Orapred Odt Patent Expiration

Orapred Odt is a drug owned by Concordia Pharmaceuticals Inc. It is protected by 3 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 Nov 24, 2019. Details of Orapred Odt'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).
US6740341 Taste masking rapid release coating system
Nov, 2019

(4 years ago)

Expired
US6221392 Rapidly dissolving robust dosage form
Apr, 2018

(6 years ago)

Expired
US6024981 Rapidly dissolving robust dosage form
Apr, 2018

(6 years ago)

Expired

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

Orapred Odt's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Orapred Odt's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 24, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Orapred Odt Generics:

Prednisolone Sodium Phosphate is the generic name for the brand Orapred Odt. 24 different companies have already filed for the generic of Orapred Odt, with Pharm Assoc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Orapred Odt's generic

How can I launch a generic of Orapred Odt before its drug patent expiration? :

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg, 15 mg and 30 mg 22 Jul, 2010 1 10 Apr, 2013 24 Nov, 2019 Eligible





About Orapred Odt

Orapred Odt is a drug owned by Concordia Pharmaceuticals Inc. Orapred Odt uses Prednisolone Sodium Phosphate as an active ingredient. Orapred Odt was launched by Concordia Pharms Inc in 2006.

Approval Date:

Orapred Odt was approved by FDA for market use on 01 June, 2006.

Active Ingredient:

Orapred Odt uses Prednisolone Sodium Phosphate as the active ingredient. Check out other Drugs and Companies using Prednisolone Sodium Phosphate ingredient

Dosage:

Orapred Odt is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 30MG BASE TABLET, ORALLY DISINTEGRATING Prescription ORAL
EQ 15MG BASE TABLET, ORALLY DISINTEGRATING Prescription ORAL
EQ 10MG BASE TABLET, ORALLY DISINTEGRATING Prescription ORAL