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Last Updated: November 4, 2024

TOBI Drug Patent 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 seven 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. Thirty-six suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

DrugPatentWatch® 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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Summary for TOBI
Drug patent expirations by year for TOBI
Drug Prices for TOBI

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Pharmacology for TOBI
Paragraph IV (Patent) Challenges for TOBI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TOBI Inhalation Solution tobramycin 300 mg/5 mL 050753 1 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for TOBI

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

Supplementary Protection Certificates for TOBI

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

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