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Last Updated: January 23, 2020

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TEFLARO Drug Profile

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When do Teflaro patents expire, and what generic alternatives are available?

Teflaro is a drug marketed by Allergan and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-seven patent family members in thirty-two 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.

US ANDA Litigation and Generic Entry Outlook for Teflaro

Teflaro was eligible for patent challenges on October 29, 2014.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 10, 2031. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TEFLARO
Drug Prices for TEFLARO

See drug prices for TEFLARO

Generic Entry Opportunity Date for TEFLARO
Generic Entry Date for TEFLARO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TEFLARO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Olayemi Osiyemi MDPhase 4
Basim AsmarPhase 1
Sharp HealthCarePhase 4

See all TEFLARO clinical trials

Recent Litigation for TEFLARO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Forest Laboratories, LLC v. Apotex Inc.2016-04-15
Forest Laboratories LLC v. Apotex Corp.2015-01-05
SI Liquidation Co.2010-08-24

See all TEFLARO litigation

Pharmacology for TEFLARO
Synonyms for TEFLARO
(6R,7R)-7-((Z)-2-(ethoxyimino)-2-(5-(phosphonoamino)-1,2,4-thiadiazol-3-yl)acetamido)-3-((4-(1-methylpyridin-1-ium-4-yl)thiazol-2-yl)thio)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxyla
(6R,7R)-7-({(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetyl}amino)-3-{[4-(1-methylpyridinium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate acetate
400827-46-5
595568-96-0
AKOS027326632
Ceftaroline fosamil
Ceftaroline fosamil (USAN/INN)
Ceftaroline fosamil acetate
ceftaroline fosamil acetate (anhydrous)
Ceftaroline fosamil acetate anhydrous
Ceftaroline fosamil acetate hydrate
Ceftaroline fosamil acetate monohydrate
CHEBI:70714
CHEBI:70715
CHEMBL3544973
CS-2823
D08884
DSP-5990
DTXSID50193133
EZ9W6O5S09
HY-14737
PPI 0903
Pyridinium, 4-(2-(((6R,7R)-2-carboxy-7-(((2Z)-(ethoxyimino)(5-(phosphonoamino)-1,2,4-thiadiazol-3-yl)acetyl)amino)-8-oxo-5-thia-1- azabicyclo(4.2.0)oct-2-en-3-yl)thio)-4-thiazolyl)-1-methyl-, acetate
TAK 599
te compound with acetic acid (1:1)
Teflaro (TN)
UNII-EZ9W6O5S09
Zinforo
Paragraph IV (Patent) Challenges for TEFLARO
Tradename Dosage Ingredient NDA Submissiondate
TEFLARO POWDER;INTRAVENOUS ceftaroline fosamil 200327 2014-10-29

US Patents and Regulatory Information for TEFLARO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TEFLARO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1043327 2013/001 Ireland   Start Trial PRODUCT NAME: CEFTAROLINE FOSAMIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327 C300568 Netherlands   Start Trial PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 00120823
1043327 1390003-0 Sweden   Start Trial PRODUCT NAME: CEFTAROLINFOSAMIL; REG. NO/DATE: EU/1/12/785/001 20120823
1043327 422 Finland   Start Trial
1043327 13C0008 France   Start Trial PRODUCT NAME: CEFTAROLINE FOSAMIL, SES ESTERS OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Baxter
McKesson
Boehringer Ingelheim
Moodys

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