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BETAMETHASONE DIPROPIONATE - Generic Drug Details
What are the generic sources for betamethasone dipropionate and what is the scope of freedom to operate?
Betamethasone dipropionate
is the generic ingredient in eleven branded drugs marketed by Anda Repository, Fougera Pharms, Glenmark Generics, Perrigo Israel, Taro, Schering, Merck Sharp Dohme, Savage Labs, Acp Nimble, Actavis Mid Atlantic, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Hi Tech, Teligent Pharma Inc, Alpharma Us Pharms, Fougera Pharms Inc, Lupin Ltd, Encore Dermat, Leo Pharma As, Perrigo Uk Finco, Tolmar, and Glenmark Pharms, and is included in sixty-seven NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Betamethasone dipropionate has seven patent family members in five countries.
There are sixty-six drug master file entries for betamethasone dipropionate. Twenty-three suppliers are listed for this compound.
Summary for BETAMETHASONE DIPROPIONATE
| International Patents: | 7 |
| US Patents: | 13 |
| Tradenames: | 11 |
| Applicants: | 24 |
| NDAs: | 67 |
| Drug Master File Entries: | 66 |
| Suppliers / Packagers: | 23 |
| Bulk Api Vendors: | 75 |
| Clinical Trials: | 56 |
| Patent Applications: | 7,118 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for BETAMETHASONE DIPROPIONATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BETAMETHASONE DIPROPIONATE |
| DailyMed Link: | BETAMETHASONE DIPROPIONATE at DailyMed |
Recent Clinical Trials for BETAMETHASONE DIPROPIONATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Phase 4 |
| Eli Lilly and Company | Phase 4 |
| Drug Delivery Solutions Ltd. (part of MC2 Therapeutics) | Phase 1 |
Recent Litigation for BETAMETHASONE DIPROPIONATE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Promius Pharma LLC v. Perrigo UK FINCO Limited Partnership | 2018-05-22 |
Pharmacology for BETAMETHASONE DIPROPIONATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Synonyms for BETAMETHASONE DIPROPIONATE
| .beta.-Methasone 17,21-dipropionate |
| (11-beta,16-beta)-9-Chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione |
| (11.beta.,16.beta.)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate |
| (11beta,16beta)-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate |
| (8S,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-(2-(propionyloxy)acetyl)-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl propionate |
| (8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-(2-(propionyloxy)acetyl)-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthr |
| [2-(9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl)-2-oxoethyl] propanoate |
| [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate |
| 2-((2S,10S,11S,13S,15S,17S,1R,14R)-1-fluoro-17-hydroxy-2,13,15-trimethyl-5-oxo -14-propanoyloxytetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-o xoethyl propanoate |
| 5593-20-4 |
| 593B204 |
| 826Y60901U |
| 9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate |
| 9-Fluoro-11.beta.-hydroxy-16.beta.-methyl-3,20-dioxo-17-(propionyloxy)pregna-1,4-dien-21-yl propionate # |
| 9-Fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate |
| 9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate |
| 9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-di(propionate) |
| 9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate |
| 9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate |
| 9alpha-Fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17,21-Dipropionate |
| 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene- 17,21-diyl dipropionate |
| 9alpha-Fluoro-16beta-methyl-11beta,17alpha,21-trihydroxy-1,4-pregnadiene-3,20-dione 17,21-dipropionate |
| AB01274713_02 |
| AB01274713-01 |
| AB01275498-01 |
| AB2000220 |
| AC-2161 |
| AKOS015960446 |
| AKOS015969733 |
| AKOS025312304 |
| AKOS037482518 |
| Alphatrex |
| API0001696 |
| AS-13826 |
| B3166 |
| BDBM50421892 |
| Beloderm |
| beta-Methasone 17,21-dipropionate |
| Betamethasone 17,21-dipropionate |
| BETAMETHASONE DIPROP |
| betamethasone dipropionat |
| Betamethasone Dipropionate (Diprolene) |
| Betamethasone dipropionate (JP17/USP) |
| Betamethasone dipropionate [USAN:BAN:JAN] |
| Betamethasone dipropionate [USAN:USP:JAN] |
| betamethasone propionate |
| Betamethasone-17,21-dipropionate |
| Betamethasone-Dipropionate(Diprolene) |
| BRD-K58148589-001-03-6 |
| BRN 3638108 |
| C-22966 |
| C28H37FO7 |
| CAS-5593-20-4 |
| CC-24614 |
| CHEBI:31276 |
| CHEMBL1200384 |
| CHEMBL1449610 |
| CIWBQSYVNNPZIQ-GXPAWERTSA-N |
| CIWBQSYVNNPZIQ-UHFFFAOYSA-N |
| CIWBQSYVNNPZIQ-XYWKZLDCSA-N |
| component of Alphatrex (Salt/Mix) |
| component of Betasone (Salt/Mix) |
| CS-7549 |
| D01637 |
| Diproderm |
| Diprolene |
| Diprolene (TN) |
| Diprolene AF |
| Diprosis |
| Diprosone |
| Diprospan;Diprolene;Diprosone;Diprolene AF;Diprolene |
| DSSTox_CID_2672 |
| DSSTox_GSID_22672 |
| DSSTox_RID_76683 |
| DTXSID2022672 |
| EBD2157850 |
| EINECS 227-005-2 |
| en-17-yl propionate |
| FT-0082786 |
| HMS2090K11 |
| HY-13571 |
| J10388 |
| KS-5303 |
| LS-118474 |
| Maxivate |
| MCULE-9093329990 |
| MFCD00133140 |
| NCGC00159360-02 |
| NCGC00159443-01 |
| NCGC00159443-02 |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methyl-,17,21-dipropionate |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-, 17,21-dipropionate |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-,17,21-dipropionate |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)- |
| Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta) |
| Pregna-1,4-diene-3,20-dione,9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11b,16b)- |
| Psorion |
| Q4897349 |
| Rinderon DP |
| Rinderon-DP (TN) |
| S 3440 |
| S-3440 |
| s1688 |
| SC-15701 |
| Sch 11460 |
| Sch-11460 |
| SCHEMBL4566 |
| SCHEMBL7519 |
| Sernivo |
| Sernivo (TN) |
| ST024761 |
| STL451053 |
| Tox21_113343 |
| UNII-826Y60901U |
| ZINC4212137 |
Paragraph IV (Patent) Challenges for BETAMETHASONE DIPROPIONATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SERNIVO | SPRAY;TOPICAL | betamethasone dipropionate | 208079 | 2018-02-15 |
US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Perrigo New York | BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | CREAM;TOPICAL | 074579-001 | Nov 26, 1997 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Taro | BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 076543-001 | Dec 9, 2003 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Leo Pharma As | TACLONEX | betamethasone dipropionate; calcipotriene | SUSPENSION;TOPICAL | 022185-001 | May 9, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Savage Labs | ALPHATREX | betamethasone dipropionate | LOTION;TOPICAL | 070273-001 | Aug 12, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Taro | BETAMETHASONE DIPROPIONATE | betamethasone dipropionate | LOTION;TOPICAL | 072276-001 | Aug 24, 1988 | DISCN | No | No | Start Trial | Start Trial | Start 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 BETAMETHASONE DIPROPIONATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | DIPROLENE AF | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 019555-001 | Apr 27, 1987 | Start Trial | Start Trial |
| Schering | DIPROLENE | betamethasone dipropionate | CREAM, AUGMENTED;TOPICAL | 019408-001 | Jan 31, 1986 | Start Trial | Start Trial |
| Merck Sharp Dohme | DIPROLENE | betamethasone dipropionate | OINTMENT, AUGMENTED;TOPICAL | 018741-001 | Jul 27, 1983 | Start Trial | Start Trial |
| Merck Sharp Dohme | DIPROLENE | betamethasone dipropionate | LOTION, AUGMENTED;TOPICAL | 019716-001 | Aug 1, 1988 | Start Trial | Start Trial |
| Schering | DIPROLENE | betamethasone dipropionate | GEL, AUGMENTED;TOPICAL | 019408-002 | Nov 22, 1991 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BETAMETHASONE DIPROPIONATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3141246 | Start Trial |
| Denmark | 2473161 | Start Trial |
| Spain | 2637447 | Start Trial |
| Japan | 2013503203 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011026076 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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