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TEFLARO Drug Profile

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Teflaro is a drug marketed by Cerexa and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in fifteen countries.

The generic ingredient in TEFLARO is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.

Summary for Tradename: TEFLARO

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: TEFLARO

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cerexa
TEFLARO
ceftaroline fosamil
POWDER;IV (INFUSION)200327-001Oct 29, 2010RXNo8,247,400► subscribeY ► subscribe
Cerexa
TEFLARO
ceftaroline fosamil
POWDER;IV (INFUSION)200327-001Oct 29, 2010RXNo7,419,973► subscribeY ► subscribe
Cerexa
TEFLARO
ceftaroline fosamil
POWDER;IV (INFUSION)200327-002Oct 29, 2010RXYes► subscribe► subscribe
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Paragraph IV activity for: TEFLARO

Drugname Dosage Strength RLD Submissiondate
ceftaroline fosamilInjection400 mg/vial and 600 mg/vialTeflaro10/29/2014

International Patent Family for Tradename: TEFLARO

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9932497► subscribe
Germany69840796► subscribe
European Patent Office2080765► 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: TEFLARO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1043327/01Switzerland► subscribePRODUCT NAME: CEFTAROLIN FOSAMIL; REGISTRATION NO/DATE: SWISSMEDIC 62672 29.08.2013
90003-0Sweden► subscribePRODUCT NAME: CEFTAROLINFOSAMIL; REG. NO/DATE: EU/1/12/785/001 20120823
00568Netherlands► subscribePRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 00120823
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