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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 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Beclomethasone dipropionate has two hundred and forty-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:	248
US Patents:	8
Tradenames:	11
Applicants:	4
NDAs:	11
Drug Master File Entries:	20
Suppliers / Packagers:	5
Bulk Api Vendors:	45
Clinical Trials:	78
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No			Y
Schering	VANCERIL	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	017573-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014		RX	Yes	No			Y

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Expired US Patents for beclomethasone dipropionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000

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.

Patent No.	Title	Estimated Patent Expiration
8,978,966	Dose counters for inhalers, inhalers and methods of assembly thereof
9,108,010	Dose counters for inhalers, inhalers and methods of assembly thereof
9,174,013	Dose counters for inhalers, inhalers and methods of assembly thereof
9,216,260	Dose counters for inhalers, inhalers and methods of assembly thereof

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International Patents for beclomethasone dipropionate

Country	Document Number	Estimated Expiration
Eurasian Patent Organization	201300237
South Korea	20130103824
China	105597206
Japan	5785160