PREDNISOLONE SODIUM PHOSPHATE Drug Patent Profile
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Which patents cover Prednisolone Sodium Phosphate, and what generic alternatives are available?
Prednisolone Sodium Phosphate is a drug marketed by Watson Labs, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Endo Operations, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, and Rising. and is included in thirty NDAs.
The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE 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 Prednisolone Sodium Phosphate
A generic version of PREDNISOLONE SODIUM PHOSPHATE 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 PREDNISOLONE SODIUM PHOSPHATE?
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Summary for PREDNISOLONE SODIUM PHOSPHATE
| US Patents: | 0 |
| Applicants: | 20 |
| NDAs: | 30 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 10 |
| Patent Applications: | 4,662 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PREDNISOLONE SODIUM PHOSPHATE |
| What excipients (inactive ingredients) are in PREDNISOLONE SODIUM PHOSPHATE? | PREDNISOLONE SODIUM PHOSPHATE excipients list |
| DailyMed Link: | PREDNISOLONE SODIUM PHOSPHATE at DailyMed |
Recent Clinical Trials for PREDNISOLONE SODIUM PHOSPHATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Huro Biotech Joint Stock Company | N/A |
| Vietstar Biomedical Research | N/A |
| University of Oulu | Phase 4 |
Pharmacology for PREDNISOLONE SODIUM PHOSPHATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE SODIUM PHOSPHATE
Paragraph IV (Patent) Challenges for PREDNISOLONE SODIUM PHOSPHATE
| 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 PREDNISOLONE SODIUM PHOSPHATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vintage Pharms | PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 078416-001 | Oct 31, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharm Assoc | PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 078988-001 | Jun 9, 2008 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| We Pharms | PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 075181-001 | Dec 23, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharm Assoc | PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 204962-001 | Mar 11, 2020 | DISCN | No | No | ⤷ 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 |
