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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-one 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.

Summary for TYBOST

International Patents:	261
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	52
Clinical Trials:	3
Patent Applications:	51
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TYBOST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYBOST
DailyMed Link:	TYBOST at DailyMed

See drug prices for TYBOST

Generic Entry Opportunity Date for TYBOST

NDA:

203094

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

Sponsor	Phase
The Netherlands Cancer Institute	Early Phase 1
ZonMw: The Netherlands Organisation for Health Research and Development	Early Phase 1
Academisch Ziekenhuis Maastricht	Early Phase 1

See all TYBOST clinical trials

Recent Litigation for TYBOST

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Gilead Sciences, Inc. v. Mylan Pharmaceuticals Inc.	2017-02-22
Gilead Sciences Inc. v. Mylan Pharmaceuticals Inc.	2016-03-25
Gilead Sciences, Inc. v. Lee	2013-12-11

See all TYBOST litigation

Pharmacology for TYBOST

Drug Class	Cytochrome P450 3A Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Breast Cancer Resistance Protein Inhibitors

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

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			Y	Y
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014		RX	Yes	Yes			Y

Paragraph IV (Patent) Challenges for TYBOST

Drugname	Dosage	Strength	RLD	Date
	Tablets	150 mg

International Patents for TYBOST

Country	Patent Number	Estimated Expiration
Cyprus	1118232
Portugal	2487163
China	101796040
New Zealand	594214
Serbia	55280

Supplementary Protection Certificates for TYBOST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	92864	Luxembourg		PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527
2487163	2017002	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2049506	PA2015040	Lithuania		PRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2487163	C20170001 00217	Estonia		PRODUCT NAME: ATASANAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/15/1025 15.07.2015
2487162	61/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121