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Last Updated: December 22, 2024

GENTAMICIN SULFATE Drug Patent Profile


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Which patents cover Gentamicin Sulfate, and when can generic versions of Gentamicin Sulfate launch?

Gentamicin Sulfate is a drug marketed by Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Padagis Us, Pharmaderm, Taro, Abbott, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, Wyeth Ayerst, Fera Pharms Llc, Sciegen Pharms Inc, Encube, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Paco, Sandoz, B Braun, and Baxter Hlthcare. and is included in forty NDAs.

The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gentamicin Sulfate

A generic version of GENTAMICIN SULFATE was approved as gentamicin sulfate by SANDOZ on December 31st, 1969.

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Drug patent expirations by year for GENTAMICIN SULFATE
Drug Sales Revenue Trends for GENTAMICIN SULFATE

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Recent Clinical Trials for GENTAMICIN SULFATE

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

SponsorPhase
Oslo University HospitalPhase 1/Phase 2
University of California, San DiegoPhase 2
Kaiser PermanentePhase 2

See all GENTAMICIN SULFATE clinical trials

Pharmacology for GENTAMICIN SULFATE

US Patents and Regulatory Information for GENTAMICIN SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062373-003 Sep 7, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cosette GENTAMICIN SULFATE gentamicin sulfate OINTMENT;TOPICAL 064054-001 Apr 29, 1994 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Parenteral GENTAMICIN SULFATE gentamicin sulfate INJECTABLE;INJECTION 063149-001 Nov 21, 1991 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062588-005 Jan 6, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc GENTAMICIN SULFATE gentamicin sulfate SOLUTION/DROPS;OPHTHALMIC 062635-001 Jan 8, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER gentamicin sulfate INJECTABLE;INJECTION 062814-008 Aug 28, 1987 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

GENTAMICIN SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gentamicin Sulfate

Introduction to Gentamicin Sulfate

Gentamicin sulfate is a widely used antibiotic belonging to the aminoglycoside class, effective against a broad spectrum of gram-negative and some gram-positive bacteria. It is utilized in various medical applications, including injections, eye drops, and sustained-release formulations.

Current Market Trends

Increasing Demand

The global gentamicin sulfate market has been experiencing an upswing trend, driven by consistent increases in end-user demand from the downstream sector. This surge is particularly notable in regions such as Europe, where countries like Germany have seen moderate increases in inquiries since January 2023[1].

Geographical Market Dynamics

  • Europe: The European market, especially in Germany, has shown a significant rise in demand. This is partly due to an increase in domestic consumption rates, reflected in the Consumer Price Index (CPI) which climbed from 114.30 to 115.20 points in February 2023[1].
  • United States: The U.S. market also follows a similar trend, with demand influenced by environmental conditions and the spread of antibiotic-resistant infections[1].
  • Asia-Pacific: China has witnessed a significant demand for gentamicin sulfate, both domestically and internationally. Production activities have resumed to meet the increasing demand, leading to a 2% price appreciation in February 2023[1].

Market Segmentation and Applications

Types of Gentamicin Sulfate

The market is segmented based on the purity of gentamicin sulfate, including 99%, 98%, and 95% purity types. Each type has different applications and market dynamics[4].

Applications

Gentamicin sulfate is used in various forms:

  • Gentamicin Sulfate Injection: Commonly used for parenteral administration, particularly effective in treating severe infections such as sepsis, meningitis, and pneumonia[2][5].
  • Gentamicin Sulfate Eye Drops: Used for ocular infections.
  • Gentamicin Sulfate Tablets and Granules: For oral administration.
  • Antibiotic-Loaded Bone Cement: This application is gaining traction, especially in orthopedic surgeries to prevent infections in knee and hip replacements[3].

Financial Trajectory

Market Size and Growth Projections

The global gentamicin sulfate market is anticipated to experience robust growth from 2023 to 2031. The market size is projected to expand significantly, driven by increasing demand and advancements in medical applications. The market is expected to grow at a steady rate, with the global market size valued in USD millions across various segments[4].

Pricing and Supply Dynamics

The prices of gentamicin sulfate have seen fluctuations based on demand and supply. In February 2023, prices rose by 2% due to increased demand, but a stable decrease in demand is expected to reduce prices by 1% in the forthcoming months[1].

Regional Market Performance

  • North America: The U.S. is expected to remain a lucrative market due to advanced bone grafting procedures and a favorable reimbursement landscape[3].
  • Europe: Countries like Germany, the UK, France, Italy, and others are anticipated to witness sound growth prospects[3].
  • Asia-Pacific: China, India, and Japan are expected to see maximum growth due to increasing access to healthcare facilities and enhancing healthcare infrastructure[3].

Drivers and Restraints

Drivers

  • Increasing Prevalence of Infections: The rise in antibiotic-resistant infections and the need for effective treatments drive the demand for gentamicin sulfate[1][2].
  • Advancements in Medical Applications: The use of gentamicin sulfate in antibiotic-loaded bone cement and other orthopedic applications is a significant driver[3].
  • Growing Elderly Population: The increasing number of elderly individuals undergoing surgeries like knee and hip replacements fuels the demand for gentamicin sulfate[3].

Restraints

  • Side Effects and Toxicity: Gentamicin sulfate can cause nephrotoxicity and neurotoxicity, especially in patients with renal impairment or those receiving high doses or prolonged therapy. This can limit its use in certain cases[2].
  • Regulatory and Quality Standards: The need to meet pharmacopeial specifications and regulatory requirements can be a restraint, especially for manufacturers[5].

Competitive Landscape

The gentamicin sulfate market includes several key players such as Fresenius Kabi, Hospira, and other pharmaceutical companies. These players are investing in research and development to offer more efficient products and are involved in mergers and acquisitions to strengthen their market position[4][5].

Product Advancements and Launches

Market players are focusing on product advancements, such as the development of antibiotic-loaded bone cement, which is gaining traction in orthopedic surgeries. The mix of vancomycin and ciprofloxacin is also anticipated to gain market share due to its stronger release profile compared to hydrochloride ciprofloxacin alone[3].

Conclusion

The gentamicin sulfate market is poised for significant growth driven by increasing demand, advancements in medical applications, and a growing elderly population. However, the market must navigate challenges such as side effects, regulatory standards, and competitive dynamics.

Key Takeaways

  • Increasing Demand: Driven by end-user demand and environmental factors.
  • Geographical Growth: Europe, the U.S., and Asia-Pacific regions are key markets.
  • Market Segmentation: Based on purity and applications such as injections, eye drops, and antibiotic-loaded bone cement.
  • Financial Projections: Robust growth from 2023 to 2031.
  • Drivers and Restraints: Increasing infections, medical advancements, and side effects are key factors.
  • Competitive Landscape: Includes major pharmaceutical companies with a focus on R&D and mergers.

FAQs

Q1: What are the primary applications of gentamicin sulfate? Gentamicin sulfate is used in various forms, including injections for parenteral administration, eye drops for ocular infections, and antibiotic-loaded bone cement for orthopedic surgeries.

Q2: Which regions are expected to see significant growth in the gentamicin sulfate market? The U.S., Europe (especially Germany), and Asia-Pacific regions (including China, India, and Japan) are anticipated to witness significant growth.

Q3: What are the potential side effects of gentamicin sulfate? Gentamicin sulfate can cause nephrotoxicity and neurotoxicity, particularly in patients with renal impairment or those receiving high doses or prolonged therapy.

Q4: How does the pricing of gentamicin sulfate fluctuate? Prices fluctuate based on demand and supply. For example, in February 2023, prices rose by 2% due to increased demand but are expected to reduce by 1% in forthcoming months.

Q5: What are the key drivers of the gentamicin sulfate market? The key drivers include the increasing prevalence of antibiotic-resistant infections, advancements in medical applications, and the growing elderly population undergoing surgeries.

Sources

  1. ChemAnalyst: "Gentamicin Sulphate Market Follows an Upswing Trend Across the Globe"[1]
  2. Drugs.com: "Gentamicin Sulfate: Package Insert / Prescribing Info"[2]
  3. Fact.MR: "Antibiotic-loaded Bone Cement Demand Spurred by Incessant Research and Development"[3]
  4. Market Research Intellect: "Global Gentamycin Sulfate Market Size, Trends and Projections"[4]
  5. Global Health Supply Chain: "GENTAMICIN"[5]

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