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Last Updated: October 20, 2020

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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, Somerset Theraps Llc, Sandoz Inc, Chiesi, Pulmoflow Inc, Akorn Inc, Amneal Pharms, Dr Reddys Labs Sa, 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-three NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tobramycin has two hundred and eighty-one patent family members in forty-four countries.

There are eighteen drug master file entries for tobramycin. Thirty 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
Atlantic Health SystemPhase 4
Sutphin DrugsEarly Phase 1
University of DundeePhase 2

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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
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Baxter Hlthcare Corp TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 206965-001 Jul 1, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER tobramycin sulfate INJECTABLE;INJECTION 063081-001 Jul 31, 1990 RX No Yes   Start Trial   Start Trial   Start Trial
Watson Labs Inc TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 062945-002 Aug 9, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Mylan Speciality Lp TOBI tobramycin SOLUTION;INHALATION 050753-001 Dec 22, 1997   Start Trial   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013   Start Trial   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013   Start Trial   Start 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 CA 2015 00017 Denmark   Start Trial PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1280520 C300722 Netherlands   Start Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 14/2015 Austria   Start Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520 122015000021 Germany   Start Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1273292 C01273292/01 Switzerland   Start Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520 C01280520/01 Switzerland   Start Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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