PREDNISOLONE SODIUM PHOSPHATE - Generic Drug Details
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What are the generic drug sources for prednisolone sodium phosphate and what is the scope of patent protection?
Prednisolone sodium phosphate
is the generic ingredient in thirteen branded drugs marketed by Merck, Watson Labs, Novartis, Schering, Pharmafair, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Sola Barnes Hind, Concordia Pharms Inc, Seton Pharm, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Vintage, Vintage Pharms, We Pharms, Xttrium Labs Inc, Rising, and Sandoz, and is included in forty-three NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for prednisolone sodium phosphate. Fifteen suppliers are listed for this compound.
Summary for PREDNISOLONE SODIUM PHOSPHATE
US Patents: | 0 |
Tradenames: | 13 |
Applicants: | 27 |
NDAs: | 43 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 9 |
Patent Applications: | 7,298 |
Formulation / Manufacturing: | see details |
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 |
---|---|
University of Oulu | Phase 4 |
Ocular Therapeutix | Phase 4 |
New England Retina Associates | Phase 4 |
Pharmacology for PREDNISOLONE SODIUM PHOSPHATE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharm Assoc | PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 078465-001 | Mar 7, 2008 | AA | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Merck | HYDELTRASOL | prednisolone sodium phosphate | OINTMENT;OPHTHALMIC, OTIC | 011028-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Vintage | PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 079010-001 | May 26, 2009 | DISCN | No | No | ⤷ 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 PREDNISOLONE SODIUM PHOSPHATE
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 | 021959-001 | Jun 1, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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