BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Baxter
Farmers Insurance
Julphar
Queensland Health
Mallinckrodt
McKesson
Cerilliant
Dow
US Army
Harvard Business School

Generated: January 22, 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-seven 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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Chiesi Usa Inc BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Chiesi Usa Inc BETHKIS tobramycin SOLUTION;INHALATION 201820-001 Oct 12, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 8/31/2017

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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for BETHKIS

Supplementary Protection Certificates for BETHKIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0722 Netherlands ➤ Subscribe PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
2015 00017 Denmark ➤ Subscribe PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
678 Luxembourg ➤ Subscribe PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
1273292/01 Switzerland ➤ Subscribe PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
00722 Netherlands ➤ Subscribe PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
/2015 Austria ➤ Subscribe PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
2015000021 Germany ➤ Subscribe 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 leading biopharmaceutical companies globally:

Argus Health
McKesson
QuintilesIMS
Medtronic
Federal Trade Commission
Julphar
Chinese Patent Office
US Army
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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