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.
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Questions you can ask:
- What is the 5 year forecast for ORAPRED ODT?
- What are the global sales for ORAPRED ODT?
- What is Average Wholesale Price for ORAPRED ODT?
Summary 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 |
Winston Chamberlain, MD, PhD | Phase 4 |
Pharmacology for ORAPRED ODT
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-002 | Jun 1, 2006 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-003 | Jun 1, 2006 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-001 | Jun 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-002 | Jun 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | ORAPRED ODT | prednisolone sodium phosphate | TABLET, ORALLY DISINTEGRATING;ORAL | 021959-003 | Jun 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>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 | 2002530322 | ⤷ Sign Up | |
Spain | 2525720 | ⤷ Sign Up | |
Japan | 2012162558 | RAPIDLY DISSOLVING ROBUST DOSAGE FORM | ⤷ Sign Up |
Hong Kong | 1137654 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |