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Last Updated: February 26, 2020

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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 freedom to operate?

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 eleven patent family members in thirty-five countries.

There are twenty drug master file entries for beclomethasone dipropionate. Three suppliers are listed for this compound.

Recent Clinical Trials for beclomethasone dipropionate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Aurobindo Pharma LtdPhase 3
Adamis Pharmaceuticals CorporationPhase 3
Amneal Ireland LimitedPhase 3

See all beclomethasone dipropionate clinical trials

Recent Litigation for beclomethasone dipropionate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Branded Pharmaceutical Products R&D, Inc. v. Lupin Alantis Holdings SA2017-03-21
Teva Branded Pharmaceutical Products R&D Inc. v. Perrigo Pharmaceuticals Co.2013-08-16
MERCK SHARP & DOHME CORP. v. APOTEX INC.2009-12-18

See all beclomethasone dipropionate litigation

Pharmacology for beclomethasone dipropionate
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
Teva Branded Pharm QVAR 40 beclomethasone dipropionate AEROSOL, METERED;INHALATION 020911-002 Sep 15, 2000 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline BECONASE beclomethasone dipropionate AEROSOL, METERED;NASAL 018584-001 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
Teva Branded Pharm QVAR 80 beclomethasone dipropionate AEROSOL, METERED;INHALATION 020911-001 Sep 15, 2000 DISCN 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
Schering VANCENASE beclomethasone dipropionate AEROSOL, METERED;NASAL 018521-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Schering VANCERIL beclomethasone dipropionate AEROSOL, METERED;INHALATION 017573-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Teva Branded Pharm QVAR 40 beclomethasone dipropionate AEROSOL, METERED;INHALATION 020911-002 Sep 15, 2000   Start Trial   Start Trial
Glaxosmithkline BECLOVENT beclomethasone dipropionate AEROSOL, METERED;INHALATION 018153-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Schering VANCERIL beclomethasone dipropionate AEROSOL, METERED;INHALATION 017573-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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