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Last Updated: September 30, 2022

TEFLARO Drug Patent 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 three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two patent family members in thirty-four 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.

DrugPatentWatch® Generic Entry Outlook for Teflaro

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

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

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

Pharmacology for TEFLARO
Paragraph IV (Patent) Challenges for TEFLARO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TEFLARO for Injection ceftaroline fosamil 400 mg/vial and 600 mg/vial 200327 2 2014-10-29

US Patents and Regulatory Information for TEFLARO

TEFLARO is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting TEFLARO

Phosphonocephem derivatives, process for the preparation of the same, and use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHODS FOR TREATING BACTERIAL INFECTIONS

Cephem compounds useful for the treatment of bacterial infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

Compositions and methods for treating bacterial infections using ceftaroline
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting TEFLARO

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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

Expired US Patents for TEFLARO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-002 Oct 29, 2010 See Plans and Pricing See Plans and Pricing
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 See Plans and Pricing See Plans and Pricing
Allergan TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327-001 Oct 29, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TEFLARO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Ireland Pharmaceuticals Zinforo ceftaroline fosamil EMEA/H/C/002252
Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults:, , , Complicated skin and soft tissue infections (cSSTI), Community-acquired pneumonia (CAP), , , Consideration should be given to official guidance on the appropriate use of antibacterial agents.,
Authorised no no no 2012-08-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TEFLARO

When does loss-of-exclusivity occur for TEFLARO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 53387
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TEFLARO around the world.

Country Patent Number Title Estimated Expiration
Taiwan 473479 See Plans and Pricing
Colombia 6531417 COMPOSICIONES Y M√ČTODOS PARA TRATAR INFECCIONES BACTERIANAS UTILIZANDO CEFTAROLINA See Plans and Pricing
Denmark 1043327 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEFLARO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1043327 C01043327/01 Switzerland See Plans and Pricing PRODUCT NAME: CEFTAROLIN FOSAMIL; REGISTRATION NO/DATE: SWISSMEDIC 62672 29.08.2013
1043327 300568 Netherlands See Plans and Pricing PRODUCT NAME: CEFTAROLINE FOSAMIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/12/785/001 20120823
1043327 CA 2013 00003 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Express Scripts
Colorcon
McKinsey
Medtronic

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 verification 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.