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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Moodys
Farmers Insurance
Express Scripts
Baxter
Fuji
Teva
Federal Trade Commission
AstraZeneca

Generated: April 23, 2018

DrugPatentWatch Database Preview

BETHKIS Drug Profile

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When do Bethkis patents expire, and when can generic versions of Bethkis launch?

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. Twenty-two suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for BETHKIS
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Chiesi Usa Inc BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 Submissiondate
➤ Subscribe Inhalation Solution 300 mg/4 mL ➤ Subscribe 2017-08-31

Non-Orange Book US Patents for BETHKIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,168,598 Optimised formulation of tobramycin for aerosolization ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for BETHKIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1273292/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
0722 Netherlands ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
2015000021 Germany ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cipla
US Department of Justice
Accenture
Federal Trade Commission
Colorcon
Farmers Insurance
Express Scripts
Queensland Health

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