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Last Updated: October 26, 2021

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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, Mylan, Sun Pharm, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, West-ward Pharms Int, Xellia Pharms Aps, and Xgen Pharms, and is included in fifty-nine NDAs. There are thirteen 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-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

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

SponsorPhase
Arun AnejaPhase 3
United States Department of DefensePhase 3
M.D. Anderson Cancer CenterPhase 2

See all tobramycin clinical trials

Pharmacology for tobramycin
Medical Subject Heading (MeSH) Categories for tobramycin
Paragraph IV (Patent) Challenges for TOBRAMYCIN
Tradename Dosage Ingredient NDA Submissiondate
BETHKIS SOLUTION;INHALATION tobramycin 201820 2017-08-31
TOBI SOLUTION;INHALATION tobramycin 050753 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
Luoxin Aurovitas TOBRAMYCIN tobramycin SOLUTION;INHALATION 210871-001 Jan 22, 2021 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 050541-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hospira TOBRAMYCIN SULFATE (PHARMACY BULK) tobramycin sulfate INJECTABLE;INJECTION 063116-001 May 18, 1992 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lilly NEBCIN tobramycin sulfate INJECTABLE;INJECTION 050519-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Speciality Lp TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tobramycin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 C300722 Netherlands ⤷  Free Forever Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 300722 Netherlands ⤷  Free Forever Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 14/2015 Austria ⤷  Free Forever Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520 CA 2015 00017 Denmark ⤷  Free Forever Trial PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
AstraZeneca
Medtronic
Mallinckrodt
Johnson and Johnson

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