Teflaro Patent Expiration

Teflaro is a drug owned by Abbvie Inc. It is protected by 5 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 10, 2031. Details of Teflaro's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6417175 Phosphonocephem derivatives, process for the preparation of the same, and use thereof
Dec, 2018

(5 years ago)

Expired
US6906055 Phosphonocephem compound
Dec, 2021

(2 years ago)

Expired
US7419973 Phosphonocephem compound
Dec, 2021

(2 years ago)

Expired
US9629861 Compositions and methods for treating bacterial infections using ceftaroline
Sep, 2030

(6 years from now)

Active
US8247400 Cephem compounds useful for the treatment of bacterial infections
Feb, 2031

(6 years from now)

Active


FDA has granted several exclusivities to Teflaro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Teflaro, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Teflaro.

Exclusivity Information

Teflaro holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Teflaro's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 29, 2015
New Patient Population(NPP) Sep 13, 2022

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US patents provide insights into the exclusivity only within the United States, but Teflaro is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Teflaro's family patents as well as insights into ongoing legal events on those patents.

Teflaro's family patents

Teflaro has patent protection in a total of 23 countries. It's US patent count contributes only to 22.9% of its total global patent coverage. 13 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Teflaro.

Family Patents

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Generic Launch

Generic Release Date:

Teflaro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 10, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Teflaro Generics:

Ceftaroline Fosamil is the generic name for the brand Teflaro. 1 company has already filed for the generic of Teflaro. Check out the entire list of companies who have already received approval for Teflaro's generic

How can I launch a generic of Teflaro before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Teflaro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Teflaro's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Teflaro -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
400 mg/vial and 600 mg/vial 29 Oct, 2014 2 21 Sep, 2021 10 Feb, 2031 Deferred




About Teflaro

Teflaro is a drug owned by Abbvie Inc. It is used for treating bacterial infections. Teflaro uses Ceftaroline Fosamil as an active ingredient. Teflaro was launched by Abbvie in 2010.

Market Authorisation Date:

Teflaro was approved by FDA for market use on 29 October, 2010.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Teflaro is 29 October, 2010, its NCE-1 date is estimated to be 29 October, 2014

Active Ingredient:

Teflaro uses Ceftaroline Fosamil as the active ingredient. Check out other Drugs and Companies using Ceftaroline Fosamil ingredient

Treatment:

Teflaro is used for treating bacterial infections.

Dosage:

Teflaro is available in powder form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
600MG/VIAL POWDER Prescription INTRAVENOUS
400MG/VIAL POWDER Prescription INTRAVENOUS