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Last Updated: March 19, 2024

TOBRAMYCIN - Generic Drug Details


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What are the generic drug sources for tobramycin and what is the scope of freedom to operate?

Tobramycin is the generic ingredient in eleven branded drugs marketed by Novartis, Mylan Speciality Lp, Epic Pharma Llc, Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb, Chartwell Rx, Gland Pharma Ltd, Somerset Theraps Llc, Sandoz, Chiesi, Pulmoflow Inc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Hikma, Luoxin Aurovitas, Lupin, Mankind Pharma, Micro Labs, Mylan, Sun Pharm, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in sixty-four NDAs. There are eight 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-three 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

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SponsorPhase
University of UtahEarly Phase 1
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
Hospira TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063161-001 May 29, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lilly NEBCIN tobramycin sulfate INJECTABLE;INJECTION 062008-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin TOBRAMYCIN tobramycin SOLUTION;INHALATION 208964-001 Mar 22, 2017 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065122-001 Nov 29, 2002 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc AKTOB tobramycin SOLUTION/DROPS;OPHTHALMIC 064096-001 Jan 31, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Mylan Speciality Lp TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 ⤷  Try a Trial ⤷  Try a Trial
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 ⤷  Try a Trial ⤷  Try a Trial
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 ⤷  Try a Trial ⤷  Try a Trial
>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
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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TOBRAMYCIN

Country Patent Number Title Estimated Expiration
Spain 2399279 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006002178 ⤷  Try a Trial
Japan 2012107047 METHOD OF TREATMENT OF ENDOBRONCHIAL INFECTION ⤷  Try a Trial
New Zealand 552047 Method of treatment of endobronchial infections ⤷  Try a Trial
Canada 2520032 APPAREIL DE PULVERISATION EN AEROSOL ET ECRAN DE PROTECTION D'ENTREE D'AIR (AEROSOLIZATION APPARATUS WITH AIR INLET SHIELD) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TOBRAMYCIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 C01280520/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
1280520 C300722 Netherlands ⤷  Try a Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1273292 C01273292/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520 300722 Netherlands ⤷  Try a Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 122015000021 Germany ⤷  Try a Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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