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Prednisolone acetate - Generic Drug Details

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What are the generic sources for prednisolone acetate and what is the scope of prednisolone acetate patent protection?

Prednisolone acetate is the generic ingredient in eighteen branded drugs marketed by Schering, Akorn, Bel Mar, Cent Pharms, Watson Labs, Pfizer, Alcon, Novartis Pharms Corp, Allergan, Taro, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-seven NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Prednisolone acetate has thirty-three patent family members in fourteen countries.

There are eighty-seven drug master file entries for prednisolone acetate. Eleven suppliers are listed for this compound.

Summary for prednisolone acetate

International Patents:	33
US Patents:	4
Tradenames:	18
Applicants:	13
NDAs:	27
Drug Master File Entries:	87
Suppliers / Packagers:	11
Bulk Api Vendors:	56
Clinical Trials:	50
Patent Applications:	3,574
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for prednisolone acetate
DailyMed Link:	prednisolone acetate at DailyMed

Pharmacology for prednisolone acetate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Synonyms for prednisolone acetate

(11beta)-11,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl acetate

[2-[(8S,9S,10R,11S,13S,14S,17R)-10,13-dimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] ethanoate

[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] acetate

[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate

037P710

11b,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate

11beta,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate

2-((1S,10S,11S,15S,17S,2R,14R)-14,17-dihydroxy-2,15-dimethyl-5-oxotetracyclo[8 .7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-oxoethyl acetate

2-((8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate

2-[(1S,2R,10S,11S,14R,15S,17S)-14,17-DIHYDROXY-2,15-DIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-3,6-DIEN-14-YL]-2-OXOETHYL ACETATE

21-Acetoxy-1,4-pregnadiene-11beta,17alpha-diol-3,20-dione

4-08-00-03468 (Beilstein Handbook Reference)

52-21-1

8B2807733D

A828982

AB00443788_13

AB00443788-11

AB2000666

AC-2176

AC1L1L8T

acetic acid [2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] ester

AKOS007930677

AKOS015960469

AN-14231

AS-11673

BC201735

Bio-0646

Blephamide Liquifilm

Blephamide S.O.P.

BRN 3111798

C08180

CAS-52-21-1

Cetapred Ointment

CHEBI:8380

CHEMBL1152

component of Composone

component of Isopto Cetapred

component of Metimyd

component of Neo-Delta-Cortef

Cormalone

Cortipred

CS-4642

D00980

Delcort-E

Deltilen

DSSTox_CID_3502

DSSTox_GSID_23502

DSSTox_RID_77056

DTXSID3023502

Durapred

Econopred

Econopred (TN)

EINECS 200-134-1

HMS2234F18

HMS3259O07

HY-B1214

hydroprednisone acetate

LRJOMUJRLNCICJ-JZYPGELDSA-N

LS-118501

Meticortelone acetate

Meticotelone acetate

MFCD00037710

MLS000028512

MLS001148097

MLS002207146

MLS002548870

MolPort-002-507-143

NC00470

NCGC00021925-03

NCGC00094765-01

Nisolone

NSC 10966

NSC-10966

NSC10966

Omnipred

Opera_ID_332

P1283

PL008096

Pred Forte

Pred forte (TN)

Pred Forte TM 1%

Pred Mild

Pred-G Liquifilm

Pred-G S.O.P

Pred-G S.O.P.

Predalone 50

Prediacortine

Predicort

Prednelan-N

Prednidoren

Prednisolone (21-acetate)

Prednisolone 21-acetate

Prednisolone 21-acetate, >=97%

Prednisolone 21-acetate, VETRANAL(TM), analytical standard

Prednisolone acetate (JP17/USP/INN)

Prednisolone acetate (Omnipred)

Prednisolone acetate [BAN:JAN]

Prednisolone acetate [USP:JAN]

Prednisolone acetate for peak identification, European Pharmacopoeia (EP) Reference Standard

Prednisolone acetate, European Pharmacopoeia (EP) Reference Standard

Prednisolone Acetate, pharmaceutical secondary standard, traceable to USP, PhEur, BP

Prednisolone acetate, United States Pharmacopeia (USP) Reference Standard

PREDNISOLONE-21-ACETATE

Predonine injection

Pregna-1,20-dione, 11.beta.,17,21-trihydroxy-, 21-acetate

Pregna-1,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11.beta.)-

Pregna-1,4-diene-3,20-dione, 11-beta,17,21-trihydroxy-, 21-acetate

Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-, 21-acetate

Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-, 21-acetate (8CI)

Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11b)-

Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11beta)-

Prenema

Pricortin

Q-201614

s2570

SCHEMBL7999

SMR000058326

ST075202

Sterane IM and IA

Supercortyl

Tox21_111328

Tox21_111328_1

UNII-8B2807733D

Vasocidin Ointment

ZINC3875348

US Patents and Regulatory Information for prednisolone acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akorn	PREDAMIDE	prednisolone acetate; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	088059-001	Jul 29, 1983		DISCN	No	No
Pfizer	STERANE	prednisolone acetate	INJECTABLE;INJECTION	011446-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alcon	CETAPRED	prednisolone acetate; sulfacetamide sodium	OINTMENT;OPHTHALMIC	087771-001	Aug 6, 1993		DISCN	No	No
Pharmafair	PREDSULFAIR II	prednisolone acetate; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	088837-001	Dec 24, 1985		DISCN	No	No

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Expired US Patents for prednisolone acetate

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

Non-Orange Book US Patents for prednisolone acetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,206,727	Oral suspension of prednisolone acetate
8,461,139	Oral suspension of prednisolone acetate
6,355,258	Method for formulating spill resistant pharmaceutical compositions in semi-solid form

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International Patents for prednisolone acetate

Country	Document Number	Estimated Expiration
South Korea	20080044245
Canada	2616112
Japan	2009503097
Israel	140000