You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 28, 2024

PREDNISOLONE SODIUM PHOSPHATE - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
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
Novartis	INFLAMASE MILD	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	080751-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate; sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	073630-001	May 27, 1993		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sola Barnes Hind	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	084171-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	202179-003	Apr 10, 2013		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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Concordia Pharms Inc	ORAPRED ODT	prednisolone sodium phosphate	TABLET, ORALLY DISINTEGRATING;ORAL	021959-002	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	021959-001	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
Seton Pharm	PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157-001	May 28, 1986	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.