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Last Updated: December 22, 2024

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE - Generic Drug Details


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What are the generic sources for dexamethasone sodium phosphate; neomycin sulfate and what is the scope of patent protection?

Dexamethasone sodium phosphate; neomycin sulfate is the generic ingredient in three branded drugs marketed by Merck, Bausch And Lomb, Alcon Pharms Ltd, and Pharmafair, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
US Patents:0
Tradenames:3
Applicants:4
NDAs:5
Clinical Trials: 1
DailyMed Link:DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE at DailyMed
Recent Clinical Trials for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

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

SponsorPhase
Huro Biotech Joint Stock CompanyN/A
Vietstar Biomedical ResearchN/A

See all DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
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
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05CA Antiinfectives
B05C IRRIGATING SOLUTIONS
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
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
D06AX Other antibiotics for topical use
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
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
J01GB Other aminoglycosides
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R02AB Antibiotics
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
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
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
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; NEOMYCIN SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Pharms Ltd NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate; neomycin sulfate SOLUTION/DROPS;OPHTHALMIC 062714-001 Jul 21, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmafair NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate; neomycin sulfate SOLUTION/DROPS;OPHTHALMIC 062539-001 Jan 10, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck NEODECADRON dexamethasone sodium phosphate; neomycin sulfate OINTMENT;OPHTHALMIC 050324-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate; neomycin sulfate SOLUTION/DROPS;OPHTHALMIC 064055-001 Oct 30, 1995 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; NEOMYCIN SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexamethasone Sodium Phosphate and Neomycin Sulfate

Introduction

Dexamethasone sodium phosphate and neomycin sulfate are key components in various ophthalmic and otic formulations, particularly in combination products like eye drops and ear drops. These medications are crucial for treating infections and inflammation in the eyes and ears. Here, we delve into the market dynamics and financial trajectory of these drugs.

Therapeutic Uses and Mechanism

Dexamethasone sodium phosphate is a corticosteroid that reduces inflammation and immune responses, while neomycin sulfate is an aminoglycoside antibiotic effective against both gram-positive and gram-negative bacteria. Together, they are used to treat conditions such as allergic reactions, uveitis, iritis, and bacterial infections in the eyes and ears[1][2].

Market Size and Growth

The global market for ophthalmic drug delivery devices, which includes formulations containing dexamethasone sodium phosphate and neomycin sulfate, is projected to grow significantly. By 2031, the market is expected to reach USD 577.33 million, growing at a CAGR of 6.17% from 2023 to 2031. The eye drops segment, which dominates this market, is anticipated to exhibit a CAGR of 4.92% during the same period[3].

Regional Market Dynamics

North America is the largest market shareholder for ophthalmic drug delivery devices, driven by the increasing prevalence of ocular disorders such as glaucoma, age-related macular degeneration (AMD), and cataracts. Europe is expected to be the fastest-growing market, driven by technological advancements and the integration of digital solutions in ophthalmic drug delivery[3].

Dexamethasone Sodium Phosphate Preparation Market

The Dexamethasone Sodium Phosphate Preparation Market has seen rapid growth and is expected to continue expanding from 2023 to 2031. This market is segmented by type (oral, external use, intravenous infusion) and application (hospitals, clinics, others), with significant growth anticipated across various geographical regions[4].

Key Drivers

  • Increasing Prevalence of Ocular Disorders: The growing prevalence of ocular diseases such as glaucoma, AMD, and cataracts is a major driver for the demand of ophthalmic drugs and drug-delivery devices[3].
  • Technological Advancements: Nanotechnology and other advancements in drug delivery systems are enhancing the efficacy and patient tolerance of ophthalmic medications, including those containing dexamethasone sodium phosphate and neomycin sulfate[3].
  • Ease of Use and Manufacturing: Eye drops, which are a common formulation for these drugs, are preferred due to their ease of bulk manufacturing and higher patient tolerance[3].

Challenges and Restraints

  • Technological Competition: While eye drops are dominant, other formulations such as liquid sprays and more advanced drug delivery systems may compete and potentially limit the growth of traditional eye drops[3].
  • Usage Difficulties: Geriatric patients may face difficulties in using eye drops, which could impact market growth[3].
  • Regulatory and Safety Considerations: The use of dexamethasone and neomycin requires careful consideration of potential side effects and contraindications, such as viral or fungal infections and certain eye conditions like cataracts or glaucoma[1].

Financial Projections

The financial trajectory for dexamethasone sodium phosphate and neomycin sulfate is positive, with the market expected to see sustained growth. The Dexamethasone Sodium Phosphate Preparation Market is projected to experience robust growth rates throughout the forecast period from 2023 to 2031, driven by increasing demand and technological advancements[4].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of formulations containing dexamethasone phosphate and neomycin sulfate. For example, a study comparing polymyxin sulfate/neomycin sulfate with and without dexamethasone phosphate in treating acute bacterial otitis externa showed that the addition of dexamethasone significantly reduced swelling and improved patient ratings of treatment efficacy[2].

Regulatory Standards

These medications must meet stringent regulatory standards. For instance, the United States Pharmacopeial Convention (USP) sets specific criteria for the composition and purity of neomycin sulfate and dexamethasone sodium phosphate solutions, ensuring their safety and efficacy[5].

Conclusion

The market for dexamethasone sodium phosphate and neomycin sulfate is driven by the increasing need for effective treatments for ocular and otic infections and inflammation. With technological advancements, growing prevalence of ocular disorders, and strong regulatory frameworks, this market is poised for significant growth.

Key Takeaways

  • The global ophthalmic drug delivery devices market, including eye drops with dexamethasone sodium phosphate and neomycin sulfate, is expected to reach USD 577.33 million by 2031.
  • North America is the largest market shareholder, with Europe being the fastest-growing region.
  • Technological advancements and increasing prevalence of ocular disorders are key drivers.
  • The Dexamethasone Sodium Phosphate Preparation Market is expected to see robust growth from 2023 to 2031.
  • Clinical efficacy and safety have been demonstrated in various studies.

FAQs

Q: What are the primary therapeutic uses of dexamethasone sodium phosphate and neomycin sulfate? A: These drugs are used to treat infections and inflammation in the eyes and ears, including conditions like allergic reactions, uveitis, iritis, and bacterial infections.

Q: What is the projected growth rate of the ophthalmic drug delivery devices market? A: The market is expected to grow at a CAGR of 6.17% from 2023 to 2031.

Q: Which region dominates the ophthalmic drug delivery devices market? A: North America is the largest market shareholder, driven by the increasing prevalence of ocular disorders.

Q: What are the key drivers for the growth of the Dexamethasone Sodium Phosphate Preparation Market? A: The increasing prevalence of ocular disorders and technological advancements in drug delivery systems are major drivers.

Q: Are there any challenges associated with the use of dexamethasone sodium phosphate and neomycin sulfate? A: Yes, challenges include potential side effects, contraindications for certain eye conditions, and difficulties in usage, especially among geriatric patients.

Sources

  1. AdvaCare Pharma - Dexamethasone + Neomycin Eye Drops.
  2. PubMed - Dexamethasone phosphate in antibiotic ear drops for the treatment of acute bacterial otitis externa.
  3. Straits Research - Ophthalmic Drug Delivery Devices Market Size & Demand | 2031.
  4. Market Research Intellect - Global Dexamethasone Sodium Phosphate Preparation Market Size.
  5. USP - Neomycin Sulfate and Dexamethasone Sodium Phosphate solution.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.