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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Teva
Moodys
Julphar
Citi
Colorcon
UBS
Merck
McKesson

Generated: December 12, 2018

DrugPatentWatch Database Preview

BETHKIS Drug Profile

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

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

This drug has thirty-six 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.

Drug patent expirations by year for BETHKIS
Pharmacology for BETHKIS
Medical Subject Heading (MeSH) Categories for BETHKIS

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 Usa Inc BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Chiesi Usa Inc BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Chiesi Usa Inc BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 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

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Paragraph IV (Patent) Challenges for BETHKIS
Drugname Dosage Strength RLD Date
➤ Subscribe Inhalation Solution 300 mg/4 mL ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for BETHKIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2015 Austria ➤ Sign Up PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
00722 Netherlands ➤ Sign Up PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
2015 00017 Denmark ➤ Sign Up PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1273292/01 Switzerland ➤ Sign Up PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
678 Luxembourg ➤ Sign Up PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
US Army
Merck
Julphar
McKinsey
UBS
Federal Trade Commission
Medtronic
Johnson and Johnson

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