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Last Updated: November 23, 2020

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BETHKIS Drug Profile

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Which patents cover Bethkis, and what generic alternatives are available?

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 suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

US ANDA Litigation and Generic Entry Outlook for Bethkis

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

  Start Trial

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
Chiesi Farmaceutici S.p.A.Phase 3

See all BETHKIS clinical trials

Pharmacology for BETHKIS
Paragraph IV (Patent) Challenges for BETHKIS
Tradename Dosage Ingredient NDA Submissiondate
BETHKIS SOLUTION;INHALATION tobramycin 201820 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   Start Trial   Start Trial   Start Trial
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 AN RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Chiesi BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 AN 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 BETHKIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280520 122015000021 Germany   Start 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   Start Trial PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1280520 300722 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Express Scripts
McKinsey
Johnson and Johnson
AstraZeneca

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