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Prednisolone acetate - Generic Drug Details
What are the generic sources for prednisolone acetate and what is the scope of prednisolone acetate patent protection?
Prednisolone acetate has thirty-three patent family members in fourteen countries.
There are eighty-six 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: | 86 |
Suppliers / Packagers: | 11 |
Bulk Api Vendors: | 54 |
Clinical Trials: | 1,329 |
Patent Applications: | 3,506 |
Formulation / Manufacturing: | see details |
Drug Prices: | see low prices |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 083398-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
Alcon | ISOPTO CETAPRED | prednisolone acetate; sulfacetamide sodium | SUSPENSION;OPHTHALMIC | 087547-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
Akorn | PREDAMIDE | prednisolone acetate; sulfacetamide sodium | SUSPENSION/DROPS;OPHTHALMIC | 088059-001 | Jul 29, 1983 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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 |
---|---|---|
6,355,258 | Method for formulating spill resistant pharmaceutical compositions in semi-solid form | ➤ Try a Free Trial |
8,206,727 | Oral suspension of prednisolone acetate | ➤ Try a Free Trial |
8,461,139 | Oral suspension of prednisolone acetate | ➤ Try a Free Trial |
Patent No. | Title | Estimated Patent Expiration |
International Patents for prednisolone acetate
Country | Document Number | Estimated Expiration |
---|---|---|
Japan | 4240814 | ➤ Try a Free Trial |
Austria | 312598 | ➤ Try a Free Trial |
South Africa | 200800926 | ➤ Try a Free Trial |
Israel | 170790 | ➤ Try a Free Trial |
Country | Document Number | Estimated Expiration |
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