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Ciclesonide - Generic Drug Details

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What are the generic drug sources for ciclesonide and what is the scope of ciclesonide patent protection?

Ciclesonide is the generic ingredient in three branded drugs marketed by Astrazeneca Pharms and is included in three NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for ciclesonide. Two suppliers are listed for this compound.

Summary for ciclesonide

US Patents:	7
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	7
Suppliers / Packagers:	2
Bulk Api Vendors:	41
Clinical Trials:	67
Patent Applications:	5,600
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ciclesonide
DailyMed Link:	ciclesonide at DailyMed

Synonyms for ciclesonide

(11?,16?)-16,17-[[(R)-Cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-pregna-1,4-diene-3,20-dione

(11?,16?)-16,17-[[(R)-Cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)pregna-1,4-diene-3,20-dione

(11|A,16|A)-16,17-[[(R)-Cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-pregna-1,4-diene-3,20-dione

(R)-11beta,16alpha,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with cyclohexanecarboxaldehyde, 21-isobutyrate

126544-47-6

141845-82-1

2-((6aR,6bS,7S,8aS,8bS,10R,11aR,12aS,12bS)-10-cyclohexyl-7-hydroxy-6a,8a-dimethyl-4-oxo-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bH-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8b-yl)-

2-[(1S,2S,4R,6R,8S,9S,11S,12S,13R)-6-CYCLOHEXYL-11-HYDROXY-9,13-DIMETHYL-16-OXO-5,7-DIOXAPENTACYCLO[10.8.0.0(2),?.0?,?.0(1)(3),(1)?]ICOSA-14,17-DIEN-8-YL]-2-OXOETHYL 2-METHYLPROPANOATE

2-oxoethyl isobutyrate

2H-Naphth (2',1':4,5) indeno (1,2-d) (1,3) dioxole, pregna-1,4-diene-3,20-dione deriv.

544C476

AC-1330

AKOS015994702

Alvesco

Alvesco (TN)

Alvesco HFA

Alvesco, Ciclesonide

AN-15021

B-9207-015

BC220461

BTR-15

BTR-15K

BY-9010

BYK-20426

C-23151

C32H44O7

CAS-141845-82-1

CC-25775

CHEBI:31397

CHEMBL2040682

Ciclesonide (JAN/USAN/INN)

Ciclesonide [INN]

Ciclesonide [USAN:INN]

Ciclesonide, >=98% (HPLC)

Ciclesonide, European Pharmacopoeia (EP) Reference Standard

CS-2867

D01703

D0K7HU

DB01410

DR003211

DSSTox_CID_26659

DSSTox_GSID_46659

DSSTox_RID_81802

DTXSID9046659

el-87-6

GTPL7469

HY-B0625

KS-1165

LS-186047

LUKZNWIVRBCLON-GXOBDPJESA-N

MolPort-005-940-705

NCGC00167484-01

NCGC00167972-01

O945

Omnair

Omnaris

Omnaris (TN)

Omnaris HFA

Omniair (TN)

Osonase

Osonide

PL018866

Pregna-1,4-diene-3,20-dione, 16,17-(((R)-cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11beta,16alpha)-

Pregna-1,4-diene-3,20-dione, 16,17-((cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11beta,16alpha(R))-

RPR 251526

RPR-251526

RPR251526

s4646

S59502J185

SCHEMBL3688

SR-01000942227

SR-01000942227-1

TBN-15

Tox21_112486

UNII-S59502J185

Zetonna

ZINC3915154

US Patents and Regulatory Information for ciclesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Pharms	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		RX	Yes	Yes			Y
Astrazeneca Pharms	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008		RX	Yes	Yes
Astrazeneca Pharms	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes			Y
Astrazeneca Pharms	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		RX	Yes	Yes
Astrazeneca Pharms	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes			Y
Astrazeneca Pharms	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006		RX	Yes	Yes			Y
Astrazeneca Pharms	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008		RX	Yes	Yes			Y

Expired US Patents for ciclesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Pharms	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012
Astrazeneca Pharms	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012
Astrazeneca Pharms	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008
Astrazeneca Pharms	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008
Astrazeneca Pharms	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006
Astrazeneca Pharms	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008
Astrazeneca Pharms	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008

International Patents for ciclesonide

Country	Document Number	Estimated Expiration
Germany	69932905
China	101869570
Hong Kong	1149719
Taiwan	I225788
Eurasian Patent Organization	006015
Poland	197875
World Intellectual Property Organization (WIPO)	0128563

Supplementary Protection Certificates for ciclesonide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C022/2005	Ireland		SPC022/2005, 20060612, EXPIRES: 20190415
2005006	Lithuania		PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321
2005 00036	Denmark
2005006,C0983058	Lithuania		PRODUCT NAME: CICLESONIDUM (11BETA,16ALFA)-16,17-(((R)-CIKLOHEKSILMETILEN)BIS(OKSI))-11-HIDROKSI-21-(2-METIL-1OKSOPROPOKSI)PREGNA-1,4-DIEN-3,20-DIONAS; REGISTRATION NO/DATE: LT/1/05/0181/001, LT/1/05/0181/002, LT/1/05/0181/003 20050321