the ability to administer and manage treatments involving dexamethasone sodium phosphate[1].
  • Patient-Centric Care: The increasing emphasis on patient-centric care models leads to higher demand for effective and manageable treatments like dexamethasone sodium phosphate[1].

Market Restraints

  • Regulatory Frameworks: Stringent regulatory requirements can slow down the approval and distribution of dexamethasone sodium phosphate, particularly in regions with strict healthcare regulations[3].
  • Economic Factors: Economic instability and varying healthcare expenditures across different regions can impact the market's growth rate[3].

Financial Trajectory

Revenue Projections

The market is expected to grow from USD 121.21 million in 2023 to USD 200.21 million by 2031, with a CAGR of 5.8% during the forecast period[1].

Investment and Funding

Companies like Quince Therapeutics are investing heavily in clinical trials and research related to dexamethasone sodium phosphate. For instance, Quince Therapeutics has a strong cash position expected to fund its Phase 3 NEAT clinical trial and other development activities through 2026[2][5].

Clinical Trials and Development

The ongoing Phase 3 NEAT clinical trial by Quince Therapeutics, evaluating the neurological effects of EryDex (dexamethasone sodium phosphate encapsulated in autologous red blood cells) in patients with Ataxia-Telangiectasia, is a significant financial and developmental milestone. The trial is expected to be fully funded through the company's existing cash runway[2][5].

Competitive Landscape

The market is competitive, with several key players focusing on strengthening their product portfolios and expanding their business globally. Companies like Waterstone Technology and Shenzhen Simeiquan Biotechnology are among those actively involved in the market[4].

Market Opportunities

  • Rare Diseases: The potential treatment of rare diseases like Ataxia-Telangiectasia represents a significant market opportunity, with Quince Therapeutics estimating a $1+ billion peak commercial opportunity globally[2][5].
  • Technological Advancements: Innovations in drug delivery systems, such as the Autologous Intracellular Drug Encapsulation (AIDE) technology by Quince Therapeutics, offer new avenues for market growth[2][5].

Challenges

  • Regulatory Approvals: Securing regulatory approvals, especially for new indications or delivery systems, can be challenging and time-consuming[3].
  • Market Competition: The competitive nature of the pharmaceutical market means that companies must continuously innovate and differentiate their products to maintain market share[4].

Key Takeaways

  • The dexamethasone sodium phosphate injection market is projected to reach USD 200.21 million by 2031, growing at a CAGR of 5.8%.
  • Hospitals and clinics are the primary end-users, with hospital pharmacies and retail pharmacies being key distribution channels.
  • The market is driven by the increasing prevalence of chronic diseases and advancements in healthcare infrastructure.
  • Regulatory frameworks and economic factors are significant restraints.
  • Companies are investing heavily in clinical trials and research, with a focus on rare diseases and technological advancements.

FAQs

What is the projected market size of dexamethasone sodium phosphate injections by 2031?

The market size is projected to reach USD 200.21 million by 2031[1].

Which regions are driving the growth of the dexamethasone sodium phosphate market?

North America, Europe, and the Asia-Pacific region are key drivers due to their advanced healthcare infrastructure and growing health expenditures[1].

What are the primary end-user segments for dexamethasone sodium phosphate injections?

The primary end-user segments are hospitals and clinics[1].

How is the distribution of dexamethasone sodium phosphate injections segmented?

The distribution is segmented into hospital pharmacies, retail pharmacies, and online pharmacies[1].

What are the key drivers of the dexamethasone sodium phosphate market?

The key drivers include the increasing prevalence of chronic diseases, advancements in healthcare infrastructure, and a rising emphasis on patient-centric care[1][3].

Sources

  1. Verified Market Research: Dexamethasone Sodium Phosphate Injection Market Size And Forecast[1].
  2. Quince Therapeutics: Quince Therapeutics Provides Business Update and Reports Second Quarter 2024 Financial Results[2].
  3. Market Research Intellect: Global Dexamethasone Sodium Phosphate Preparation Market Size[3].
  4. Cognitive Market Research: Global Dexamethasone Sodium Phosphate Market Report 2024[4].
  5. Quince Therapeutics: Quince Therapeutics Provides Business Update and Reports Fourth Quarter and Fiscal 2023 Financial Results[5].

More… ↓

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