TOBRAMYCIN Drug Patent Profile

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

Tobramycin is a drug marketed by Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb, Chartwell Rx, Gland Pharma Ltd, Somerset Theraps Llc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Hikma, Luoxin Aurovitas, Lupin, Mankind Pharma, Micro Labs, Norvium Bioscience, Sun Pharm, Teva Pharms Usa, Amneal, Padagis Us, Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms. and is included in fifty-five NDAs.

The generic ingredient in TOBRAMYCIN is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tobramycin

A generic version of TOBRAMYCIN was approved as tobramycin sulfate by HIKMA on April 26^th, 1991.

Summary for TOBRAMYCIN

US Patents:	0
Applicants:	32
NDAs:	55
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	124
Patent Applications:	2,106
Drug Prices:	Drug price information for TOBRAMYCIN
Drug Sales Revenues:	Drug sales revenues for TOBRAMYCIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TOBRAMYCIN
What excipients (inactive ingredients) are in TOBRAMYCIN?	TOBRAMYCIN excipients list
DailyMed Link:	TOBRAMYCIN at DailyMed

See drug prices for TOBRAMYCIN

See drug sales revenues for TOBRAMYCIN

Recent Clinical Trials for TOBRAMYCIN

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

Sponsor	Phase
Clarametyx Biosciences, Inc.	Phase 1/Phase 2
Shanghai Pulmonary Hospital, Shanghai, China	Phase 4
University of Utah	Early Phase 1

See all TOBRAMYCIN clinical trials

Pharmacology for TOBRAMYCIN

Drug Class

Aminoglycoside Antibacterial

Medical Subject Heading (MeSH) Categories for TOBRAMYCIN

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for TOBRAMYCIN

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

Paragraph IV (Patent) Challenges for TOBRAMYCIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BETHKIS	Inhalation Solution	tobramycin	300 mg/4 mL	201820	1	2017-08-31
TOBI	Inhalation Solution	tobramycin	300 mg/5 mL	050753	1	2009-06-29

US Patents and Regulatory Information for TOBRAMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063080-001	Apr 30, 1991		DISCN	No	No
Fresenius Kabi Usa	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	065122-002	Nov 29, 2002	AP	RX	No	Yes
Mylan Labs Ltd	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	065407-001	Mar 11, 2008	AP	RX	No	No
Hospira	TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	tobramycin sulfate	INJECTABLE;INJECTION	063081-006	Jun 2, 1993		DISCN	No	No
Igi Labs Inc	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063119-001	Oct 31, 1994		DISCN	No	No

EU/EMA Drug Approvals for TOBRAMYCIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Healthcare Limited	Tobi Podhaler	tobramycin	EMEA/H/C/002155 Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2011-07-20
Pari Pharma GmbH	Vantobra (previously Tobramycin PARI)	tobramycin	EMEA/H/C/005086 Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2019-02-18
Pari Pharma GmbH	Vantobra	tobramycin	EMEA/H/C/002633 Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Withdrawn	no	no	no	2015-03-18

TOBRAMYCIN Market Analysis and Financial Projection Experimental

Tobramycin Eye Drops Market Dynamics and Financial Trajectory

Market Overview

The global tobramycin eye drops market is experiencing significant growth, driven by several key factors. Tobramycin, an aminoglycoside antibiotic, is widely used to treat bacterial eye infections, and its market is expanding rapidly.

Current Market Size and Growth

As of 2023, the global tobramycin eye drops market was valued at $0.76 billion. It is projected to grow to $0.86 billion in 2024, representing a compound annual growth rate (CAGR) of 12.3%[1][3].

Future Growth Projections

By 2028, the market is anticipated to reach $1.37 billion, maintaining a CAGR of 12.4%. This robust growth is expected due to the expansion of tobramycin eye drops into emerging markets, advancements in healthcare infrastructure, and ongoing research efforts to enhance product formulations[1][3].

Regional Dynamics

North America dominated the tobramycin eye drop market in 2023, but the Asia-Pacific region is expected to be the fastest-growing during the forecast period. This growth in Asia-Pacific can be attributed to improving healthcare infrastructure and increasing awareness of eye health[1].

Market Drivers

Several factors are driving the growth of the tobramycin eye drops market:

Rising Incidence of Eye Infections

The increasing prevalence of eye infections, including bacterial keratitis, is a significant driver. As more people are affected by these conditions, the demand for effective treatments like tobramycin eye drops rises[4].

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[1][3].

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[1][3].

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[1][3].

Market Trends

Several trends are shaping the tobramycin eye drops market:

Telemedicine and Remote Consultations

The rise of telemedicine and remote consultation services is making it easier for patients to access healthcare, including prescriptions for tobramycin eye drops. This trend is expected to continue and support market growth[3].

Eco-Friendly Packaging and Manufacturing

There is a growing focus on eco-friendly packaging and manufacturing practices in the pharmaceutical industry. This trend may influence product choices in the tobramycin eye drops market as consumers become more environmentally conscious[3].

Combination Therapies

The development of combination therapies that combine tobramycin with other antimicrobial or anti-inflammatory agents is another trend. These combination therapies aim to enhance treatment efficacy and patient outcomes[3].

Strategic Partnerships

Strategic partnerships among pharmaceutical firms are becoming more common, driving innovation and market expansion in the tobramycin eye drops sector[3].

Challenges and Restraints

Despite the positive growth trajectory, the market faces some challenges:

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[4].

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[4].

Financial Projections

The financial outlook for the tobramycin eye drops market is promising:

• By 2028, the market is expected to reach $1.37 billion, with a CAGR of 12.4% from 2023 to 2028[1][3].
• Another projection indicates that the market could reach $2.573 billion by 2031, with a CAGR of 14.1% from 2024 to 2031[4].

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 $1.37 billion by 2028, 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[1][3].

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[1][3][4].

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[1].

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[4].

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[1][3].

Sources

1. EIN Presswire: Tobramycin Eye Drops Market Segments, Drivers, Restraints, And Trends For 2024-2033.
2. Synapse by Patsnap: Dexamethasone/Tobramycin - Drug Targets, Indications, Patents.
3. GII Research: Tobramycin Eye Drop Global Market Report 2024.
4. Coherent Market Insights: Global Tobramycin Eye Drop Market Size and Trends.