You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for fluocinolone acetonide; neomycin sulfate and what is the scope of patent protection?

Fluocinolone acetonide; neomycin sulfate is the generic ingredient in one branded drug marketed by Medimetriks Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE
Recent Clinical Trials for FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE

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

SponsorPhase
Noah Rosenberg, MDPhase 4

See all FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE clinical trials

Pharmacology for FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
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
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
D07AC Corticosteroids, potent (group III)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
J01GB Other aminoglycosides
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
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
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

US Patents and Regulatory Information for FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medimetriks Pharms NEO-SYNALAR fluocinolone acetonide; neomycin sulfate CREAM;TOPICAL 060700-001 Approved Prior to Jan 1, 1982 RX No Yes ⤷  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

FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluocinolone Acetonide and Neomycin Sulfate

Introduction to Fluocinolone Acetonide and Neomycin Sulfate

Fluocinolone acetonide and neomycin sulfate are two distinct pharmaceutical compounds with various medical applications. Fluocinolone acetonide is a synthetic corticosteroid, while neomycin sulfate is an aminoglycoside antibiotic. Understanding their market dynamics and financial trajectories is crucial for investors, pharmaceutical companies, and healthcare professionals.

Fluocinolone Acetonide Market Dynamics

Medical Applications

Fluocinolone acetonide is widely used in dermatology for the relief of inflammatory dermatosis, dermatitis, psoriasis, and other skin conditions. It is also used in ophthalmic preparations, particularly as an intravitreal implant for treating non-infectious uveitis affecting the posterior segment of the eye and diabetic macular edema[3].

Market Size and Growth

The market for fluocinolone acetonide, particularly in its ophthalmic form, has seen significant growth. The intravitreal implant, such as the one developed by Bausch & Lomb, has completed pivotal trials and has been FDA-approved for specific indications. This approval has contributed to the market's expansion. The sustained release mechanism of the implant, providing therapy for up to 3 years, is a key factor in its market appeal[2].

Regional Market

The regional distribution of fluocinolone acetonide's market is influenced by regulatory approvals and healthcare infrastructure. In the United States, the FDA approval in 2018 for the treatment of chronic non-infectious uveitis has boosted its market presence. Similar approvals in other regions, such as Europe and Asia, have also contributed to its global market growth[3].

Competitive Landscape

The competitive landscape for fluocinolone acetonide includes other corticosteroids and ophthalmic treatments. However, its unique delivery mechanism and specific indications give it a competitive edge. Companies like Bausch & Lomb and Taro Pharmaceuticals are key players in this market, investing heavily in research and development to expand the drug's applications[2][3].

Neomycin Sulfate Market Dynamics

Medical Applications

Neomycin sulfate is an antibiotic used in various pharmaceutical formulations, including topical creams, ointments, and ophthalmic solutions. It is often combined with corticosteroids like fluocinolone acetonide in products such as NEO-SYNALAR cream for treating skin infections and inflammatory conditions[5].

Market Size and Growth

The global market for neomycin sulfate is substantial, driven by its widespread use in over-the-counter (OTC) and prescription medications. However, the market size is influenced by regional regulations and sensitization rates. For instance, in regions where neomycin is less freely available, such as Europe and Canada, the market size is smaller compared to the United States[4].

Sensitization and Regulatory Impact

Sensitization to neomycin is a significant concern, affecting around 6% of the population in some studies. This has led to regulatory changes in some regions, limiting its availability to prescription-only. Such regulations can impact the market size and growth trajectory of neomycin sulfate products[4].

Regional Market

North America, particularly the United States, is a leading consumer of neomycin sulfate due to its widespread availability in OTC formulations. However, in regions like Europe and Canada, where it is less freely available, the market is smaller. Brazil also has a significant market for neomycin sulfate, although the sensitization rate is a concern[1][4].

Financial Trajectory

Revenue and Growth Projections

The financial trajectory for both drugs is influenced by their market dynamics. For fluocinolone acetonide, the approval for ophthalmic indications and the unique delivery mechanism of its intravitreal implant have driven revenue growth. The market is expected to continue growing as more patients are treated with this innovative therapy.

For neomycin sulfate, the revenue is more stable but can be affected by regulatory changes and sensitization rates. The combination products like NEO-SYNALAR cream contribute significantly to its revenue, but the market growth may be slower due to these factors[2][5].

Key Players and Investments

Companies like Bausch & Lomb and Taro Pharmaceuticals are investing heavily in the development and marketing of fluocinolone acetonide products. These investments are expected to yield significant returns as the market expands. For neomycin sulfate, companies focus on maintaining market share through a combination of OTC and prescription products, while also addressing sensitization concerns through research and development[2][3].

Challenges and Opportunities

Regulatory Challenges

Both drugs face regulatory challenges. For fluocinolone acetonide, the focus is on expanding approvals for new indications, while for neomycin sulfate, it is about managing sensitization rates and complying with regional regulations.

Market Expansion Opportunities

The ophthalmic market for fluocinolone acetonide offers significant expansion opportunities, particularly in regions where the drug has not yet been approved. For neomycin sulfate, opportunities lie in developing combination products that minimize sensitization risks while maintaining therapeutic efficacy.

Technological Advancements

Advancements in drug delivery technologies, such as the intravitreal implant for fluocinolone acetonide, present opportunities for market growth. Similarly, developing formulations that reduce the risk of sensitization to neomycin sulfate could enhance its market position.

Conclusion

The market dynamics and financial trajectories of fluocinolone acetonide and neomycin sulfate are shaped by their medical applications, regulatory environments, and technological advancements. Fluocinolone acetonide's innovative delivery mechanisms and expanding ophthalmic indications drive its growth, while neomycin sulfate's market is influenced by its widespread use and regulatory challenges.

Key Takeaways

  • Fluocinolone Acetonide: Strong growth driven by ophthalmic indications and innovative delivery mechanisms.
  • Neomycin Sulfate: Stable revenue but influenced by sensitization rates and regional regulations.
  • Regulatory Impact: Approvals and regulations significantly affect market size and growth.
  • Technological Advancements: Key to market expansion and addressing sensitization concerns.
  • Combination Products: NEO-SYNALAR cream and similar products contribute to revenue but face sensitization challenges.

FAQs

Q1: What are the primary medical applications of fluocinolone acetonide?

Fluocinolone acetonide is primarily used in dermatology for inflammatory dermatosis, dermatitis, and psoriasis, and in ophthalmology for treating non-infectious uveitis and diabetic macular edema.

Q2: How does the intravitreal implant of fluocinolone acetonide work?

The intravitreal implant delivers fluocinolone acetonide directly to the posterior segment of the eye, providing sustained therapy for up to 3 years.

Q3: What is the impact of sensitization on the neomycin sulfate market?

Sensitization to neomycin sulfate affects around 6% of the population, leading to regulatory restrictions in some regions and impacting market size and growth.

Q4: Which regions are the leading consumers of neomycin sulfate?

North America, particularly the United States, is a leading consumer of neomycin sulfate due to its widespread availability in OTC formulations.

Q5: How do combination products like NEO-SYNALAR cream contribute to the market?

Combination products like NEO-SYNALAR cream, which combine neomycin sulfate with fluocinolone acetonide, contribute significantly to revenue but face challenges related to neomycin sensitization.

Sources

  1. Neomycin Sulphate Market Size, Share, Growth & Forecast - ChemAnalyst
  2. Fluocinolone Acetonide Implant - Science.gov
  3. Fluocinolone Acetonide: Uses, Interactions, Mechanism of Action - DrugBank
  4. Neomycin: Sources of Contact and Sensitization Evaluation - SciELO
  5. NEO-SYNALAR - Neomycin Sulfate and Fluocinolone Acetonide Cream - DailyMed

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

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.