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Last Updated: March 19, 2024

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, Eugia Pharma, Fresenius Kabi Usa, Meitheal, Sandoz, Xellia Pharms Aps, and Pf Prism Cv, and is included in nine 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
Zhengzhou Sixth People's Hospital, ChinaPhase 4
No.85 Hospital, Changning, Shanghai, ChinaPhase 4
Shanghai Pudong New Area Pulmonary Hospital, ChinaPhase 4

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
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Xellia Pharms Aps TIGECYCLINE tigecycline POWDER;INTRAVENOUS 205722-001 Oct 18, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

Country Patent Number Title Estimated Expiration
Spain 2415518 ⤷  Try a Trial
South Africa 200710151 Crystalline solid forms of tigecycline and methods of preparing same ⤷  Try a Trial
Japan 2008545717 ⤷  Try a Trial
Russian Federation 2007143160 КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ТАЙГЕЦИКЛИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tigecycline

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0536515 06C0031 France ⤷  Try a Trial PRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
0536515 300244 Netherlands ⤷  Try a 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 ⤷  Try a 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 C300244 Netherlands ⤷  Try a 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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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.