Xofigo is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 2 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 1 has expired. Xofigo's patents have been open to challenges since 15 May, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 23, 2027. Details of Xofigo'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). | |||
| US8791127 | Mucosal bioadhesive slow release carrier for delivering active principles |
Mar, 2027
(2 years from now) | Active |
| US6635234 | Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning |
Jan, 2020
(4 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 Xofigo's patents.
Latest Legal Activities on Xofigo's Patents
Given below is the list of recent legal activities going on the following patents of Xofigo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Dec, 2021 | US8791127 |
| Email Notification Critical | 22 Sep, 2020 | US8791127 |
| Mail O.P. Petition Decision | 22 Sep, 2020 | US8791127 |
| Mail-Petition Decision - Granted | 17 Sep, 2020 | US8791127 |
| Petition Decision - Granted Critical | 16 Sep, 2020 | US8791127 |
| O.P. Petition Decision | 14 Sep, 2020 | US8791127 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 16 Jun, 2020 | US8791127 |
| Change in Power of Attorney (May Include Associate POA) Critical | 15 Jun, 2020 | US8791127 |
| Email Notification Critical | 15 Jun, 2020 | US8791127 |
| Correspondence Address Change Critical | 10 Jun, 2020 | US8791127 |
FDA has granted several exclusivities to Xofigo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xofigo, 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 Xofigo.
Exclusivity Information
Xofigo holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Xofigo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 15, 2018 |
US patents provide insights into the exclusivity only within the United States, but Xofigo 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 Xofigo's family patents as well as insights into ongoing legal events on those patents.
Xofigo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xofigo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 23, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xofigo Generics:
There are no approved generic versions for Xofigo as of now.
About Xofigo
Xofigo is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for managing bone metastases. Xofigo uses Radium Ra-223 Dichloride as an active ingredient. Xofigo was launched by Bayer Hlthcare in 2013.
Approval Date:
Xofigo was approved by FDA for market use on 15 May, 2013.
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 Xofigo is 15 May, 2013, its NCE-1 date is estimated to be 15 May, 2017.
Active Ingredient:
Xofigo uses Radium Ra-223 Dichloride as the active ingredient. Check out other Drugs and Companies using Radium Ra-223 Dichloride ingredient
Treatment:
Xofigo is used for managing bone metastases.
Dosage:
Xofigo is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 162mCi/6ML (27mCi/ML) | SOLUTION | Prescription | INTRAVENOUS |