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Last Updated: March 19, 2024

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 freedom to operate?

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.

Recent Clinical Trials for prednisolone sodium phosphate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of OuluPhase 4
New England Retina AssociatesPhase 4
Ocular TherapeutixPhase 4

See all prednisolone sodium phosphate clinical trials

Pharmacology 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Edenbridge Pharms PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 203559-004 Feb 6, 2023 AA RX 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
Alcon Pharms Ltd PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 081044-001 Oct 24, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alcon Pharms Ltd PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 081043-001 Oct 24, 1991 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 021959-002 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
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 021959-002 Jun 1, 2006 ⤷  Try a Trial ⤷  Try a Trial
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 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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