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Last Updated: August 8, 2020

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TYBOST Drug Profile

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When do Tybost patents expire, and what generic alternatives are available?

Tybost is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy patent family members in thirty-nine 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.

US ANDA Litigation and Generic Entry Outlook for Tybost

Tybost was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4, 2032. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TYBOST
Drug Prices for TYBOST

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Generic Entry Opportunity Date for TYBOST
Generic Entry Date for TYBOST*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TYBOST

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ZonMw: The Netherlands Organisation for Health Research and DevelopmentEarly Phase 1
Academisch Ziekenhuis MaastrichtEarly Phase 1
The Netherlands Cancer InstituteEarly Phase 1

See all TYBOST clinical trials

Paragraph IV (Patent) Challenges for TYBOST
Tradename Dosage Ingredient NDA Submissiondate
TYBOST TABLET;ORAL cobicistat 203094 2016-11-14

US Patents and Regulatory Information for TYBOST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 RX Yes Yes   Start Trial   Start Trial   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 TYBOST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487166 300860 Netherlands   Start Trial PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2049506 262 5024-2015 Slovakia   Start Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZA-; REGISTRATION NO/DATE: EU/1/13/830 20130527
2487162 17C1002 France   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
2049506 CR 2015 00060 Denmark   Start Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2487163 300859 Netherlands   Start Trial PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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 verification 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.