Tobramycin sulfate - Generic Drug Details

What are the generic sources for tobramycin sulfate and what is the scope of patent protection?

Tobramycin sulfate is the generic ingredient in four branded drugs marketed by Lilly, Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Teva Pharms Usa, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for tobramycin sulfate. Eleven suppliers are listed for this compound.

Summary for tobramycin sulfate

US Patents:	0
Tradenames:	4
Applicants:	16
NDAs:	36
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	5
Patent Applications:	6,773
What excipients (inactive ingredients) are in tobramycin sulfate?	tobramycin sulfate excipients list
DailyMed Link:	tobramycin sulfate at DailyMed

Recent Clinical Trials for tobramycin sulfate

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

Sponsor	Phase
Madonna Magdy Fahmy	Early Phase 1
Osteal Therapeutics, Inc.	Phase 2
Joint Purification Systems	Phase 2

See all tobramycin sulfate clinical trials

Pharmacology for tobramycin sulfate

Drug Class

Aminoglycoside Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for tobramycin sulfate

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for tobramycin sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland Pharma Ltd	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	211189-001	May 18, 2021	AP	RX	No	No
Fresenius Kabi Usa	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	065122-002	Nov 29, 2002	AP	RX	No	Yes
Lilly	NEBCIN	tobramycin sulfate	INJECTABLE;INJECTION	050477-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hikma	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063118-001	Jul 29, 1991		DISCN	No	No
Fresenius Kabi Usa	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	065122-001	Nov 29, 2002	AP	RX	No	Yes
Hospira	TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	tobramycin sulfate	INJECTABLE;INJECTION	063081-006	Jun 2, 1993		DISCN	No	No

Tobramycin sulfate Market Analysis and Financial Projection Experimental

Tobramycin Sulfate Market Dynamics and Financial Trajectory

Introduction to Tobramycin Sulfate

Tobramycin sulfate is an aminoglycoside antibiotic widely used for treating various bacterial infections, including those of the eye, respiratory tract, and other body parts. Its efficacy against gram-negative bacteria, particularly Pseudomonas aeruginosa, makes it a crucial component in modern healthcare.

Global Market Size and Forecast

As of 2023, the global tobramycin eye drop market, a significant segment of the broader tobramycin sulfate market, was valued at approximately $12.21 billion. This market is projected to grow to $19.05 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 5.07% between 2024 and 2032[1].

For the specific segment of tobramycin eye drops, another report indicates a market size of $0.76 billion in 2023, expected to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028[2].

Market Drivers

Rising Incidence of Eye Infections

The increasing prevalence of eye infections, such as bacterial keratitis, is a significant driver of the tobramycin eye drops market. As more people are affected by these conditions, the demand for effective treatments like tobramycin eye drops rises[2].

Positive Clinical Trial Outcomes

Positive outcomes from clinical trials have bolstered the confidence of healthcare practitioners and patients in the efficacy of tobramycin eye drops. This has led to increased adoption and prescriptions[2].

Increased Adoption by Ophthalmologists

Ophthalmologists are increasingly recommending tobramycin eye drops due to their proven effectiveness in treating bacterial eye infections. This increased adoption is a key factor in market growth[2].

Expansion into Emerging Markets

The expansion of tobramycin eye drops into emerging economies is another significant driver. As healthcare access improves in these regions, the demand for these eye drops is expected to increase[2].

Regional Dynamics

Asia-Pacific Dominance

The Asia-Pacific region is predicted to maintain its dominant position in the global tobramycin eye drop market. This region contributed about 60% of the global market revenue in 2023 and is expected to continue leading due to the surging acceptance of the product among the geriatric population and people residing in hot climatic conditions[1].

North American Growth

North America is set to register the fastest CAGR over the forecasting timeline, driven by an increase in the production of tobramycin eye drops in countries like the U.S. and a surge in the aging population[1].

Challenges and Restraints

Side Effects

Long-term use of tobramycin eye drops can lead to side effects such as increased risk of antibiotic resistance, allergic reactions, and other adverse effects. These side effects can deter some patients and healthcare providers[2].

Alternative Treatment Options

The development of alternative treatment options for eye infections could potentially reduce the demand for tobramycin eye drops. However, the established efficacy and widespread use of tobramycin are likely to maintain its market position[2].

Production Costs and Raw Material Availability

The adverse impact of the product on the eye, surge in production costs, and scarce availability of raw materials can hinder the expansion of the global tobramycin eye drop industry[1].

Product Segmentation

The global tobramycin eye drop market is segmented into tobramycin ophthalmic suspension, tobramycin & dexamethasone ophthalmic suspension, and other tobramycin combination segments. The tobramycin ophthalmic suspension segment, which acquired nearly 57% of the global market earnings in 2023, is predicted to register the highest gains in the coming years[1].

Application Segmentation

Based on application, the global tobramycin eye drop industry is sectored into adult and children segments. The adult segment, which gathered a lucrative share of the global industry in 2023, is predicted to lead the segmental growth in the coming years due to massive product demand from the adult population[1].

Key Players

The global tobramycin eye drop market is led by players such as Hikma Pharmaceuticals PLC, Grevis Pharmaceuticals Pvt Ltd., Bausch Health Companies Inc., Hilbert Healthcare, Sanify Healthcare, and others. These companies play a crucial role in driving innovation and market growth through their product offerings and strategic initiatives[1].

Financial Projections

• By 2028, the tobramycin eye drops market is expected to reach $1.37 billion, with a CAGR of 12.4% from 2023 to 2028[2].
• Another projection indicates that the market could reach $2.573 billion by 2031, with a CAGR of 14.1% from 2024 to 2031[2].

Clinical Efficacy and Safety

Tobramycin sulfate has been evaluated in numerous clinical studies, showing a satisfactory response in greater than 86% of patients. However, it also comes with potential side effects such as nephrotoxicity, ototoxicity, and neuromuscular blockade, which must be carefully managed[3][5].

"Tobramycin sulfate, a new bactericidal aminoglycoside antibiotic, has been evaluated in 3,506 patients. Its in vitro activity is similar to that of other aminoglycoside antibiotics, except that it is more active against Pseudomonas aeruginosa."[3]

Key Takeaways

• The global tobramycin eye drops market is growing rapidly due to increasing approvals, positive clinical trial outcomes, and rising adoption.
• The market is expected to reach significant values by 2028 and 2032, driven by expansion into emerging markets and advancements in healthcare infrastructure.
• Trends such as telemedicine, eco-friendly practices, combination therapies, and strategic partnerships are shaping the market.
• Despite challenges like side effects and alternative treatments, the market's financial trajectory remains strong.

FAQs

What is the current market size of the tobramycin eye drops market?

The global tobramycin eye drops market was valued at $0.76 billion in 2023 and is projected to grow to $0.86 billion in 2024[2].

What are the key drivers of the tobramycin eye drops market?

Key drivers include the rising incidence of eye infections, positive clinical trial outcomes, increased adoption by ophthalmologists, and expansion into emerging markets[2].

Which region is expected to be the fastest-growing in the tobramycin eye drops market?

The Asia-Pacific region is expected to be the fastest-growing during the forecast period due to improving healthcare infrastructure and increasing awareness of eye health[2].

What are some of the challenges facing the tobramycin eye drops market?

Challenges include side effects associated with long-term use and the development of alternative treatment options[2].

What is the projected market size of the tobramycin eye drops market by 2028?

The market is anticipated to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028[2].

Sources

1. Zion Market Research: Tobramycin Eye Drop Market Size, Share, Analysis, Growth.
2. Drug Patent Watch: Generic TOBRAMYCIN INN entry, pharmaceutical patent expiry and more.
3. PubMed: Tobramycin sulfate: a summary of worldwide experience.
4. Southeast News Channel Nebraska: Tobramycin Sulfate Injection Market 2024: Research by Size, Advanced Competitive Landscape and Revenue Forecasts by 2032.
5. FDA: TOBRAMYCIN for Injection.