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Serving leading biopharmaceutical companies globally:

UBS
Daiichi Sankyo
Baxter
Mallinckrodt
Dow
AstraZeneca
Harvard Business School
Deloitte
Chinese Patent Office
US Army

Generated: November 21, 2017

DrugPatentWatch Database Preview

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-nine patent family members in twenty-eight countries and five supplementary protection certificates in four countries.

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

Pharmacology for tigecycline

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
TIGECYCLINE
tigecycline
POWDER;IV (INFUSION)205645-001Dec 1, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
TIGECYCLINE
tigecycline
POWDER;IV (INFUSION)091620-001May 27, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005APRXYesYes► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005APRXYesYes► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005APRXYesYes► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005APRXYesYes► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005APRXYesYes► Subscribe► 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, 2005► Subscribe► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005► Subscribe► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005► Subscribe► Subscribe
Pf Prism Cv
TYGACIL
tigecycline
POWDER;IV (INFUSION)021821-001Jun 15, 2005► Subscribe► Subscribe
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International Patent Family for Ingredient: tigecycline

Country Document Number Estimated Expiration
Russian Federation2007131396► Subscribe
South Korea20080016890► Subscribe
Taiwan200720232► Subscribe
BrazilPI0610653► Subscribe
Russian Federation2007143160► Subscribe
Guatemala200600112► Subscribe
Portugal1890996► Subscribe
Costa Rica9416► Subscribe
El Salvador2008002542► Subscribe
Chile2006001266► 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
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
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
C0031France► SubscribePRODUCT NAME: TIGECYCLINE; REGISTRATION NO/DATE: EU/01/06/336/001 20060424
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Serving leading biopharmaceutical companies globally:

McKesson
Deloitte
Merck
Cantor Fitzgerald
Boehringer Ingelheim
Mallinckrodt
Cipla
Fish and Richardson
McKinsey
Cerilliant

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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