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Last Updated: June 15, 2021

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TIGECYCLINE Drug Profile


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Which patents cover Tigecycline, and when can generic versions of Tigecycline launch?

Tigecycline is a drug marketed by Accord Hlthcare Inc, Amneal, Apotex, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Sandoz Inc, and Xellia Pharms Aps. and is included in seven NDAs. There is one patent protecting this drug.

This drug has eight patent family members in eight countries.

The generic ingredient in TIGECYCLINE 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tigecycline

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

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Drug patent expirations by year for TIGECYCLINE
Drug Prices for TIGECYCLINE

See drug prices for TIGECYCLINE

Recent Clinical Trials for TIGECYCLINE

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

SponsorPhase
Zealand University HospitalN/A
Monash UniversityPhase 2/Phase 3
Cystic Fibrosis 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
Accord Hlthcare Inc TIGECYCLINE tigecycline POWDER;INTRAVENOUS 208744-001 Jan 18, 2018 RX No No   Get Started Free   Get Started Free   Get Started Free
Xellia Pharms Aps TIGECYCLINE tigecycline POWDER;INTRAVENOUS 205722-001 Oct 18, 2019 AP RX No No   Get Started Free   Get Started Free   Get Started Free
Aurobindo Pharma Ltd TIGECYCLINE tigecycline POWDER;INTRAVENOUS 206335-001 Jun 11, 2019 AP RX No No   Get Started Free   Get Started Free   Get Started Free
Amneal TIGECYCLINE tigecycline POWDER;INTRAVENOUS 211158-001 Aug 2, 2018 AP RX No No   Get Started Free   Get Started Free Y   Get Started Free
Apotex TIGECYCLINE tigecycline POWDER;INTRAVENOUS 204439-001 Dec 21, 2018 AP RX No No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TIGECYCLINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0536515 C300244 Netherlands   Get Started Free 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 Free 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   Get Started Free 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   Get Started Free PRODUCT NAME: TIGECYCLINE
0536515 06C0031 France   Get Started Free PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Colorcon
Mallinckrodt
Boehringer Ingelheim
McKinsey

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