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Last Updated: November 22, 2019

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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 patent family members in twenty-eight countries.

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

Drug patent expirations by year for TYGACIL
Drug Prices for TYGACIL

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Recent Clinical Trials for TYGACIL

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SponsorPhase
PfizerN/A
Wyeth is now a wholly owned subsidiary of PfizerPhase 4

See all TYGACIL clinical trials

Recent Litigation for TYGACIL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Accord Healthcare, Inc.2016-02-11
Pfizer Inc. v. Mylan Laboratories Ltd.2015-10-22
Apotex Inc. v. Wyeth LLC2015-07-29

See all TYGACIL litigation

PTAB Litigation
PetitionerDate
Apotex Inc.2015-03-12
Initiative for Responsibility in Drug Pricing LLC2014-08-08
Apotex Inc.2013-11-01

See all TYGACIL litigation

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

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

Supplementary Protection Certificates for TYGACIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0536515 06C0031 France   Start Trial PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515 SPC/GB06/033 United Kingdom   Start Trial PRODUCT NAME: TIGECYCLINE
0536515 C300244 Netherlands   Start Trial 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   Start Trial 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 2006/030 Ireland   Start Trial PRODUCT NAME: TIGECYCLINE OR A PHARMACOLOGICALLY ACCEPTABLE ORGANIC OR INORGANIC SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
McKesson
Colorcon
Merck
Moodys

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