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Last Updated: August 9, 2020

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TOBI Drug Profile

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Which patents cover Tobi, and when can generic versions of Tobi launch?

Tobi is a drug marketed by Mylan Speciality Lp and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in TOBI is tobramycin. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

US ANDA Litigation and Generic Entry Outlook for Tobi

A generic version of TOBI was approved as tobramycin by BAUSCH AND LOMB on November 29th, 1993.

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Paragraph IV (Patent) Challenges for TOBI
Tradename Dosage Ingredient NDA Submissiondate
TOBI SOLUTION;INHALATION tobramycin 050753 2009-06-29

US Patents and Regulatory Information for TOBI

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   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 Y   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 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

Supplementary Protection Certificates for TOBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 C300722 Netherlands   Start Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 92678 Luxembourg   Start Trial PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
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
1273292 C01273292/01 Switzerland   Start Trial 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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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Medtronic
Johnson and Johnson
Baxter
Dow

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