PREDNISOLONE SODIUM PHOSPHATE - Generic Drug Details

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
New England Retina Associates	Phase 4
Ocular Therapeutix	Phase 4

See all PREDNISOLONE SODIUM PHOSPHATE clinical trials

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
Epic Pharma Llc	SULSTER	prednisolone sodium phosphate; sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	074511-001	Jul 30, 1996		DISCN	No	No
Bausch	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	075250-001	Jul 12, 2002		DISCN	No	No
Amneal Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	078345-001	Mar 10, 2009		DISCN	No	No
Pharmafair	PREDAIR FORTE	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	088165-001	Mar 28, 1983		DISCN	No	No
Schering	METRETON	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	083834-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bausch And Lomb	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate; sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	074449-001	Dec 29, 1995		RX	No	Yes

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
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006
Seton Pharm	PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157-001	May 28, 1986
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-003	Jun 1, 2006
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-001	Jun 1, 2006