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Serving 500+ biopharmaceutical companies globally:

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Generated: July 20, 2017

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Tigecycline - Generic Drug Details

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What are the generic drug sources for tigecycline and what is the scope of tigecycline freedom to operate?

Tigecycline
is the generic ingredient in two branded drugs marketed by Sandoz Inc, Pf Prism Cv, and Fresenius Kabi Usa, and is included in three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tigecycline has fifty-two patent family members in twenty-eight countries.

There are ten drug master file entries for tigecycline. Two suppliers are listed for this compound.

Summary for Generic Name: tigecycline

Tradenames:2
Patents:5
Applicants:3
NDAs:3
Drug Master File Entries: see list10
Suppliers / Packagers: see list2
Bulk Api Vendors: see list63
Clinical Trials: see list49
Patent Applications: see list2,029
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tigecycline at DailyMed

Pharmacology for Ingredient: 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;IV (INFUSION)021821-001Jun 15, 2005APRXYesYes8,372,995► SubscribeY ► Subscribe
Fresenius Kabi Usa
TIGECYCLINE
tigecycline
POWDER;IV (INFUSION)205645-001Dec 1, 2016APRXNoNo► Subscribe► Subscribe
Sandoz Inc
TIGECYCLINE
tigecycline
POWDER;IV (INFUSION)091620-001May 27, 2015APRXNoNo► Subscribe► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005APRXYesYes8,975,242► SubscribeY ► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005APRXYesYes9,254,328► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tigecycline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 20055,494,903► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005RE40086► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005RE40183► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 20055,529,990► Subscribe
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International Patent Family for Ingredient: tigecycline

Country Document Number Estimated Expiration
Denmark1858488► Subscribe
Canada2609875► Subscribe
Australia2006251954► Subscribe
Canada2602089► Subscribe
Taiwan200720232► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TIGECYCLINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00244Netherlands► SubscribePRODUCT: 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
0244Netherlands► SubscribePRODUCT: 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
06/030Ireland► SubscribePRODUCT NAME: TIGECYCLINE OR A PHARMACOLOGICALLY ACCEPTABLE ORGANIC OR INORGANIC SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
C/GB06/033United Kingdom► SubscribePRODUCT NAME: TIGECYCLINE
C0031France► SubscribePRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Healthtrust
Accenture
UBS
Novartis
Chinese Patent Office
Federal Trade Commission
Merck
Chubb
Harvard Business School
Medtronic

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 verifification 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.

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