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Last Updated: December 6, 2019

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TIGECYCLINE - Generic Drug Details

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What are the generic sources for tigecycline and what is the scope of patent protection?

Tigecycline is the generic ingredient in two branded drugs marketed by Accord Hlthcare Inc, Amneal Pharms Llc, Apotex Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Sandoz Inc, and Pf Prism Cv, and is included in seven NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tigecycline has sixty-seven patent family members in twenty-nine countries.

There are ten drug master file entries for tigecycline. Seven suppliers are listed for this compound.

Drug Prices for TIGECYCLINE

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Recent Clinical Trials for TIGECYCLINE

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SponsorPhase
Zealand University HospitalN/A
Menarini GroupPhase 3
Shanghai 10th People's HospitalEarly Phase 1

See all TIGECYCLINE clinical trials

Recent Litigation for TIGECYCLINE

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 TIGECYCLINE 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 TIGECYCLINE litigation

Pharmacology for TIGECYCLINE
Synonyms for TIGECYCLINE
(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 (JAN/USAN)
Tigecycline [USAN:INN:BAN]
Tigecycline [USAN]
Tigecycline hydrate
Tigecycline, Antibiotic for Culture Media Use Only
Tigecyclinum
Tigilcycline
Tox21_112910
Tygacil
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 TIGECYCLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd TIGECYCLINE tigecycline POWDER;INTRAVENOUS 206335-001 Jun 11, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc TIGECYCLINE tigecycline POWDER;INTRAVENOUS 204439-001 Dec 21, 2018 AP RX No No   Start Trial   Start Trial   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
Sandoz Inc TIGECYCLINE tigecycline POWDER;INTRAVENOUS 091620-001 May 27, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Llc TIGECYCLINE tigecycline POWDER;INTRAVENOUS 211158-001 Aug 2, 2018 AP RX No No   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 TIGECYCLINE

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 TIGECYCLINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 SPC/GB06/033 United Kingdom   Start Trial PRODUCT NAME: TIGECYCLINE
0536515 06C0031 France   Start Trial PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 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
Johnson and Johnson
Mallinckrodt
Express Scripts
Baxter
Moodys

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