Defitelio is a drug owned by Jazz Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2021 to 2023 out of which none have expired yet. Defitelio's patents have been open to challenges since 30 March, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 22, 2032. Details of Defitelio'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). | |||
| US11085043 | Euglobulin-based method for determining the biological activity of defibrotide |
Jun, 2032
(6 years from now) | Active |
| US11236328 | Euglobulin-based method for determining the biological activity of defibrotide |
Jun, 2032
(6 years from now) | Active |
| US11746348 | Euglobulin-based method for determining the biological activity of defibrotide |
Jun, 2032
(6 years from now) | Active |
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 Defitelio's patents.
Latest Legal Activities on Defitelio's Patents
Given below is the list of recent legal activities going on the following patents of Defitelio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent eGrant | 05 Sep, 2023 | US11746348 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Sep, 2023 | US11746348 |
| Recordation of Patent Grant Mailed Critical | 05 Sep, 2023 | US11746348 |
| Mail Patent eGrant Notification | 05 Sep, 2023 | US11746348 |
| Email Notification Critical | 05 Sep, 2023 | US11746348 |
| Patent eGrant Notification | 05 Sep, 2023 | US11746348 |
| Electronic Review Critical | 18 Aug, 2023 | US11746348 |
| Email Notification Critical | 18 Aug, 2023 | US11746348 |
| Issue Notification Mailed Critical | 16 Aug, 2023 | US11746348 |
| Application Is Considered Ready for Issue Critical | 27 Jul, 2023 | US11746348 |
FDA has granted several exclusivities to Defitelio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Defitelio, 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 Defitelio.
Exclusivity Information
Defitelio holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Defitelio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 30, 2021 |
| Orphan Drug Exclusivity(ODE) | Mar 30, 2023 |
| Orphan Drug Exclusivity(ODE-112) | Mar 30, 2023 |
Several oppositions have been filed on Defitelio'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 Defitelio's generic, the next section provides detailed information on ongoing and past EP oppositions related to Defitelio patents.
Defitelio's Oppositions Filed in EPO
Defitelio has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 29, 2018, by Aechter, Bernd. This opposition was filed on patent number EP12756826A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12756826A | Aug, 2018 | Aechter, Bernd | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Defitelio 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 Defitelio's family patents as well as insights into ongoing legal events on those patents.
Defitelio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Defitelio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 22, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Defitelio Generics:
There are no approved generic versions for Defitelio as of now.
About Defitelio
Defitelio is a drug owned by Jazz Pharmaceuticals Inc. It is used for treating hepatic veno-occlusive disease following hematopoietic stem cell transplantation in adults and pediatric patients. Defitelio uses Defibrotide Sodium as an active ingredient. Defitelio was launched by Jazz Pharms Inc in 2016.
Approval Date:
Defitelio was approved by FDA for market use on 30 March, 2016.
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 Defitelio is 30 March, 2016, its NCE-1 date is estimated to be 30 March, 2020.
Active Ingredient:
Defitelio uses Defibrotide Sodium as the active ingredient. Check out other Drugs and Companies using Defibrotide Sodium ingredient
Treatment:
Defitelio is used for treating hepatic veno-occlusive disease following hematopoietic stem cell transplantation in adults and pediatric patients.
Dosage:
Defitelio is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG/2.5ML (80MG/ML) | SOLUTION | Prescription | INTRAVENOUS |