ORAPRED ODT Drug Patent Profile
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Which patents cover Orapred Odt, and what generic alternatives are available?
Orapred Odt is a drug marketed by Concordia Pharms Inc and is included in one NDA.
The generic ingredient in ORAPRED ODT is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Orapred Odt
A generic version of ORAPRED ODT was approved as prednisolone sodium phosphate by BAUSCH AND LOMB on July 29th, 1994.
Summary for ORAPRED ODT
See drug prices for ORAPRED ODT
Recent Clinical Trials for ORAPRED ODT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chulalongkorn University | N/A |
| University of Florida | Phase 4 |
| Stanford University | Phase 4 |
Pharmacology for ORAPRED ODT
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ORAPRED ODT
Paragraph IV (Patent) Challenges for ORAPRED ODT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ORAPRED ODT | Orally Disintegrating Tablets | prednisolone sodium phosphate | 10 mg, 15 mg and 30 mg | 021959 | 1 | 2010-07-22 |
US Patents and Regulatory Information for ORAPRED ODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-001 | Jun 1, 2006 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-002 | Jun 1, 2006 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-003 | Jun 1, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ORAPRED ODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-003 | Jun 1, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-001 | Jun 1, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-002 | Jun 1, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-003 | Jun 1, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ORAPRED ODT
See the table below for patents covering ORAPRED ODT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2008001726 | RAPIDLY DISSOLVING ROBUST DOSAGE FORM | ⤷ Try a Trial |
| Spain | 2601855 | ⤷ Try a Trial | |
| Denmark | 2266538 | ⤷ Try a Trial | |
| Australia | 1922000 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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