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Last Updated: January 27, 2023

Tobramycin - Generic Drug Details


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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, Mylan Speciality Lp, Akorn, Alcon Pharms Ltd, Alembic Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Gland Pharma Ltd, Somerset Theraps Llc, Sandoz Inc, Chiesi, Pulmoflow Inc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Luoxin Aurovitas, Lupin, Mankind Pharma, Mylan, Sun Pharm, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in sixty NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tobramycin has one hundred and sixteen patent family members in thirty-seven countries.

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

Drug Prices for tobramycin

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Drug Sales Revenue Trends for tobramycin

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Recent Clinical Trials for tobramycin

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

SponsorPhase
Medical University of South CarolinaPhase 4
Chris GossPhase 4
University of WashingtonPhase 4

See all tobramycin clinical trials

Pharmacology for tobramycin
Medical Subject Heading (MeSH) Categories for tobramycin
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
Mylan Speciality Lp TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997 AN RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063118-001 Jul 29, 1991 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 050789-001 Jul 13, 2004 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin TOBRAMYCIN tobramycin SOLUTION;INHALATION 208964-001 Mar 22, 2017 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063128-001 Nov 27, 1991 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 See Plans and Pricing See Plans and Pricing
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 See Plans and Pricing See Plans and Pricing
Mylan Speciality Lp TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997 See Plans and Pricing See Plans and Pricing
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 See Plans and Pricing See Plans and Pricing
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for tobramycin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Ireland 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 yes 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for tobramycin

Country Patent Number Title Estimated Expiration
Denmark 1765288 See Plans and Pricing
Canada 2520032 APPAREIL DE PULVERISATION EN AEROSOL ET ECRAN DE PROTECTION D'ENTREE D'AIR (AEROSOLIZATION APPARATUS WITH AIR INLET SHIELD) See Plans and Pricing
Spain 2383367 See Plans and Pricing
Germany 60103527 See Plans and Pricing
Egypt 24019 Optimised formulation of tobramycin for aerosolization See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tobramycin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 14/2015 Austria See Plans and Pricing PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520 C300722 Netherlands See Plans and Pricing PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 92678 Luxembourg See Plans and Pricing PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
1280520 122015000021 Germany See Plans and Pricing PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1273292 C01273292/01 Switzerland See Plans and Pricing PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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