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Last Updated: July 13, 2024

TIGECYCLINE Drug Patent 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, Eugia Pharma, Fresenius Kabi Usa, Meitheal, Sandoz, and Xellia Pharms Aps. and is included in eight 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. Seven 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 on May 27th, 2015.

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Drug patent expirations by year for TIGECYCLINE
Drug Prices for TIGECYCLINE

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Recent Clinical Trials for TIGECYCLINE

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

SponsorPhase
Tata Memorial CentrePhase 2
Shanghai Pulmonary Hospital, Shanghai, ChinaPhase 4
Shanghai Public Health Clinical CenterPhase 4

See all TIGECYCLINE clinical trials

Pharmacology for TIGECYCLINE
Anatomical Therapeutic Chemical (ATC) Classes for TIGECYCLINE

US Patents and Regulatory Information for TIGECYCLINE

TIGECYCLINE is protected by one US patents.

Patents protecting TIGECYCLINE

Tigecycline composition for injection
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz TIGECYCLINE tigecycline POWDER;INTRAVENOUS 091620-001 May 27, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma TIGECYCLINE tigecycline POWDER;INTRAVENOUS 206335-001 Jun 11, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Xellia Pharms Aps TIGECYCLINE tigecycline POWDER;INTRAVENOUS 205722-001 Oct 18, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal TIGECYCLINE tigecycline POWDER;INTRAVENOUS 211158-001 Aug 2, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for TIGECYCLINE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Accord Healthcare S.L.U. Tigecycline Accord tigecycline EMEA/H/C/005114
Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4)Complicated intra-abdominal infections (cIAI)Tygecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised yes no no 2020-04-17
Pfizer Europe MA EEIG Tygacil tigecycline EMEA/H/C/000644
Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections:, , , Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections, Complicated intra-abdominal infections (cIAI), , , Tygacil should be used only in situations where other alternative antibiotics are not suitable., , Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.,
Authorised no no no 2006-04-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TIGECYCLINE

See the table below for patents covering TIGECYCLINE around the world.

Country Patent Number Title Estimated Expiration
Poland 2881109 ⤷  Sign Up
China 103315947 Tigecycline composition for injection ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2013139179 ⤷  Sign Up
Spain 2795421 ⤷  Sign Up
European Patent Office 2881109 COMPOSITION DE TIGECYCLINE DESTINÉE À ÊTRE INJECTÉE (TIGECYCLINE COMPOSITION FOR INJECTION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TIGECYCLINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0536515 SPC/GB06/033 United Kingdom ⤷  Sign Up PRODUCT NAME: TIGECYCLINE
0536515 06C0031 France ⤷  Sign Up PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515 2006/030 Ireland ⤷  Sign Up 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 C300244 Netherlands ⤷  Sign Up 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 ⤷  Sign Up 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.