Renvela is a drug owned by Genzyme Corp. It is protected by 7 US drug patents filed from 2013 to 2016. Out of these, 1 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 06, 2030. Details of Renvela'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). | |||
| US9095509 | Sachet formulation for amine polymers |
Dec, 2030
(5 years from now) | Active |
| US5667775 | Phosphate-binding polymers for oral administration |
Sep, 2014
(10 years ago) |
Expired
|
| US7014846 | Phosphate-binding polymers for oral administration |
Aug, 2013
(11 years ago) |
Expired
|
| US5496545 | Phosphate-binding polymers for oral administration |
Aug, 2013
(11 years ago) |
Expired
|
| US7459151 | Phosphate-binding polymers for oral administration |
Aug, 2013
(11 years ago) |
Expired
|
| US6858203 | Method of making phosphate-binding polymers for oral administration |
Aug, 2013
(11 years ago) |
Expired
|
| US6509013 | Method of making phosphate-binding polymers for oral administration |
Aug, 2013
(11 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 Renvela's patents.
Latest Legal Activities on Renvela's Patents
Given below is the list of recent legal activities going on the following patents of Renvela.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Jan, 2023 | US9095509 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2023 | US7985418 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 May, 2020 | US7459151 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Jan, 2019 | US9095509 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jan, 2019 | US7985418 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Aug, 2015 | US9095509 |
| Recordation of Patent Grant Mailed Critical | 04 Aug, 2015 | US9095509 |
| Issue Notification Mailed Critical | 15 Jul, 2015 | US9095509 |
| Application Is Considered Ready for Issue Critical | 07 Jul, 2015 | US9095509 |
| Dispatch to FDC | 07 Jul, 2015 | US9095509 |
FDA has granted several exclusivities to Renvela. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Renvela, 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 Renvela.
Exclusivity Information
Renvela holds 2 exclusivities. All of its exclusivities have expired in 2019. Details of Renvela's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Aug 12, 2012 |
| New Patient Population(NPP) | Nov 25, 2019 |
Several oppositions have been filed on Renvela'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 Renvela's generic, the next section provides detailed information on ongoing and past EP oppositions related to Renvela patents.
Renvela's Oppositions Filed in EPO
Renvela has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 20, 2016, by Alpex Pharma S.A.. This opposition was filed on patent number EP06824928A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06824928A | Jul, 2016 | Alpex Pharma S.A. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Renvela 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 Renvela's family patents as well as insights into ongoing legal events on those patents.
Renvela's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Renvela's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 06, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Renvela Generic API suppliers:
Sevelamer Carbonate is the generic name for the brand Renvela. 17 different companies have already filed for the generic of Renvela, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Renvela's generic
How can I launch a generic of Renvela before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Renvela's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Renvela'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 Renvela -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.8 g/packet and 2.4 g/packet | 30 Dec, 2009 | 1 | 16 Sep, 2014 | Extinguished | |
| 800 mg | 04 Dec, 2008 | 1 | 23 Oct, 2017 | 16 Sep, 2014 | Extinguished |
Alternative Brands for Renvela
Renvela which is used for managing high levels of phosphate in the blood, often in patients with chronic kidney disease., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Genzyme |
| |||
About Renvela
Renvela is a drug owned by Genzyme Corp. It is used for managing high levels of phosphate in the blood, often in patients with chronic kidney disease. Renvela uses Sevelamer Carbonate as an active ingredient. Renvela was launched by Genzyme in 2009.
Approval Date:
Renvela was approved by FDA for market use on 18 February, 2009.
Active Ingredient:
Renvela uses Sevelamer Carbonate as the active ingredient. Check out other Drugs and Companies using Sevelamer Carbonate ingredient
Treatment:
Renvela is used for managing high levels of phosphate in the blood, often in patients with chronic kidney disease.
Dosage:
Renvela is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 800MG/PACKET | FOR SUSPENSION | Prescription | ORAL |
| 2.4GM/PACKET | FOR SUSPENSION | Prescription | ORAL |
Renvela is a drug owned by Sanofi Genzyme. It is protected by 7 US drug patents filed in 2013. Out of these, 1 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 27, 2025. Details of Renvela'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). | |||
| US7985418 | Aliphatic amine polymer salts for tableting |
Oct, 2025
(10 months from now) | Active |
| US5667775 | Phosphate-binding polymers for oral administration |
Sep, 2014
(10 years ago) |
Expired
|
| US6509013 | Method of making phosphate-binding polymers for oral administration |
Aug, 2013
(11 years ago) |
Expired
|
| US5496545 | Phosphate-binding polymers for oral administration |
Aug, 2013
(11 years ago) |
Expired
|
| US6858203 | Method of making phosphate-binding polymers for oral administration |
Aug, 2013
(11 years ago) |
Expired
|
| US7014846 | Phosphate-binding polymers for oral administration |
Aug, 2013
(11 years ago) |
Expired
|
| US7459151 | Phosphate-binding polymers for oral administration |
Aug, 2013
(11 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 Renvela's patents.
Latest Legal Activities on Renvela's Patents
Given below is the list of recent legal activities going on the following patents of Renvela.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Jan, 2023 | US9095509 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jan, 2023 | US7985418 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 May, 2020 | US7459151 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Jan, 2019 | US9095509 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jan, 2019 | US7985418 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Aug, 2015 | US9095509 |
| Recordation of Patent Grant Mailed Critical | 04 Aug, 2015 | US9095509 |
| Issue Notification Mailed Critical | 15 Jul, 2015 | US9095509 |
| Application Is Considered Ready for Issue Critical | 07 Jul, 2015 | US9095509 |
| Dispatch to FDC | 07 Jul, 2015 | US9095509 |
FDA has granted several exclusivities to Renvela. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Renvela, 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 Renvela.
Exclusivity Information
Renvela holds 2 exclusivities. All of its exclusivities have expired in 2019. Details of Renvela's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Aug 12, 2012 |
| New Patient Population(NPP) | Nov 25, 2019 |
US patents provide insights into the exclusivity only within the United States, but Renvela 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 Renvela's family patents as well as insights into ongoing legal events on those patents.
Renvela's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Renvela's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 27, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Renvela Generic API suppliers:
Sevelamer Carbonate is the generic name for the brand Renvela. 17 different companies have already filed for the generic of Renvela, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Renvela's generic
How can I launch a generic of Renvela before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Renvela's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Renvela'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 Renvela -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.8 g/packet and 2.4 g/packet | 30 Dec, 2009 | 1 | 16 Sep, 2014 | Extinguished | |
| 800 mg | 04 Dec, 2008 | 1 | 23 Oct, 2017 | 16 Sep, 2014 | Extinguished |
Alternative Brands for Renvela
Renvela which is used for managing high levels of phosphate in the blood, often in patients with chronic kidney disease., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Genzyme |
| |||
About Renvela
Renvela is a drug owned by Sanofi Genzyme. It is used for managing high levels of phosphate in the blood, often in patients with chronic kidney disease. Renvela uses Sevelamer Carbonate as an active ingredient. Renvela was launched by Sanofi in 2007.
Approval Date:
Renvela was approved by FDA for market use on 19 October, 2007.
Active Ingredient:
Renvela uses Sevelamer Carbonate as the active ingredient. Check out other Drugs and Companies using Sevelamer Carbonate ingredient
Treatment:
Renvela is used for managing high levels of phosphate in the blood, often in patients with chronic kidney disease.
Dosage:
Renvela is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 800MG | TABLET | Prescription | ORAL |