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Tigecycline - Generic Drug Details

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

This ingredient has ninety-eight patent family members in thirty-eight countries.

There are ten drug master file entries for tigecycline. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: tigecycline

Tradenames:2
Patents:5
Applicants:2
NDAs:2
Drug Master File Entries: see list10
Suppliers / Packaging: see list1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: tigecycline

Tentative approvals for TIGECYCLINE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION50MG
<disabled><disabled>INJECTABLE;INJECTION100MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RXYes7,879,828► subscribeY ► subscribe
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RXYes8,975,242► subscribeY ► subscribe
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RXYes8,372,995► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: tigecycline

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 20055,494,903► subscribe
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RE40086► subscribe
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RE40183► subscribe
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Non-Orange Book Patents for Generic Ingredient: tigecycline

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
RE40086Method for treating bacterial infection with novel 7-substituted-9-substituted amino 6-demethyl-6-deoxytetracyclines► subscribe
5,494,903 7-substituted-9-substituted amino-6-demethyl-6-deoxytetracyclines► subscribe
5,529,990 Method for treating bacterial infection with novel 7-substituted-9-substituted amino 6-demethyl-6-deoxytetracyclines► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: tigecycline

Country Document Number Estimated Expiration
Poland175957► subscribe
Mexico2007014735► subscribe
Peru11072006► 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
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
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
C030/2006Ireland► subscribeSPC030/2006: 20071025, EXPIRES: 20170820
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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 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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