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Last Updated: October 5, 2022

BETHKIS Drug Patent Profile


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

Bethkis is a drug marketed by Chiesi and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in twenty-six countries.

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

See drug prices for BETHKIS

Recent Clinical Trials for BETHKIS

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

SponsorPhase
Mylan Inc.
Cystic Fibrosis Foundation Therapeutics
Novartis Pharmaceuticals

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

BETHKIS is protected by three US patents.

Patents protecting BETHKIS

Optimized formulation of tobramycin for aerosolization
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Optimised formulation of tobramycin for aerosolization
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Optimised formulation of tobramycin for aerosolization
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF CYSTIC FIBROSIS PATIENTS

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 AN RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 AN RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 See Plans and Pricing See Plans and Pricing
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 See Plans and Pricing See Plans and Pricing
>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
Mylan Ireland 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 yes 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
Bulgaria 108475 See Plans and Pricing
Hong Kong 1068784 See Plans and Pricing
World Intellectual Property Organization (WIPO) 03004005 See Plans and Pricing
Portugal 1273292 See Plans and Pricing
Australia 2002319226 See Plans and Pricing
Hungary 0400387 See Plans and Pricing
China 1234346 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BETHKIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 CA 2015 00017 Denmark See Plans and Pricing PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1280520 C300722 Netherlands See Plans and Pricing PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520 14/2015 Austria See Plans and Pricing PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520 C01280520/01 Switzerland See Plans and Pricing PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
1280520 122015000021 Germany See Plans and Pricing PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1273292 C01273292/01 Switzerland See Plans and Pricing PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520 92678 Luxembourg See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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Baxter
Express Scripts

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