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Generated: September 20, 2018

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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.

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.

Drug patent expirations by year 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.

Medical Subject Heading (MeSH) Categories for TYBOST
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
AK174896
AKOS025404908
AOB87771
AS-17061
BDBM50447471
CHEBI:72291
CHEMBL2095208
Cobicistat
Cobicistat (GS-9350)
Cobicistat (JAN/USAN/INN)
Cobicistat [USAN:INN]
Cobicistat,GS-9350
Cobicistat/darunavir
cobicistatum
CS-0742
D02VJP
D09881
D0V4ZN
DB09065
DTXSID00143269
GS 9350
GS-9350
GTPL7535
HY-10493
KB-76152
KS-00000T52
LW2E03M5PG
MFCD18251449
MolPort-035-395-741
QCR-199
s2900
SCHEMBL2736227
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

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc TYBOST cobicistat TABLET;ORAL 203094-001 Sep 24, 2014 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 TYBOST
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 150 mg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for 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
7,939,553 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
8,486,942 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
8,383,655 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
8,088,770 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
8,067,449 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
9,139,541 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for TYBOST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016000103 Germany ➤ Try a Free Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119
0860 Netherlands ➤ Try a Free 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
2016039 Lithuania ➤ Try a Free Trial PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
16/061 Ireland ➤ Try a Free 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
2016038 Lithuania ➤ Try a Free Trial PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
90001-0 Sweden ➤ Try a Free Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123
2015040,C2049506 Lithuania ➤ Try a Free Trial PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Covington
Chinese Patent Office
Farmers Insurance
AstraZeneca
Citi
Cantor Fitzgerald
Express Scripts
US Army

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