Renagel is a drug owned by Genzyme Corp. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 18, 2020. Details of Renagel'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). | |||
| US6733780 | Direct compression polymer tablet core |
Oct, 2020
(4 years ago) |
Expired
|
| 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
|
| US7459151 | 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
|
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 Renagel's patents.
Latest Legal Activities on Renagel's Patents
Given below is the list of recent legal activities going on the following patents of Renagel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 May, 2020 | US7459151 |
| Expire Patent Critical | 18 Apr, 2014 | US7014846 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Dec, 2008 | US7459151 |
| Recordation of Patent Grant Mailed Critical | 02 Dec, 2008 | US7459151 |
| Issue Notification Mailed Critical | 12 Nov, 2008 | US7459151 |
| Application Is Considered Ready for Issue Critical | 29 Oct, 2008 | US7459151 |
| Dispatch to FDC | 29 Oct, 2008 | US7459151 |
| Issue Fee Payment Received Critical | 28 Oct, 2008 | US7459151 |
| Issue Fee Payment Verified Critical | 28 Oct, 2008 | US7459151 |
| Pubs Case Remand to TC Critical | 09 Sep, 2008 | US7459151 |
US patents provide insights into the exclusivity only within the United States, but Renagel 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 Renagel's family patents as well as insights into ongoing legal events on those patents.
Renagel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Renagel's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 18, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Renagel Generic API suppliers:
Sevelamer Hydrochloride is the generic name for the brand Renagel. 5 different companies have already filed for the generic of Renagel, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Renagel's generic
How can I launch a generic of Renagel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Renagel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Renagel'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 Renagel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 400 mg and 800 mg | 22 May, 2008 | 1 | 18 Oct, 2020 | Extinguished |
Alternative Brands for Renagel
Renagel which is used for managing hyperphosphatemia in 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.
About Renagel
Renagel is a drug owned by Genzyme Corp. It is used for managing hyperphosphatemia in chronic kidney disease. Renagel uses Sevelamer Hydrochloride as an active ingredient. Renagel was launched by Genzyme in 2000.
Approval Date:
Renagel was approved by FDA for market use on 12 July, 2000.
Active Ingredient:
Renagel uses Sevelamer Hydrochloride as the active ingredient. Check out other Drugs and Companies using Sevelamer Hydrochloride ingredient
Treatment:
Renagel is used for managing hyperphosphatemia in chronic kidney disease.
Dosage:
Renagel is available in the following dosage forms - tablet form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 800MG | TABLET | Prescription | ORAL |
| 400MG | TABLET | Prescription | ORAL |
| 403MG | CAPSULE | Discontinued | ORAL |