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Last Updated: December 10, 2024

TYGACIL Drug Patent Profile


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

Tygacil is a drug marketed by Pf Prism Cv and is included in one NDA. There are six patents protecting this drug.

This drug has sixty-two patent family members in twenty-nine countries.

The generic ingredient in TYGACIL 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 Tygacil

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

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Drug patent expirations by year for TYGACIL
Drug Prices for TYGACIL

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Recent Clinical Trials for TYGACIL

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SponsorPhase
Zhujiang Hospital
PfizerPhase 4
Manjunath Prakash PaiPhase 4

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Pharmacology for TYGACIL

US Patents and Regulatory Information for TYGACIL

TYGACIL is protected by six US patents.

Patents protecting TYGACIL

Tigecycline compositions and methods of preparation
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Tigecycline compositions and methods of preparation
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Crystalline solid forms of tigecycline and methods of preparing same
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Tigecycline compositions and methods of preparation
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Tigecycline compositions and methods of preparation
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Tigecycline compositions and methods of preparation
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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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 AP RX Yes Yes ⤷  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

Expired US Patents for TYGACIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Sign Up ⤷  Sign Up
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TYGACIL

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 TYGACIL

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

Country Patent Number Title Estimated Expiration
Peru 20070024 FORMAS SOLIDAS CRISTALINAS DE TIGECICLINA Y METODOS PARA PREPARAR LAS MISMAS ⤷  Sign Up
Honduras 2006011218 COMPOSICIONES DE TIGECICLINA Y MÉTODOS DE PREPARACIÓN ⤷  Sign Up
Cyprus 1114253 ⤷  Sign Up
Norway 923857 ⤷  Sign Up
South Korea 20080016890 CRYSTALLINE SOLID FORMS OF TIGECYCLINE AND METHODS OF PREPARING SAME ⤷  Sign Up
Russian Federation 2007143160 КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ТАЙГЕЦИКЛИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TYGACIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0536515 CA 2006 00027 Denmark ⤷  Sign Up
0536515 34/2006 Austria ⤷  Sign Up PRODUCT NAME: TIGECYCLIN UND DIE PHARMAKOLOGISCH UNBEDENKLICHEN ORGANISCHEN UND ANORGANISCHEN SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
0536515 C00536515/01 Switzerland ⤷  Sign Up FORMER OWNER: WYETH HOLDINGS CORPORATION, US
0536515 SPC/GB06/033 United Kingdom ⤷  Sign Up PRODUCT NAME: TIGECYCLINE
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 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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