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Last Updated: March 19, 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. Eight 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

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

SponsorPhase
Zhujiang Hospital
Manjunath Prakash PaiPhase 4
PfizerPhase 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tigecycline compositions and methods of preparation
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Patent Expiration: ⤷  Try a Trial

Crystalline solid forms of tigecycline and methods of preparing same
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Patent Expiration: ⤷  Try a Trial

Tigecycline compositions and methods of preparation
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Patent Expiration: ⤷  Try a Trial

Tigecycline compositions and methods of preparation
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Patent Expiration: ⤷  Try a Trial

Tigecycline compositions and methods of preparation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
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
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
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
>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 ⤷  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 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
Spain 2168254 ⤷  Try a Trial
Portugal 536515 ⤷  Try a Trial
Brazil PI0610653 formas sólidas cristalinas de tigeciclina, composição compreendendo as mesmas, processo para preparação e uso das mesmas ⤷  Try a Trial
Slovakia 284826 ⤷  Try a Trial
Spain 2415518 ⤷  Try a Trial
Denmark 1890996 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TYGACIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0536515 34/2006 Austria ⤷  Try a Trial PRODUCT NAME: TIGECYCLIN UND DIE PHARMAKOLOGISCH UNBEDENKLICHEN ORGANISCHEN UND ANORGANISCHEN SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
0536515 0690028-6 Sweden ⤷  Try a Trial PRODUCT NAME: TIGECYKLIN
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
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 91279 Luxembourg ⤷  Try a Trial 91279, EXPIRES: 20170821
0536515 CA 2006 00027 Denmark ⤷  Try a Trial
>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.