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Last Updated: May 11, 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

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SponsorPhase
Zealand University HospitalN/A
James Cook University, Queensland, AustraliaPhase 2/Phase 3
Children's Hospital FoundationPhase 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
Apotex TIGECYCLINE tigecycline POWDER;INTRAVENOUS 204439-001 Dec 21, 2018 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Xellia Pharms Aps TIGECYCLINE tigecycline POWDER;INTRAVENOUS 205722-001 Oct 18, 2019 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Amneal TIGECYCLINE tigecycline POWDER;INTRAVENOUS 211158-001 Aug 2, 2018 AP RX No No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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   Get Started for $10   Get Started for $10
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005   Get Started for $10   Get Started for $10
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005   Get Started for $10   Get Started for $10
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005   Get Started for $10   Get Started for $10
>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 SPC/GB06/033 United Kingdom   Get Started for $10 PRODUCT NAME: TIGECYCLINE
0536515 06C0031 France   Get Started for $10 PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515 C300244 Netherlands   Get Started for $10 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   Get Started for $10 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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