Velphoro is a drug owned by Vifor Fresenius Medical Care Renal Pharma France. It is protected by 23 US drug patents filed from 2013 to 2022. Out of these, 22 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 26, 2035. Details of Velphoro's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6174442 | Adsorbent for phosphate from an aqueous medium, production and use of said adsorbent |
Jun, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US11234938 (Pediatric) | Pharmaceutical composition, comprising phosphate binder particles |
May, 2035
(10 years from now) | Active |
|
US11446252 (Pediatric) | Pharmaceutical composition, comprising phosphate binder particles |
May, 2035
(10 years from now) | Active |
|
US10624855 (Pediatric) | Pharmaceutical composition, comprising phosphate binder particles |
May, 2035
(10 years from now) | Active |
| US10624855 | Pharmaceutical composition, comprising phosphate binder particles |
Nov, 2034
(9 years from now) | Active |
| US11446252 | Pharmaceutical composition, comprising phosphate binder particles |
Nov, 2034
(9 years from now) | Active |
| US11234938 | Pharmaceutical composition, comprising phosphate binder particles |
Nov, 2034
(9 years from now) | Active |
|
US9561251 (Pediatric) | Pharmaceutical compositions |
Jul, 2030
(5 years from now) | Active |
| US9561251 | Pharmaceutical compositions |
Jan, 2030
(5 years from now) | Active |
|
US10925897 (Pediatric) | Pharmaceutical compositions |
May, 2029
(4 years from now) | Active |
|
US10933090 (Pediatric) | Pharmaceutical compositions |
May, 2029
(4 years from now) | Active |
|
US10682376 (Pediatric) | Pharmaceutical compositions |
May, 2029
(4 years from now) | Active |
|
US11013761 (Pediatric) | Pharmaceutical compositions |
May, 2029
(4 years from now) | Active |
|
US11013762 (Pediatric) | Pharmaceutical compositions |
May, 2029
(4 years from now) | Active |
|
US10925896 (Pediatric) | Pharmaceutical compositions |
May, 2029
(4 years from now) | Active |
|
US10695367 (Pediatric) | Pharmaceutical compositions |
May, 2029
(4 years from now) | Active |
| US10925896 | Pharmaceutical compositions |
Nov, 2028
(3 years from now) | Active |
| US10682376 | Pharmaceutical compositions |
Nov, 2028
(3 years from now) | Active |
| US11013761 | Pharmaceutical compositions |
Nov, 2028
(3 years from now) | Active |
| US10925897 | Pharmaceutical compositions |
Nov, 2028
(3 years from now) | Active |
| US10933090 | Pharmaceutical compositions |
Nov, 2028
(3 years from now) | Active |
| US11013762 | Pharmaceutical compositions |
Nov, 2028
(3 years from now) | Active |
| US10695367 | Pharmaceutical compositions |
Nov, 2028
(3 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 Velphoro's patents.
Latest Legal Activities on Velphoro's Patents
Given below is the list of recent legal activities going on the following patents of Velphoro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Dec, 2023 | US10695367 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Dec, 2023 | US10682376 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Oct, 2023 | US10624855 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Sep, 2022 | US11446252 |
| Recordation of Patent Grant Mailed Critical | 20 Sep, 2022 | US11446252 |
| Email Notification Critical | 01 Sep, 2022 | US11446252 |
| Issue Notification Mailed Critical | 31 Aug, 2022 | US11446252 |
| Application Is Considered Ready for Issue Critical | 23 Aug, 2022 | US11446252 |
| Dispatch to FDC | 23 Aug, 2022 | US11446252 |
| Issue Fee Payment Received Critical | 12 Aug, 2022 | US11446252 |
FDA has granted several exclusivities to Velphoro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Velphoro, 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 Velphoro.
Exclusivity Information
Velphoro holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Velphoro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 27, 2016 |
| New Patient Population(NPP) | Jul 01, 2027 |
| Pediatric Exclusivity(PED) | Jan 01, 2028 |
Several oppositions have been filed on Velphoro'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 Velphoro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Velphoro patents.
Velphoro's Oppositions Filed in EPO
Velphoro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 28, 2017, by Stada Arzneimittel Ag. This opposition was filed on patent number EP08848615A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08848615A | Sep, 2017 | Interquim S.A. | Revoked |
| EP08848615A | Sep, 2017 | STADA Arzneimittel AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Velphoro 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 Velphoro's family patents as well as insights into ongoing legal events on those patents.
Velphoro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Velphoro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 26, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Velphoro Generic API suppliers:
Ferric Oxyhydroxide is the generic name for the brand Velphoro. 1 company has already filed for the generic of Velphoro. Check out the entire list of companies who have already received approval for Velphoro's generic
Alternative Brands for Velphoro
Velphoro which is used for lowering phosphorus levels in patients., has several other brand drugs using the same active ingredient (Ferric Oxyhydroxide). 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 | |
|---|---|---|
| Am Regent |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ferric Oxyhydroxide, Velphoro's active ingredient. Check the complete list of approved generic manufacturers for Velphoro
About Velphoro
Velphoro is a drug owned by Vifor Fresenius Medical Care Renal Pharma France. It is used for lowering phosphorus levels in patients. Velphoro uses Ferric Oxyhydroxide as an active ingredient. Velphoro was launched by Vifor Fresenius in 2013.
Approval Date:
Velphoro was approved by FDA for market use on 27 November, 2013.
Active Ingredient:
Velphoro uses Ferric Oxyhydroxide as the active ingredient. Check out other Drugs and Companies using Ferric Oxyhydroxide ingredient
Treatment:
Velphoro is used for lowering phosphorus levels in patients.
Dosage:
Velphoro is available in tablet, chewable form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG IRON | TABLET, CHEWABLE | Prescription | ORAL |