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
|
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
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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 Generic API suppliers:
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 |