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Last Updated: March 5, 2021

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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, Apotex, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Sandoz Inc, Xellia Pharms Aps, and Pf Prism Cv, and is included in eight NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tigecycline has seventy patent family members in twenty-nine countries.

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

Drug Prices for tigecycline

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Recent Clinical Trials for tigecycline

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

SponsorPhase
Zealand University HospitalN/A
Griffith UniversityPhase 2/Phase 3
University of MelbournePhase 2/Phase 3

See all tigecycline clinical trials

Pharmacology for tigecycline

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
Xellia Pharms Aps TIGECYCLINE tigecycline POWDER;INTRAVENOUS 205722-001 Oct 18, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa TIGECYCLINE tigecycline POWDER;INTRAVENOUS 205645-001 Dec 1, 2016 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Sandoz Inc TIGECYCLINE tigecycline POWDER;INTRAVENOUS 091620-001 May 27, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Apotex TIGECYCLINE tigecycline POWDER;INTRAVENOUS 204439-001 Dec 21, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Amneal TIGECYCLINE tigecycline POWDER;INTRAVENOUS 211158-001 Aug 2, 2018 AP RX No No   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 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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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