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Beclomethasone dipropionate - Generic Drug Details
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What are the generic sources for beclomethasone dipropionate and what is the scope of patent protection?
Beclomethasone dipropionate
is the generic ingredient in eleven branded drugs marketed by Glaxosmithkline, Teva Branded Pharm, Norton Waterford, and Schering, and is included in eleven NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Beclomethasone dipropionate has three hundred and nine patent family members in thirty-five countries.
There are twenty drug master file entries for beclomethasone dipropionate. Three suppliers are listed for this compound.
Summary for beclomethasone dipropionate
| International Patents: | 309 |
| US Patents: | 10 |
| Tradenames: | 11 |
| Applicants: | 4 |
| NDAs: | 11 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 51 |
| Clinical Trials: | 86 |
| Patent Applications: | 7,845 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for beclomethasone dipropionate |
| DailyMed Link: | beclomethasone dipropionate at DailyMed |
Recent Clinical Trials for beclomethasone dipropionate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aurobindo Pharma Ltd | Phase 3 |
| Adamis Pharmaceuticals Corporation | Phase 3 |
| Amneal Ireland Limited | Phase 3 |
Recent Litigation for beclomethasone dipropionate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. v. Lupin Alantis Holdings SA | 2017-03-21 |
| Teva Branded Pharmaceutical Products R&D Inc. v. Perrigo Pharmaceuticals Co. | 2013-08-16 |
| MERCK SHARP & DOHME CORP. v. APOTEX INC. | 2009-12-18 |
Pharmacology for beclomethasone dipropionate
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Synonyms for beclomethasone dipropionate
| (11beta,16beta)-9-chloro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)pregna-1,4-diene-3,20-dione |
| (11beta,16beta)-9-chloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate |
| [(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-(2-propanoyloxyacetyl)-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate |
| [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] propanoate |
| [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-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-[(1R,2S,10S,11S,13S,14R,15S,17S)-1-chloro-17-hydroxy-2,13,15-trimethyl-5-oxo-14-(propanoyloxy)tetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-3,6-dien-14-yl]-2-oxoethyl propanoate |
| 32278-EP2281815A1 |
| 32278-EP2295408A1 |
| 32278-EP2301933A1 |
| 32278-EP2305640A2 |
| 32278-EP2311827A1 |
| 34135-07-4 |
| 534B098 |
| 5534-09-8 |
| 5B307S63B2 |
| 9-AE-11|A,17,21-EyoC>>u-16|A-(1/4)x>>uOEthcThorn-1,4- paragraph signthornI(c)-3,20- paragraph signthornI feminine-17,21- paragraph signthorn+/-uEao yen |
| 9-Chloro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate |
| 9-Chloro-11|A,17,21-trihydroxy-16|A-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate |
| 9-Chloro-11beta-hydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate |
| 9-Chloro-11beta, 17,21-trihydroxy-16 beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate |
| 9-Chloro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate |
| 9-chloro-16beta-methyl-11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione 17,21-dipropionate |
| AB1009261 |
| AC-2159 |
| AC1L2IWA |
| AC1Q62MZ |
| Aerobec |
| AKOS015951275 |
| Alanase |
| Aldecin |
| Aldecina |
| Aldecine |
| AN-14214 |
| API0001601 |
| Atomase |
| B4464 |
| Beclacin |
| Beclate |
| Beclazone |
| Beclazone 250 |
| Beclocort Nasel |
| Becloforte |
| Beclomet |
| Beclomet Nasal |
| Beclometasone (beclomethasone) dipropionate, British Pharmacopoeia (BP) Assay Standard |
| Beclometasone 17,21-dipropionate |
| Beclometasone dipropionate |
| Beclometasone dipropionate (JP17) |
| Beclometasone dipropionate for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Beclometasone dipropionate for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Beclometasone dipropionato |
| Beclomethasone dipropionate (USP) |
| Beclomethasone dipropionate [USAN:USP] |
| Beclomethasone dipropionate [USAN] |
| Beclomethasone dipropionate, analytical standard, for drug analysis |
| Beclomethasone dipropionate, anhydrous, European Pharmacopoeia (EP) Reference Standard |
| Beclomethasone Dipropionate, Pharmaceutical Secondary Standard; Certified Reference Material |
| Beclomethasone dipropionate, United States Pharmacopeia (USP) Reference Standard |
| Beclorhinol |
| Becloturmant |
| Beclovent |
| Beclovent (TN) |
| Beconase |
| Beconase AQ |
| Benconase |
| BPBio1_000957 |
| BRD-K97810537-001-03-7 |
| BRD-K97810537-001-13-6 |
| BSPBio_000869 |
| C07813 |
| C28H37ClO7 |
| CAS-5534-09-8 |
| CCG-220855 |
| CHEBI:3002 |
| CHEMBL1200500 |
| Clenil |
| Clenil-A |
| CPD001233361 |
| CS-1503 |
| CTK8F7938 |
| D00689 |
| DB00394 |
| DSSTox_CID_28656 |
| DSSTox_GSID_48730 |
| DSSTox_RID_82926 |
| DTXSID3048730 |
| EINECS 226-886-0 |
| Entyderma |
| GTPL5894 |
| HMS1570L11 |
| HMS2097L11 |
| HMS2235O23 |
| HMS3259H03 |
| HMS3714L11 |
| HY-13571A |
| Inalone O |
| Inalone R |
| Korbutone |
| KUVIULQEHSCUHY-XYWKZLDCSA-N |
| KW-053 |
| LS-118439 |
| Menaderm |
| MFCD00135613 |
| MLS002154034 |
| MolPort-003-983-412 |
| NC00610 |
| NCGC00094596-03 |
| NCGC00179392-01 |
| Pregna-1-4-diene-3,20-dione, 9-chloro-16-beta-methyl-11-beta,17,21-trihydroxy-,17,21-dipropionate |
| Pregna-1,4-diene-3,20-dione, 9-chloro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)- |
| Pregna-1,4-diene-3,20-dione, 9-chloro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta)- |
| Pregna-1,4-diene-3,20-dione, 9-chloro-16-beta-methyl-11-beta,17,21-trihydroxy-, 17,21-dipropionate |
| Prestwick_990 |
| Prestwick0_000855 |
| Prestwick1_000855 |
| Prestwick2_000855 |
| Prestwick3_000855 |
| Propaderm |
| Propaderm Forte |
| Propionic acid beclomethasone |
| QNASL |
| Qnasl (TN) |
| Qvar |
| QVAR 40 |
| Qvar 80 |
| Respocort |
| Rhino Clenil |
| Rhinosol |
| Rino-clenil |
| s3078 |
| Sanasthmax |
| Sanasthmyl |
| SCH 18020W |
| SCHEMBL6890 |
| SMR001233361 |
| SPBio_002790 |
| Spir |
| ST24046007 |
| Tox21_113168 |
| Turbinal |
| UNII-5B307S63B2 |
| Vancenase |
| Vanceril |
| Vanceril (TN) |
| Vanceril Double Strength |
| Ventolair |
| Viarox |
| W-5080 |
| ZINC3938744 |
US Patents and Regulatory Information for beclomethasone dipropionate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Schering | VANCERIL DOUBLE STRENGTH | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 020486-001 | Dec 24, 1996 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Schering | VANCENASE AQ | beclomethasone dipropionate monohydrate | SPRAY, METERED;NASAL | 020469-001 | Jun 26, 1996 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Schering | VANCENASE | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 018521-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-002 | Aug 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-001 | Aug 3, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | 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 beclomethasone dipropionate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | QVAR 80 | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 020911-001 | Sep 15, 2000 | Start Trial | Start Trial |
| Schering | VANCERIL | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 017573-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Glaxosmithkline | BECLOVENT | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 018153-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Teva Branded Pharm | QVAR 80 | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 020911-001 | Sep 15, 2000 | Start Trial | Start Trial |
| Glaxosmithkline | BECONASE | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 018584-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for beclomethasone dipropionate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2496741 | Start Trial |
| South Korea | 101475968 | Start Trial |
| Israel | 223116 | Start Trial |
| Japan | 2014111199 | Start Trial |
| Peru | 14922013 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.