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Last Updated: December 27, 2024

LIPO GANTRISIN Drug Patent Profile


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Which patents cover Lipo Gantrisin, and what generic alternatives are available?

Lipo Gantrisin is a drug marketed by Roche and is included in one NDA.

The generic ingredient in LIPO GANTRISIN is sulfisoxazole acetyl. There are three drug master file entries for this compound. Additional details are available on the sulfisoxazole acetyl profile page.

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Summary for LIPO GANTRISIN
Drug patent expirations by year for LIPO GANTRISIN

US Patents and Regulatory Information for LIPO GANTRISIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche LIPO GANTRISIN sulfisoxazole acetyl EMULSION;ORAL 009182-009 Approved Prior to Jan 1, 1982 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

LIPO GANTRISIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LIPO GANTRISIN: A Comprehensive Analysis

Introduction to LIPO GANTRISIN

While the term "LIPO GANTRISIN" is not directly associated with any specific drug in the provided sources, we can infer that it might involve a combination or modification of existing drugs, such as Gantrisin (acetyl sulfisoxazole pediatric suspension), and Lipocine's proprietary technologies. Here, we will analyze the market dynamics and financial trajectory based on the components and related industries.

Understanding Gantrisin

Gantrisin is a sulfonamide antibiotic used primarily to treat urinary tract infections and other bacterial infections. It is available as a pediatric suspension and has specific dosing and contraindications, particularly for infants under 2 months and pregnant women[1].

Lipocine's Role in Drug Development

Lipocine is a biopharmaceutical company focused on developing differentiated products with effective oral delivery systems. They have several drug candidates in development, targeting large addressable markets with significant unmet medical needs, particularly in CNS disorders and other therapeutic areas[5].

Market Opportunity

Current Market Landscape

The pharmaceutical market, especially for antibiotics and specialized therapeutics, is vast and growing. For instance, the market for GLP-1s (glucagon-like peptide-1) treatments, which are not directly related to Gantrisin but illustrate the scale, is estimated to be between $100 billion to $150 billion annually in the U.S. alone by 2030[3].

Potential for LIPO GANTRISIN

If LIPO GANTRISIN involves integrating Lipocine's oral delivery technology with the antibacterial properties of Gantrisin, it could potentially address unmet needs in the antibiotic market. This could include improving the bioavailability, reducing side effects, or enhancing the efficacy of sulfonamide antibiotics.

Financial Trajectory

Lipocine's Financial Performance

Lipocine has shown significant financial movements in recent quarters. For the second quarter of 2024, they reported a net loss of $3.1 million, but for the six months ended June 30, 2024, they reported a net profit of $0.5 million. This shift is largely due to licensing revenue and cost management[2].

Revenue Streams

  • Licensing Revenue: Lipocine has generated substantial revenue from licensing agreements, such as the Verity License Agreement, which contributed $7.6 million in the first quarter of 2024[5].
  • Research and Development: Despite decreases in some R&D expenses, there are ongoing costs related to clinical studies, such as those for LPCN 1154, which could impact the financial trajectory of any new drug development[2][5].

Cash and Investment Position

As of March 31, 2024, Lipocine had $24.6 million in unrestricted cash, cash equivalents, and marketable investment securities. This financial position provides a solid foundation for further research and development activities[5].

Market Dynamics

Competitive Landscape

The antibiotic market is highly competitive, with established players and continuous innovation. Integrating Lipocine's technology with Gantrisin would need to offer significant advantages to compete effectively.

Regulatory Considerations

Any new formulation or modification of Gantrisin would need to undergo rigorous clinical trials and regulatory approvals. This process is costly and time-consuming but crucial for market entry[1].

Patient and Market Demand

There is a constant demand for effective and safe antibiotics. If LIPO GANTRISIN can offer improved efficacy, reduced side effects, or better patient compliance, it could capture a significant market share.

Key Challenges

Development Costs

Developing a new drug or formulation is expensive. Lipocine's financial reports show significant R&D expenses, which would need to be managed carefully to ensure profitability[2][5].

Regulatory Risks

Regulatory approvals are never guaranteed, and any setbacks could significantly impact the financial trajectory and market dynamics of LIPO GANTRISIN.

Market Competition

The pharmaceutical market is highly competitive, and new entrants must differentiate themselves through innovation, pricing, or marketing strategies.

Future Outlook

Growth Potential

If successful, LIPO GANTRISIN could tap into a large market, especially if it addresses unmet needs in antibiotic therapy. The integration of Lipocine's oral delivery technology could enhance patient compliance and efficacy, leading to significant market growth.

Strategic Partnerships

Collaborations with other pharmaceutical companies, like Eli Lilly or Novo Nordisk, which are leaders in their respective fields, could accelerate market penetration and financial growth[3].

Key Takeaways

  • Market Opportunity: The potential market for LIPO GANTRISIN is significant, given the demand for effective antibiotics and the growing pharmaceutical market.
  • Financial Trajectory: Lipocine's financial performance indicates a potential for profitability, especially with licensing revenue and managed R&D costs.
  • Regulatory and Development Challenges: Any new drug formulation must navigate regulatory approvals and manage development costs carefully.
  • Competitive Landscape: Differentiation through innovation and strategic partnerships will be crucial for market success.

FAQs

Q: What is Gantrisin used for?

Gantrisin (acetyl sulfisoxazole pediatric suspension) is used to treat or prevent various types of infections, including urinary tract infections and meningococcal meningitis[1].

Q: What is Lipocine's focus in drug development?

Lipocine focuses on developing differentiated products with effective oral delivery systems, targeting large addressable markets with significant unmet medical needs[5].

Q: How significant is the market opportunity for new antibiotic formulations?

The market opportunity is substantial, with the potential to tap into a multi-billion dollar market, especially if the new formulation addresses unmet needs in antibiotic therapy[3].

Q: What are the key financial challenges for developing LIPO GANTRISIN?

The key financial challenges include managing R&D expenses, securing licensing revenue, and navigating regulatory approvals[2][5].

Q: How can LIPO GANTRISIN differentiate itself in the market?

LIPO GANTRISIN can differentiate itself through improved efficacy, reduced side effects, better patient compliance, and strategic partnerships with other pharmaceutical companies[3].

Sources

  1. RxList: Gantrisin (Acetyl Sulfisoxazole Pediatric Suspension) - RxList
  2. PR Newswire: Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2024
  3. Baron Capital Group: A Multi-Billion-Dollar Drug Market
  4. ACS Publications: Impact of Drug Physicochemical Properties on Lipolysis-Triggered Supersaturation and Precipitation
  5. PR Newswire: Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024

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