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Prednisolone acetate - Generic Drug Details
What are the generic drug 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.There are eighty-eight drug master file entries for prednisolone acetate. Ten suppliers are listed for this compound.
Summary for prednisolone acetate
| US Patents: | 4 |
| Tradenames: | 18 |
| Applicants: | 13 |
| NDAs: | 27 |
| Drug Master File Entries: | 88 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 56 |
| Clinical Trials: | 50 |
| Patent Applications: | 3,574 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for prednisolone acetate |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | STERANE | prednisolone acetate | INJECTABLE;INJECTION | 011446-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Akorn | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 084492-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Akorn | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 083032-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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
| 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 | 022067-001 | 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 | 022067-002 | 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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ISSN: 2162-2639
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Major Patent Expirations 2018 - 2019
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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