Firmagon is a drug owned by Ferring Pharmaceuticals Inc. It is protected by 8 US drug patents filed from 2013 to 2023. Out of these, 7 drug patents are active and 1 has expired. Firmagon's patents have been open to challenges since 24 December, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 27, 2032. Details of Firmagon'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). | |||
| US9415085 | Method of treating prostate cancer with GnRH antagonist |
Apr, 2032
(6 years from now) | Active |
| US10695398 | Method of treating prostate cancer with GnRH antagonist |
Apr, 2032
(6 years from now) | Active |
| US11766468 | Method of treating prostate cancer with GnRH antagonist |
Apr, 2032
(6 years from now) | Active |
| US11826397 | Method of treating prostate cancer with GnRH antagonist |
Apr, 2032
(6 years from now) | Active |
| US10973870 | Methods of treating prostate cancer with GnRH antagonist |
Feb, 2029
(3 years from now) | Active |
| US9579359 | Method of treating prostate cancer with GnRH antagonist |
Feb, 2029
(3 years from now) | Active |
| US10729739 | Methods of treating prostate cancer with GnRH antagonist |
Feb, 2029
(3 years from now) | Active |
| US5925730 | GnRH antagonists |
May, 2021
(3 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 Firmagon's patents.
Latest Legal Activities on Firmagon's Patents
Given below is the list of recent legal activities going on the following patents of Firmagon.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Feb, 2024 | US9415085 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Jan, 2024 | US10729739 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Dec, 2023 | US10695398 |
| Email Notification Critical | 29 Nov, 2023 | US11826397 |
| Mail Patent eGrant Notification | 28 Nov, 2023 | US11826397 |
| Recordation of Patent eGrant | 28 Nov, 2023 | US11826397 |
| Patent eGrant Notification | 28 Nov, 2023 | US11826397 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Nov, 2023 | US11826397 |
| Recordation of Patent Grant Mailed Critical | 28 Nov, 2023 | US11826397 |
| Email Notification Critical | 09 Nov, 2023 | US11826397 |
FDA has granted several exclusivities to Firmagon. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Firmagon, 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 Firmagon.
Exclusivity Information
Firmagon holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Firmagon's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 24, 2013 |
Several oppositions have been filed on Firmagon's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Firmagon's generic, the next section provides detailed information on ongoing and past EP oppositions related to Firmagon patents.
Firmagon's Oppositions Filed in EPO
Firmagon has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 23, 2015, by Generics (Uk) Ltd (Trading As Mylan). This opposition was filed on patent number EP09711390A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP13168404A | Dec, 2015 | Generics [UK] Ltd (trading as Mylan) | Revoked |
| EP13168404A | Dec, 2015 | Fresenius Kabi Deutschland GmbH | Revoked |
| EP12165896A | Sep, 2015 | Fresenius Kabi Deutschland GmbH | Revoked |
| EP12165896A | Sep, 2015 | Generics [UK] Limited (trading as Mylan) | Revoked |
| EP09711390A | Jan, 2015 | Generics (UK) Ltd (trading as Mylan) | Revoked |
US patents provide insights into the exclusivity only within the United States, but Firmagon 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 Firmagon's family patents as well as insights into ongoing legal events on those patents.
Firmagon's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Firmagon's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 27, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Firmagon Generics:
There are no approved generic versions for Firmagon as of now.
How can I launch a generic of Firmagon before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Firmagon's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Firmagon'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 Firmagon -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 80 mg/vial and 120 mg/vial | 20 Dec, 2019 | 1 | 27 Apr, 2032 |
About Firmagon
Firmagon is a drug owned by Ferring Pharmaceuticals Inc. It is used for managing advanced prostate cancer and reducing side effects associated with GnRH agonist therapy. Firmagon uses Degarelix Acetate as an active ingredient. Firmagon was launched by Ferring in 2008.
Approval Date:
Firmagon was approved by FDA for market use on 24 December, 2008.
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 Firmagon is 24 December, 2008, its NCE-1 date is estimated to be 24 December, 2012.
Active Ingredient:
Firmagon uses Degarelix Acetate as the active ingredient. Check out other Drugs and Companies using Degarelix Acetate ingredient
Treatment:
Firmagon is used for managing advanced prostate cancer and reducing side effects associated with GnRH agonist therapy.
Dosage:
Firmagon is available in powder form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 120MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |
| EQ 80MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |