Phoslo Gelcaps Patent Expiration

Phoslo Gelcaps is a drug owned by Fresenius Medical Care North America. It is protected by 2 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 30, 2021. Details of Phoslo Gelcaps'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).
US6875445 Encapsulated calcium acetate caplet and a method for inhibiting gastrointestinal phosphorous absorption
Jul, 2021

(3 years ago)

Expired
US6576665 Encapsulated calcium acetate caplet and a method for inhibiting gastrointestinal phosphorous absorption
Apr, 2021

(3 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 Phoslo Gelcaps's patents.

Given below is the list of recent legal activities going on the following patents of Phoslo Gelcaps.

Activity Date Patent Number
Patent litigations
Change in Power of Attorney (May Include Associate POA) 02 Dec, 2011 US6875445 (Litigated)
Email Notification 02 Dec, 2011 US6875445 (Litigated)
Change in Power of Attorney (May Include Associate POA) 01 Dec, 2011 US6576665
Correspondence Address Change 30 Nov, 2011 US6576665
Correspondence Address Change 28 Nov, 2011 US6875445 (Litigated)
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 13 Dec, 2010 US6576665
Mail-Petition Decision - Granted 23 Jan, 2007 US6875445 (Litigated)
Issue Fee Payment Received 24 Jul, 2006 US6875445 (Litigated)
Petition Entered 24 Jul, 2006 US6875445 (Litigated)
Post Issue Communication - Certificate of Correction 25 Nov, 2005 US6576665

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US patents provide insights into the exclusivity only within the United States, but Phoslo Gelcaps 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 Phoslo Gelcaps's family patents as well as insights into ongoing legal events on those patents.

Phoslo Gelcaps's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Phoslo Gelcaps's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 30, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Phoslo Gelcaps Generic API suppliers:

Calcium Acetate is the generic name for the brand Phoslo Gelcaps. 13 different companies have already filed for the generic of Phoslo Gelcaps, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Phoslo Gelcaps's generic

How can I launch a generic of Phoslo Gelcaps before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Phoslo Gelcaps's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Phoslo Gelcaps'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 Phoslo Gelcaps -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
EQ 169 mg calcium 31 May, 2005 1 26 Feb, 2008 03 Apr, 2021 Eligible

Alternative Brands for Phoslo Gelcaps

There are several other brand drugs using the same active ingredient (Calcium Acetate) as Phoslo Gelcaps. 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
Phoslo
Phoslyra


Apart from brand drugs containing the same ingredient, some generics have also been filed for Calcium Acetate, Phoslo Gelcaps's active ingredient. Check the complete list of approved generic manufacturers for Phoslo Gelcaps





About Phoslo Gelcaps

Phoslo Gelcaps is a drug owned by Fresenius Medical Care North America. Phoslo Gelcaps uses Calcium Acetate as an active ingredient. Phoslo Gelcaps was launched by Fresenius Medcl in 2001.

Approval Date:

Phoslo Gelcaps was approved by FDA for market use on 02 April, 2001.

Active Ingredient:

Phoslo Gelcaps uses Calcium Acetate as the active ingredient. Check out other Drugs and Companies using Calcium Acetate ingredient

Dosage:

Phoslo Gelcaps is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
667MG CAPSULE Discontinued ORAL