Last Updated: May 10, 2026

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, Hikma, Mission Pharma, Nesher Pharms, Ph Health, Pharm Assoc, Pharmobedient, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, 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. Nineteen 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 29^th, 1994.

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Summary for PREDNISOLONE SODIUM PHOSPHATE

US Patents:	0
Applicants:	20
NDAs:	30
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	10
Patent Applications:	5,450
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

Drug patent expirations by year for PREDNISOLONE SODIUM PHOSPHATE

Recent Clinical Trials for PREDNISOLONE SODIUM PHOSPHATE

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Sponsor	Phase
Vietstar Biomedical Research	N/A
Huro Biotech Joint Stock Company	N/A
University of Oulu	Phase 4

See all PREDNISOLONE SODIUM PHOSPHATE clinical trials

Pharmacology for PREDNISOLONE SODIUM PHOSPHATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharm Assoc	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	078988-001	Jun 9, 2008	AA	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
We Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	075181-001	Dec 23, 2002		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharm Assoc	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	204962-001	Mar 11, 2020		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Watson Labs	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	INJECTABLE;INJECTION	080517-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Edenbridge Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	203559-002	Dec 20, 2016	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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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