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Last Updated: June 21, 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
Huro Biotech Joint Stock CompanyN/A
Vietstar Biomedical ResearchN/A
University of OuluPhase 4

See all prednisolone sodium phosphate clinical trials

Pharmacology for prednisolone sodium phosphate
Anatomical Therapeutic Chemical (ATC) Classes for prednisolone sodium phosphate
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A06AD Osmotically acting laxatives
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A06AG Enemas
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05XA Electrolyte solutions
B05X I.V. SOLUTION ADDITIVES
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
V03AG Drugs for treatment of hypercalcemia
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various
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
Amneal Pharms PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 078345-001 Mar 10, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alcon Pharms Ltd PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 081044-001 Oct 24, 1991 DISCN No No ⤷  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
Sola Barnes Hind PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 084168-001 Approved Prior to Jan 1, 1982 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
Pharmafair PREDAIR FORTE prednisolone sodium phosphate SOLUTION/DROPS;OPHTHALMIC 088165-001 Mar 28, 1983 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

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 021959-001 Jun 1, 2006 ⤷  Sign Up ⤷  Sign Up
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006 ⤷  Sign Up ⤷  Sign Up
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006 ⤷  Sign Up ⤷  Sign Up
Seton Pharm PEDIAPRED prednisolone sodium phosphate SOLUTION;ORAL 019157-001 May 28, 1986 ⤷  Sign Up ⤷  Sign Up
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-001 Jun 1, 2006 ⤷  Sign Up ⤷  Sign Up
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 Jun 1, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.