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Last Updated: November 2, 2024

PREDNISOLONE SODIUM PHOSPHATE Drug Patent Profile


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Which patents cover Prednisolone Sodium Phosphate, and what generic alternatives are available?

Prednisolone Sodium Phosphate is a drug marketed by Watson Labs, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Chartwell Rx, Edenbridge Pharms, Endo Operations, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, Xttrium Labs Inc, and Rising. and is included in thirty NDAs.

The generic ingredient in PREDNISOLONE SODIUM PHOSPHATE is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prednisolone Sodium Phosphate

A generic version of PREDNISOLONE SODIUM PHOSPHATE was approved as prednisolone sodium phosphate by BAUSCH AND LOMB on July 29th, 1994.

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Drug patent expirations by year for PREDNISOLONE SODIUM PHOSPHATE
Recent Clinical Trials for PREDNISOLONE SODIUM PHOSPHATE

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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
We Pharms PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 075181-001 Dec 23, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharm Assoc PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 078988-001 Jun 9, 2008 AA RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Xttrium Labs Inc PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 076895-001 Oct 4, 2004 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
Watson Labs PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate INJECTABLE;INJECTION 080517-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Edenbridge Pharms PREDNISOLONE SODIUM PHOSPHATE prednisolone sodium phosphate SOLUTION;ORAL 203559-002 Dec 20, 2016 AA RX 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

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