Firazyr is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Firazyr's patents have been open to challenges since 26 August, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 25, 2018. Details of Firazyr'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). | |||
| US5648333 | Peptides having bradykinin antagonist action |
Jul, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Firazyr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Firazyr, 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 Firazyr.
Exclusivity Information
Firazyr holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Firazyr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 25, 2016 |
| Orphan Drug Exclusivity(ODE) | Aug 25, 2018 |
| Orphan Drug Exclusivity(ODE-14) | Aug 25, 2018 |
US patents provide insights into the exclusivity only within the United States, but Firazyr 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 Firazyr's family patents as well as insights into ongoing legal events on those patents.
Firazyr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Firazyr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 25, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Firazyr Generic API suppliers:
Icatibant Acetate is the generic name for the brand Firazyr. 10 different companies have already filed for the generic of Firazyr, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Firazyr's generic
How can I launch a generic of Firazyr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Firazyr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Firazyr'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 Firazyr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/mL | 25 Aug, 2015 | 2 | 15 Jul, 2019 | Extinguished |
About Firazyr
Firazyr is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating acute attacks of hereditary angioedema by antagonizing bradykinin receptor. Firazyr uses Icatibant Acetate as an active ingredient. Firazyr was launched by Takeda Pharms Usa in 2011.
Approval Date:
Firazyr was approved by FDA for market use on 25 August, 2011.
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 Firazyr is 25 August, 2011, its NCE-1 date is estimated to be 26 August, 2015.
Active Ingredient:
Firazyr uses Icatibant Acetate as the active ingredient. Check out other Drugs and Companies using Icatibant Acetate ingredient
Treatment:
Firazyr is used for treating acute attacks of hereditary angioedema by antagonizing bradykinin receptor.
Dosage:
Firazyr is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | INJECTABLE | Prescription | SUBCUTANEOUS |