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TYGACIL Drug Profile

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

Tygacil is a drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-two patent family members in twenty-nine countries.

The generic ingredient in TYGACIL is tigecycline. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tigecycline profile page.

US ANDA Litigation and Generic Entry Outlook for Tygacil

A generic version of TYGACIL was approved as tigecycline by SANDOZ INC on May 27^th, 2015.

Summary for TYGACIL

International Patents:	62
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	78
Clinical Trials:	5
Patent Applications:	1,863
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TYGACIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYGACIL
DailyMed Link:	TYGACIL at DailyMed

See drug prices for TYGACIL

Recent Clinical Trials for TYGACIL

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

Sponsor	Phase
Pfizer	N/A
Wyeth is now a wholly owned subsidiary of Pfizer	Phase 4

See all TYGACIL clinical trials

Recent Litigation for TYGACIL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Pfizer Inc. v. Accord Healthcare, Inc.	2016-02-11
Pfizer Inc. v. Mylan Laboratories Ltd.	2015-10-22
Apotex Inc. v. Wyeth LLC	2015-07-29

See all TYGACIL litigation

PTAB Litigation

Petitioner	Date
Apotex Inc.	2015-03-12
Initiative for Responsibility in Drug Pricing LLC	2014-08-08
Apotex Inc.	2013-11-01

See all TYGACIL litigation

Pharmacology for TYGACIL

Drug Class

Tetracycline-class Antibacterial

Synonyms for TYGACIL

(4S,12aS)-4,7-Bis(dimethylamino)-9-{2-[(tert-butyl)amino]acetylamino}-3,10,12,12a-tetrahydroxy-1,11-dioxo-4,5,6,12a,4a,5a-hexahydronaphthacene-2-carboxamide

(4S,4aS,5aR,12aS)-9-(2-(tert-butylamino)acetamido)-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide

(4S,4aS,5aR,12aS)-9-(2-(tert-Butylamino)acetamido)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1

(4S,4AS,5aR,12aS)-9-(2-(tert-butylamino)acetamido)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxa

(4S,4aS,5aR,12aS)-9-(2-(tert-butylamino)acetamido)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide

(4s,4as,5ar,12as)-9-(2-t-butylaminoacetylamino)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydronaphthacene-2-carboxamide

(4S,4aS,5aR,12aS)-9-[(N-tert-butylglycyl)amino]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide

(4S,4aS,5aR,12aS)-9-[[2-(tert-butylamino)acetyl]amino]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide

(4S,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide

121GE002

2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-9-((((1,1-dimethylethyl)amino)acetyl)amino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4S,4aS,5aR,12aS)-

2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-9-((((1,1-dimethylethyl)amino)acetyl)amino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4S,4aS,5aR,12aS)-

2-NAPHTHACENECARBOXAMIDE, 4,7-BIS(DIMETHYLAMINO)-9-[[[(1,1-DIMETHYLETHYL)AMINO]ACETYL]AMINO]-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-3,10,12,12A-TETRAHYDROXY-1,11-DIOXO-, (4S,4AS,5AR,12AS)-

2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-9-[[2-[(1,1-dimethylethyl)amino]acetyl]amino]-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4S,4aS,5aR,12aS)-

220620-09-7

220620-09-7 (anhy.)

620T097

70JE2N95KR

9-t-Butylglycylamido minocycline

9-t-Butylglycylamido-minocycline hydrate

9-tert-Butylglycylamidominocycline

A5226

AB0011463

AB01566818_01

AB2000089

AC-1798

AC1NQZEU

AC1O714W

ACT08710

AKOS015895663

AKOS025401452

AM20090708

AN-6306

AS-30703

BC677670

BCP01397

BCPP000045

BR-73038

C12012

C29H39N5O8

CAS-220620-09-7

CHEBI:149836

CHEMBL376140

CS-1876

CT0198

D01079

DB00560

DSSTox_CID_28507

DSSTox_GSID_48581

DSSTox_RID_82779

DTXSID2048581

FPZLLRFZJZRHSY-HJYUBDRYSA-N

FT-0657279

GAR 936

GAR-936

GAR-936,Tigecycline

Haizheng Li Xing

HMS3714I13

HSDB 8172

HY-B0117

I06-1089

LS-186580

LS-187002

LS-187782

MLS006010079

MolPort-009-199-379

MolPort-028-751-260

N-((5aR,6aS,7S,10aS,Z)-9-(amino(hydroxy)methylene)-4,7-bis(dimethylamino)-1,10a,12-trihydroxy-8,10,11-trioxo-5,5a,6,6a,7,8,9,10,10a,11-decahydrotetracen-2-yl)-2-(tert-butylamino)acetamide

N-[(5aR,6aS,7S,9E,10aS)-9-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-1,10a,12-trihydroxy-8,10,11-trioxo-5a,6,6a,7-tetrahydro-5H-tetracen-2-yl]-2-(tert-butylamino)acetamide

N-[(5aR,6aS,7S,9Z,10aS)-9-[amino(hydroxy)methylene]-4,7-bis(dimethylamino)-1,10a,12-trihydroxy-8,10,11-trioxo-5a,6,6a,7-tetrahydro-5H-tetracen-2-yl]-2-(tert-butylamino)acetamide

N-[(5aR,6aS,7S,9Z,10aS)-9-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-1,10a,12-trihydroxy-8,10,11-trioxo-5a,6,6a,7-tetrahydro-5H-tetracen-2-yl]-2-(tert-butylamino)acetamide

NCGC00183095-01

PubChem21336

Q-101396

RL02680

S-5066

s1403

SC-20200

SCHEMBL101795

SCHEMBL105082

SCHEMBL237962

SMR002530064

SOVUOXKZCCAWOJ-HJYUBDRYSA-N

ST2413997

SYN3024

TBG-MINO

Tigeciclina

Tigecyclin

Tigecycline

Tigecycline (JAN/USAN)

Tigecycline [USAN:INN:BAN]

Tigecycline [USAN]

Tigecycline hydrate

Tigecycline, Antibiotic for Culture Media Use Only

Tigecyclinum

Tigilcycline

Tox21_112910

Tygacil (TN)

Tygacil;GAR-936;WAY-GAR-936;TBG-MINO

Tygacil(TM)

UNII-70JE2N95KR

WAY-GAR-936

ZINC100022633

ZINC102200515

ZINC14879972

US Patents and Regulatory Information for TYGACIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005	AP	RX	Yes	Yes			Y

Expired US Patents for TYGACIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821-001	Jun 15, 2005

International Patents for TYGACIL

Country	Patent Number	Estimated Expiration
Denmark	1890996
European Patent Office	1858488
Japan	2008545717
Japan	2013100354
Canada	2602089
Guatemala	200600112

Supplementary Protection Certificates for TYGACIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0536515	06C0031	France		PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515	2006/030	Ireland		PRODUCT NAME: TIGECYCLINE OR A PHARMACOLOGICALLY ACCEPTABLE ORGANIC OR INORGANIC SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
0536515	C300244	Netherlands		PRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424
0536515	300244	Netherlands		PRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424
0536515	SPC/GB06/033	United Kingdom		PRODUCT NAME: TIGECYCLINE