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Last Updated: March 28, 2024

BETHKIS Drug Patent Profile


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When do Bethkis patents expire, and what generic alternatives are available?

Bethkis is a drug marketed by Chiesi and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Bethkis

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

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Drug patent expirations by year for BETHKIS
Drug Prices for BETHKIS

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Recent Clinical Trials for BETHKIS

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

SponsorPhase
Novartis Pharmaceuticals
Cystic Fibrosis Foundation
Mylan Inc.

See all BETHKIS clinical trials

Pharmacology for BETHKIS
Paragraph IV (Patent) Challenges for BETHKIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BETHKIS Inhalation Solution tobramycin 300 mg/4 mL 201820 1 2017-08-31

US Patents and Regulatory Information for BETHKIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 AN RX Yes Yes ⤷  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 BETHKIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 ⤷  Try a Trial ⤷  Try a Trial
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 ⤷  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 BETHKIS

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 BETHKIS

See the table below for patents covering BETHKIS around the world.

Country Patent Number Title Estimated Expiration
South Korea 20040018403 ⤷  Try a Trial
Hungary 230807 Optimised formulation of tobramycin for aerosolization ⤷  Try a Trial
Japan 4262086 ⤷  Try a Trial
Egypt 24019 Optimised formulation of tobramycin for aerosolization ⤷  Try a Trial
Spain 2222294 ⤷  Try a Trial
Brazil PI0211320 Formulação de tobramicina para aerossolização ⤷  Try a Trial
European Patent Office 1273292 Formulation optimisée de tobramycine pour administration sous forme d'aérosol (Optimised formulation of tobramycin for aerosolization) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BETHKIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 14/2015 Austria ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1280520 C300722 Netherlands ⤷  Try a Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 300722 Netherlands ⤷  Try a Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 C01280520/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
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
1280520 92678 Luxembourg ⤷  Try a Trial PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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