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Last Updated: December 26, 2024

GANTRISIN Drug Patent Profile


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When do Gantrisin patents expire, and when can generic versions of Gantrisin launch?

Gantrisin is a drug marketed by Roche and is included in five NDAs.

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

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Summary for GANTRISIN
US Patents:0
Applicants:1
NDAs:5
Raw Ingredient (Bulk) Api Vendors: 125
Patent Applications: 4,584
DailyMed Link:GANTRISIN at DailyMed
Drug patent expirations by year for GANTRISIN

US Patents and Regulatory Information for GANTRISIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche GANTRISIN sulfisoxazole diolamine INJECTABLE;INJECTION 006917-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche GANTRISIN sulfisoxazole acetyl SYRUP;ORAL 009182-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche GANTRISIN sulfisoxazole diolamine OINTMENT;OPHTHALMIC 008414-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche GANTRISIN sulfisoxazole diolamine SOLUTION/DROPS;OPHTHALMIC 007757-002 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

GANTRISIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gantrisin

Introduction

Gantrisin, a sulfonamide antibiotic available as a pediatric suspension, has been a part of the pharmaceutical market for several decades. To understand its market dynamics and financial trajectory, it is crucial to analyze its usage, market trends, and the broader context of the antibiotic market.

Historical Context and Approval

Gantrisin, containing acetyl sulfisoxazole, was approved and introduced to the market in the 1950s. It has been used to treat various bacterial infections, including urinary tract infections, meningococcal meningitis, and other conditions[2][4].

Market Usage and Indications

Gantrisin is primarily used to treat acute, recurrent, or chronic urinary tract infections, meningococcal meningitis, and as adjunctive therapy for conditions like toxoplasmosis and Haemophilus influenzae meningitis. Its use is limited to pediatric patients over 2 months of age due to contraindications in younger infants and pregnant women at term[2][4].

Competitive Landscape

The antibiotic market is highly competitive, with numerous drugs available for various infections. Gantrisin competes with other sulfonamides and broader-spectrum antibiotics. However, its specific indications and pediatric formulation set it apart in the market. The increasing frequency of antibiotic-resistant organisms has impacted the usefulness of sulfonamides, including Gantrisin, particularly in treating chronic and recurrent urinary tract infections[4].

Regulatory and Safety Considerations

Gantrisin has several contraindications and warnings associated with its use. It is contraindicated in patients with known hypersensitivity to sulfonamides, infants less than 2 months of age, pregnant women at term, and nursing mothers with infants less than 2 months old. Severe reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and blood dyscrasias have been reported, necessitating careful monitoring and discontinuation at the first sign of an adverse reaction[1][2].

Pharmacokinetics and Distribution

The drug's pharmacokinetics, including its rapid absorption, high protein binding, and distribution primarily in the extracellular space, influence its market positioning. It readily crosses the placental and blood-brain barriers, which is crucial for its therapeutic effects but also raises safety concerns[1][4].

Financial Performance

The financial performance of Gantrisin is influenced by several factors, including its market demand, competition, and regulatory environment. Here are some key points:

Sales and Revenue

Historical data indicates that Gantrisin has maintained a steady market presence, although its sales have likely been impacted by the rise of more modern antibiotics and the increasing resistance to sulfonamides. The exact revenue figures are not publicly disclosed, but it is clear that the drug has been a part of the pharmaceutical market for decades.

Pricing and Accessibility

The pricing of Gantrisin can vary by region and is influenced by local healthcare policies and market conditions. In general, sulfonamides are considered relatively affordable compared to newer antibiotics, which can affect their market share and revenue.

Market Trends

The antibiotic market is subject to trends such as the increasing concern over antibiotic resistance, which can reduce the demand for older antibiotics like Gantrisin. However, its specific use in pediatric patients and certain infections ensures it remains a viable option in the market.

Challenges and Opportunities

Challenges

  • Antibiotic Resistance: The growing issue of antibiotic resistance reduces the effectiveness and demand for sulfonamides.
  • Safety Concerns: Severe adverse reactions and contraindications limit its use in certain patient populations.
  • Competition: The presence of newer, broader-spectrum antibiotics competes for market share.

Opportunities

  • Niche Market: Gantrisin's specific indications, particularly in pediatric care, provide a niche market where it remains a preferred option.
  • Adjunctive Therapy: Its use as adjunctive therapy in conditions like toxoplasmosis and Haemophilus influenzae meningitis maintains its relevance.
  • Affordability: Being relatively affordable compared to newer antibiotics can make it a preferred choice in certain healthcare settings.

Future Outlook

The future of Gantrisin in the market will depend on several factors:

Regulatory Updates

Any changes in regulatory guidelines or safety warnings can impact its market position.

Market Demand

Continued demand for affordable and effective antibiotics in pediatric care will sustain its market presence.

Research and Development

While Gantrisin itself may not be the subject of new clinical trials, advancements in antibiotic research could either complement or replace it.

Key Takeaways

  • Historical Significance: Gantrisin has been a part of the pharmaceutical market since the 1950s.
  • Specific Indications: It is used primarily for pediatric patients with specific infections.
  • Regulatory Considerations: Contraindications and safety warnings are critical in its use.
  • Market Trends: The rise of antibiotic resistance and competition from newer antibiotics affect its market share.
  • Financial Performance: Steady but potentially declining due to market trends and competition.

FAQs

What is Gantrisin used for?

Gantrisin is used to treat various bacterial infections, including urinary tract infections, meningococcal meningitis, and as adjunctive therapy for conditions like toxoplasmosis and Haemophilus influenzae meningitis.

Who should not take Gantrisin?

Gantrisin is contraindicated in patients with known hypersensitivity to sulfonamides, infants less than 2 months of age, pregnant women at term, and nursing mothers with infants less than 2 months old.

What are the potential side effects of Gantrisin?

Severe reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and blood dyscrasias have been reported. Other side effects include renal complications, hematologic disorders, and musculoskeletal issues.

How is Gantrisin administered?

Gantrisin is administered orally as a pediatric suspension. The dosage is typically 150 mg/kg/24 hours or 4 gm/M²/24 hours, divided into 4 to 6 doses per day, with a maximum dose not exceeding 6 gm/24 hours.

Is Gantrisin still widely used?

While Gantrisin remains a part of the pharmaceutical market, its use has been impacted by the rise of newer antibiotics and the increasing issue of antibiotic resistance.

Sources

  1. Drugs.com: Gantrisin: Package Insert / Prescribing Information.
  2. RxList: Gantrisin (Acetyl Sulfisoxazole Pediatric Suspension).
  3. DrugBank: Acetyl sulfisoxazole: Uses, Interactions, Mechanism of Action.
  4. CDC: Vital and Health Statistics (not directly relevant but provides context on healthcare statistics).

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