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Beclomethasone dipropionate - Generic Drug Details

What are the generic sources for beclomethasone dipropionate and what is the scope of beclomethasone dipropionate 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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Beclomethasone dipropionate has two hundred and thirty-eight patent family members in thirty-one countries.

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

Summary for beclomethasone dipropionate

International Patents:	238
US Patents:	6
Tradenames:	11
Applicants:	4
NDAs:	11
Drug Master File Entries:	20
Suppliers / Packagers:	5
Bulk Api Vendors:	45
Clinical Trials:	176
Patent Applications:	7,451
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for beclomethasone dipropionate
DailyMed Link:	beclomethasone dipropionate at DailyMed

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
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),?.0(1)(1),(1)?]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
Ambap5534-09-8
AN-14214
API0001601
Atomase
B4464
Beclacin
Beclate
Beclazone
Beclazone 250
Beclocort Nasel
Becloforte
Beclomet
Beclomet Nasal
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 MONOHYDRATE
Beclomethasone dipropionate, analytical standard, for drug analysis
Beclomethasone dipropionate, anhydrous, European Pharmacopoeia (EP) Reference Standard
Beclomethasone Dipropionate, pharmaceutical secondary standard, traceable to USP, PhEur, BP
Beclomethasone dipropionate, United States Pharmacopeia (USP) Reference Standard
Beclorhinol
Becloturmant
Beclovent
Beclovent (TN)
Beconase
Beconase AQ
Benconase
BPBio1_000957
BRD-K97810537-001-03-7
BSPBio_000869
C07813
C28H37ClO7
CAS-5534-09-8
CCG-220855
CHEBI:3002
CHEMBL1200500
Clenil
Clenil-A
CPD001233361
CS-1503
CTK8F7938
D00689
DSSTox_CID_28656
DSSTox_GSID_48730
DSSTox_RID_82926
DTXSID3048730
EINECS 226-886-0
Entyderma
GTPL5894
HMS1570L11
HMS2097L11
HMS2235O23
HMS3259H03
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
PL000448
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	VANCERIL	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	017573-001	Approved Prior to Jan 1, 1982		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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Expired US Patents for beclomethasone dipropionate

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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	➤ Sign Up	➤ Sign Up
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012	➤ Sign Up	➤ Sign Up
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000	➤ Sign Up	➤ Sign Up
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Non-Orange Book US Patents for beclomethasone dipropionate

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.

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Patent No.	Title	Estimated Patent Expiration
9,533,111	Dose counters for inhalers, inhalers and methods of assembly thereof	➤ Sign Up
9,174,013	Dose counters for inhalers, inhalers and methods of assembly thereof	➤ Sign Up
8,978,966	Dose counters for inhalers, inhalers and methods of assembly thereof	➤ Sign Up
6,553,988	Medicament dispensing device with a multimaterial diaphragm bounding a pneumatic force chamber	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration