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Pharmaceutical Business Intelligence

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TYBOST Drug Profile

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Tybost is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ninety-one patent family members in twenty-six countries.

The generic ingredient in TYBOST is cobicistat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat profile page.

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc
TYBOST
cobicistat
TABLET;ORAL203094-001Sep 24, 2014RXYes8,148,374► subscribeYY ► subscribe
Gilead Sciences Inc
TYBOST
cobicistat
TABLET;ORAL203094-001Sep 24, 2014RXYes► subscribe► subscribe
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Paragraph IV activity for: TYBOST

Drugname Dosage Strength RLD Submissiondate
cobicistatTablets150 mgTybost12/9/2015

Non-Orange Book Patents for Tradename: TYBOST

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
7,939,553Modulators of pharmacokinetic properties of therapeutics► subscribe
8,486,942Modulators of pharmacokinetic properties of therapeutics► subscribe
8,383,655Modulators of pharmacokinetic properties of therapeutics► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TYBOST

Country Document Number Estimated Expiration
New Zealand612093► subscribe
Japan5393665► subscribe
European Patent Office2487168► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TYBOST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00060Denmark► subscribePRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
864Luxembourg► subscribePRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20130527
2015040Lithuania► subscribePRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
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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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