Prednisolone acetate - Generic Drug Details

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What are the generic drug sources for prednisolone acetate and what is the scope of freedom to operate?

Prednisolone acetate is the generic ingredient in eighteen branded drugs marketed by Schering, Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, Pfizer, Harrow Eye, Sandoz, Abbvie, Lupin Ltd, Taro, Allergan, Alcon, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Prednisolone acetate has eleven patent family members in nine countries.

There are eighteen drug master file entries for prednisolone acetate. Nine suppliers are listed for this compound.

Summary for prednisolone acetate

International Patents:	11
US Patents:	1
Tradenames:	18
Applicants:	16
NDAs:	28
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	106
Patent Applications:	6,160
Drug Prices:	Drug price trends for prednisolone acetate
Drug Sales Revenues:	Drug sales revenues for prednisolone acetate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for prednisolone acetate
What excipients (inactive ingredients) are in prednisolone acetate?	prednisolone acetate excipients list
DailyMed Link:	prednisolone acetate at DailyMed

See drug prices for prednisolone acetate

Drug Sales Revenue Trends for prednisolone acetate

See drug sales revenues for prednisolone acetate

Recent Clinical Trials for prednisolone acetate

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

Sponsor	Phase
Baoping XU	Phase 4
Wyse Eyecare	Phase 4
Salvat	Phase 3

See all prednisolone acetate clinical trials

Pharmacology for prednisolone acetate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for prednisolone acetate

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

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

US Patents and Regulatory Information for prednisolone acetate

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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
Watson Labs	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	083767-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	083654-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	083032-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PREDNISOLONE ACETATE	prednisolone acetate	INJECTABLE;INJECTION	083398-001	Approved Prior to Jan 1, 1982		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 acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	⤷ Sign Up	⤷ Sign Up
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	⤷ Sign Up	⤷ Sign Up
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	⤷ Sign Up	⤷ Sign Up
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for prednisolone acetate

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Country	Patent Number	Title	Estimated Expiration
South Korea	20080044245	ORAL SUSPENSION OF PREDNISOLONE ACETATE	⤷ Sign Up
Japan	2013014634	ORAL SUSPENSION OF PREDNISOLONE ACETATE	⤷ Sign Up
Japan	2009503097		⤷ Sign Up
Canada	2616112	SUSPENSION ORALE D'ACETATE DE PREDNISOLONE (ORAL SUSPENSION OF PREDNISOLONE ACETATE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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