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Last Updated: January 22, 2020

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TYBOST Drug Profile

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

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 sixty-two 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

  Start Trial

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4th, 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.

Drug patent expirations by year for TYBOST
Drug Prices for TYBOST

See drug prices for TYBOST

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

See all TYBOST clinical trials

Recent Litigation for TYBOST

Identify potential future generic entrants

District Court Litigation
Case NameDate
Gilead Sciences, Inc. v. Mylan Pharmaceuticals Inc.2017-02-22
Gilead Sciences Inc. v. Mylan Pharmaceuticals Inc.2016-03-25
Gilead Sciences, Inc. v. Lee2013-12-11

See all TYBOST litigation

Synonyms for TYBOST
1,3-thiazol-5-ylmethyl [(2R,5R)-5-{[(2S)-2-({[(2-isopropyl-1,3-thiazol-4-yl)methyl](methyl)carbamoyl}amino)-4-(morpholin-4-yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate
1,3-thiazol-5-ylmethyl N-[(2R,5R)-5-[[(2S)-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]-4-morpholin-4-ylbutanoyl]amino]-1,6-diphenylhexan-2-yl]carbamate
1004316-88-4
2,7,10,12-Tetraazatridecanoic acid, 12-methyl-13-(2-(1-methylethyl)-4-thiazolyl)-9-(2-(4-morpholinyl)ethyl)-8,11-dioxo-3,6-bis(phenylmethyl)-, 5-thiazolylmethyl ester, (3R,6R,9S)-
AB0093115
AB01566899_01
AC-28961
AKOS025404908
AOB87771
AS-17061
BCP06630
BDBM50447471
CHEBI:72291
CHEMBL2095208
Cobicistat
Cobicistat (GS-9350)
Cobicistat (JAN/USAN/INN)
Cobicistat [USAN:INN]
Cobicistat,GS-9350
Cobicistat; GS-9350
cobicistatum
CS-0742
D09881
DB09065
DTXSID00143269
EX-A2578
GS 9350
GS-9350
GTPL7535
HY-10493
KB-76152
KS-00000T52
LW2E03M5PG
MolPort-035-395-741
QCR-199
s2900
SB16687
SCHEMBL2736227
SW219553-1
Thiazol-5-ylmethyl ((1R,4R)-1-benzyl-4-({(2S)-2-((methyl{(2-(1-methylethyl)thiazol-4-yl)methyl}carbamoyl)amino)-4-(morpholin-4-yl)butanoyl}amino)-5-phenylpentyl)carbamate
thiazol-5-ylmethyl ((2R,5R)-5-((S)-2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-4-morpholinobutanamido)-1,6-diphenylhexan-2-yl)carbamate
thiazol-5-ylmethyl (2R,5R)-5-((S)-2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-4-morpholinobutanamido)-1,6-diphenylhexan-2-ylcarbamate
thiazol-5-ylmethyl N-[(1R,4R)-1-benzyl-4-[[(2S)-2-[[(2-isopropylthiazol-4-yl)methyl-methyl-carbamoyl]amino]-4-morpholino-butanoyl]amino]-5-phenyl-pentyl]carbamate
Tybost (TN)
UNII-LW2E03M5PG
ZCIGNRJZKPOIKD-CQXVEOKZSA-N
ZINC85537014
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
2487163 C20170001 00217 Estonia   Start Trial PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2487166 2016/061 Ireland   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487163 1790002-8 Sweden   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715
2049506 2015C/058 Belgium   Start Trial PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.