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TYGACIL Drug Profile

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Tygacil is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in TYGACIL is tigecycline. There are ten drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the tigecycline profile page.

Summary for Tradename: TYGACIL

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: TYGACIL

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, 2005RXYes8,975,242► subscribeY ► subscribe
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RXYesRE40183► subscribeYY ► subscribe
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RXYes8,372,995► subscribeY ► subscribe
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Expired Patents for Tradename: TYGACIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RE40086► subscribe
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, 2005RE40183► subscribe
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Paragraph IV activity for: TYGACIL

Drugname Dosage Strength RLD Submissiondate
tigecyclineFor Injection50 mg per vialTygacil6/15/2009

Non-Orange Book Patents for Tradename: TYGACIL

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
5,494,903 7-substituted-9-substituted amino-6-demethyl-6-deoxytetracyclines► subscribe
RE40086Method for treating bacterial infection with novel 7-substituted-9-substituted amino 6-demethyl-6-deoxytetracyclines► subscribe
5,530,117 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 Tradename: TYGACIL

Country Document Number Estimated Expiration
Czech Republic9202984► subscribe
Japan2013100354► subscribe
Czech Republic284159► 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: TYGACIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C030/2006Ireland► subscribeSPC030/2006: 20071025, EXPIRES: 20170820
279Luxembourg► subscribe91279, EXPIRES: 20170821
90028-6Sweden► subscribePRODUCT NAME: TIGECYKLIN
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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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