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. Teflaro's patents have been open to challenges since 29 October, 2014. 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8247400 | Cephem compounds useful for the treatment of bacterial infections |
Feb, 2031
(5 years from now) | Active |
| US9629861 | Compositions and methods for treating bacterial infections using ceftaroline |
Sep, 2030
(5 years from now) | Active |
| US6906055 | Phosphonocephem compound |
Dec, 2021
(3 years ago) |
Expired
|
| US7419973 | Phosphonocephem compound |
Dec, 2021
(3 years ago) |
Expired
|
| US6417175 | Phosphonocephem derivatives, process for the preparation of the same, and use thereof |
Dec, 2018
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Teflaro's patents.
Latest Legal Activities on Teflaro's Patents
Given below is the list of recent legal activities going on the following patents of Teflaro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2024 | US8247400 (Litigated) |
| Electronic Review Critical | 27 Jun, 2023 | US7419973 |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Jun, 2023 | US7419973 |
| Email Notification Critical | 27 Jun, 2023 | US7419973 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Oct, 2020 | US9629861 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Feb, 2020 | US8247400 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Feb, 2020 | US7419973 |
| Mail Pub Notice re 312 amendment | 19 Jun, 2017 | US9629861 |
| Post Issue Communication - Certificate of Correction | 15 Jun, 2017 | US9629861 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 15 Jun, 2017 | US9629861 |
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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
Alternative Brands for Teflaro
Teflaro which is used for treating bacterial infections., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp |
| |||||
| Cubist Pharms Llc |
| |||||
| Cumberland |
| |||||
| Hikma |
| |||||
| Lg Chem Ltd |
| |||||
| Pfizer |
| |||||
| Pf Prism Cv |
| |||||
| Rempex |
| |||||
| Shionogi Inc |
| |||||
| Wyeth Pharms |
| |||||
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.
Approval Date:
Teflaro was approved by FDA for market use on 29 October, 2010.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |