Fosrenol is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 5 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 01, 2030. Details of Fosrenol'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). | |||
| US8980327 | Capsule and powder formulations containing lanthanum compounds |
Dec, 2030
(5 years from now) | Active |
| US9023397 | Capsule and powder formulations containing lanthanum compounds |
Dec, 2030
(5 years from now) | Active |
| US7465465 | Pharmaceutical formulation comprising lanthanum compounds |
Aug, 2024
(10 months ago) |
Expired
|
| US7381428 | Stabilized lanthanum carbonate compositions |
Aug, 2024
(10 months ago) |
Expired
|
| US5968976 | Pharmaceutical composition containing selected lanthanum carbonate hydrates |
Oct, 2018
(6 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 Fosrenol's patents.
Latest Legal Activities on Fosrenol's Patents
Given below is the list of recent legal activities going on the following patents of Fosrenol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Oct, 2022 | US9023397 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 May, 2020 | US7465465 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Nov, 2019 | US7381428 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Oct, 2018 | US9023397 |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US9023397 |
| Patent Issue Date Used in PTA Calculation Critical | 05 May, 2015 | US9023397 |
| Recordation of Patent Grant Mailed Critical | 05 May, 2015 | US9023397 |
| Email Notification Critical | 16 Apr, 2015 | US9023397 |
| Issue Notification Mailed Critical | 15 Apr, 2015 | US9023397 |
| Dispatch to FDC | 08 Apr, 2015 | US9023397 |
Several oppositions have been filed on Fosrenol'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 Fosrenol's generic, the next section provides detailed information on ongoing and past EP oppositions related to Fosrenol patents.
Fosrenol's Oppositions Filed in EPO
Fosrenol has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 10, 2010, by Actavis Group Ptc Ehf. This opposition was filed on patent number EP04761727A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14167982A | Mar, 2017 | Natco Pharma Limited | Revoked |
| EP04761727A | Dec, 2010 | Teva Pharmaceutical Industries Ltd. | Opposition rejected |
| EP04761727A | Dec, 2010 | Actavis Group PTC EHF | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Fosrenol 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 Fosrenol's family patents as well as insights into ongoing legal events on those patents.
Fosrenol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fosrenol's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 01, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fosrenol Generic API suppliers:
Lanthanum Carbonate is the generic name for the brand Fosrenol. 4 different companies have already filed for the generic of Fosrenol, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fosrenol's generic
How can I launch a generic of Fosrenol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fosrenol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fosrenol'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 Fosrenol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg, 750 mg and 1000 mg | 27 Oct, 2008 | 3 | 11 Aug, 2017 | 26 Aug, 2024 | Deferred |
| 750 mg and 1000 mg | 25 Nov, 2015 | 1 | 01 Dec, 2030 | Extinguished |
About Fosrenol
Fosrenol is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for lowering serum phosphate levels in patients with end stage renal disease. Fosrenol uses Lanthanum Carbonate as an active ingredient. Fosrenol was launched by Takeda Pharms Usa in 2014.
Approval Date:
Fosrenol was approved by FDA for market use on 24 September, 2014.
Active Ingredient:
Fosrenol uses Lanthanum Carbonate as the active ingredient. Check out other Drugs and Companies using Lanthanum Carbonate ingredient
Treatment:
Fosrenol is used for lowering serum phosphate levels in patients with end stage renal disease.
Dosage:
Fosrenol is available in tablet, chewable form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1GM BASE | TABLET, CHEWABLE | Prescription | ORAL |
| EQ 750MG BASE | TABLET, CHEWABLE | Prescription | ORAL |
| EQ 500MG BASE | TABLET, CHEWABLE | Prescription | ORAL |
| EQ 250MG BASE | TABLET, CHEWABLE | Discontinued | ORAL |