Tobramycin - Generic Drug Details

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

Tobramycin is the generic ingredient in eleven branded drugs marketed by Novartis, Viatris, Epic Pharma Llc, Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb, Chartwell Rx, Gland, Somerset Theraps Llc, Sandoz, Chiesi, Pulmoflow Inc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Hikma, Luoxin Aurovitas, Lupin, Mankind Pharma, Micro Labs, Norvium Bioscience, Sun Pharm, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, 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 sixty-four NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tobramycin has sixty-one patent family members in twenty-seven countries.

There are eighteen drug master file entries for tobramycin. Thirty-six suppliers are listed for this compound.

Summary for tobramycin

International Patents:	61
US Patents:	4
Tradenames:	11
Applicants:	36
NDAs:	64
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	124
Patent Applications:	5,481
Drug Prices:	Drug price trends 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
Teva Pharms Usa	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063100-001	Jan 30, 1992		DISCN	No	No
Hikma	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063127-001	Nov 27, 1991		DISCN	No	No
Lilly	NEBCIN	tobramycin sulfate	INJECTABLE;INJECTION	050477-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Norvium Bioscience	TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	209554-001	Oct 13, 2017		DISCN	No	No
Micro Labs	TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	217344-001	Jul 27, 2023	AN	RX	No	No
Mankind Pharma	TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	216725-001	Sep 22, 2022	AN	RX	No	No
Apothecon	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	064026-001	May 31, 1994		DISCN	No	No

Expired US Patents for tobramycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	7,696,178
Viatris	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	11,484,671
Viatris	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	8,069,851
Viatris	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	7,368,102
Viatris	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	9,421,166
Viatris	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	8,349,294
Viatris	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	8,715,623

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

International Patents for tobramycin

Country	Patent Number	Title	Estimated Expiration
Norway	20070253
Mexico	PA05010842	APARATO DE NEBULIZACION CON PROTECTOR DE ENTRADA DE AIRE. (AEROSOLIZATION APPARATUS WITH AIR INLET SHIELD.)
South Africa	200700420	Methods of treatment of endobronchial infections
European Patent Office	1610850	APPAREIL DE PULVERISATION EN AEROSOL ET ÉCRAN DE PROTECTION D'ENTRÉE D'AIR (AEROSOLIZATION APPARATUS WITH AIR INLET SHIELD)
Poland	1610850
Denmark	1610850
New Zealand	552047	Method of treatment of endobronchial infections

Supplementary Protection Certificates for tobramycin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280520	CA 2015 00017	Denmark		PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1280520	300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1273292	C01273292/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520	14/2015	Austria		PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520	C01280520/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
1280520	92678	Luxembourg		PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
1280520	C300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720

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.

Last updated: 2024-12-16