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Last Updated: December 7, 2022

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 Inc, 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-one patent family members in thirty 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
Shanghai Pulmonary Hospital, Shanghai, ChinaPhase 4
Shanghai Public Health Clinical CenterPhase 4
Anhui Chest HospitalPhase 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 See Plans and Pricing See Plans and Pricing
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 See Plans and Pricing See Plans and Pricing
>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

Supplementary Protection Certificates for tigecycline

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0536515 300244 Netherlands See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: TIGECYCLINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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