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 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, Endo Operations, Hikma, Mission Pharma, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Vintage Pharms, We Pharms, Xttrium Labs Inc, Rising, and Genus, 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:	10
Patent Applications:	7,350
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
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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Glossary

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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
Epic Pharma Llc	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION/DROPS;OPHTHALMIC	083358-002	Approved Prior to Jan 1, 1982		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
Nesher Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	076988-001	May 24, 2005		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
Bausch	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	075250-001	Jul 12, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vintage Pharms	PREDNISOLONE SODIUM PHOSPHATE	prednisolone sodium phosphate	SOLUTION;ORAL	078416-001	Oct 31, 2007		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

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

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