Phoslyra is a drug owned by Fresenius Medical Care North America. It is protected by 3 US drug patents filed from 2013 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 23, 2030. Details of Phoslyra'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). | |||
| US8591938 | Liquid compositions of calcium acetate |
Feb, 2030
(5 years from now) | Active |
| US8592480 | Liquid compositions of calcium acetate |
Jul, 2027
(2 years from now) | Active |
| US9089528 | Liquid compositions of calcium acetate |
Jul, 2027
(2 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 Phoslyra's patents.
Latest Legal Activities on Phoslyra's Patents
Given below is the list of recent legal activities going on the following patents of Phoslyra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 04 Sep, 2023 | US9089528 |
| Maintenance Fee Reminder Mailed Critical | 20 Mar, 2023 | US9089528 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 May, 2021 | US8592480 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 May, 2021 | US8591938 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jan, 2019 | US9089528 |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US9089528 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Jul, 2015 | US9089528 |
| Recordation of Patent Grant Mailed Critical | 28 Jul, 2015 | US9089528 |
| Email Notification Critical | 09 Jul, 2015 | US9089528 |
| Issue Notification Mailed Critical | 08 Jul, 2015 | US9089528 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Phoslyra and ongoing litigations to help you estimate the early arrival of Phoslyra generic.
Phoslyra's Litigations
Phoslyra been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 31, 2011, against patent number US8591938. The petitioner , challenged the validity of this patent, with Stephen C. Tarallo as the respondent. Click below to track the latest information on how companies are challenging Phoslyra's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8591938 | May, 2011 |
Decision
(22 May, 2013) | Stephen C. Tarallo | |
US patents provide insights into the exclusivity only within the United States, but Phoslyra 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 Phoslyra's family patents as well as insights into ongoing legal events on those patents.
Phoslyra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Phoslyra's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 23, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Phoslyra Generic API suppliers:
Calcium Acetate is the generic name for the brand Phoslyra. 13 different companies have already filed for the generic of Phoslyra, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Phoslyra's generic
How can I launch a generic of Phoslyra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Phoslyra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Phoslyra'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 Phoslyra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 667 mg/5 mL | 05 Dec, 2013 | 2 | 23 Feb, 2030 |
Alternative Brands for Phoslyra
Phoslyra which is used for lowering serum phosphorus levels in patients., has several other brand drugs using the same active ingredient (Calcium Acetate). 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 | ||
|---|---|---|---|
| Fresenius Medcl |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Calcium Acetate, Phoslyra's active ingredient. Check the complete list of approved generic manufacturers for Phoslyra
About Phoslyra
Phoslyra is a drug owned by Fresenius Medical Care North America. It is used for lowering serum phosphorus levels in patients. Phoslyra uses Calcium Acetate as an active ingredient. Phoslyra was launched by Fresenius Medcl in 2011.
Approval Date:
Phoslyra was approved by FDA for market use on 18 April, 2011.
Active Ingredient:
Phoslyra uses Calcium Acetate as the active ingredient. Check out other Drugs and Companies using Calcium Acetate ingredient
Treatment:
Phoslyra is used for lowering serum phosphorus levels in patients.
Dosage:
Phoslyra is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 667MG/5ML | SOLUTION | Discontinued | ORAL |