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Last Updated: October 23, 2019

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Ciclesonide - Generic Drug Details

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

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

Ciclesonide has one hundred and fifty-six patent family members in forty-three countries.

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

Drug Prices for ciclesonide

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Recent Clinical Trials for ciclesonide

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

SponsorPhase
Tehran University of Medical SciencesPhase 3
SunovionPhase 1
National Heart, Lung, and Blood Institute (NHLBI)Phase 3

See all ciclesonide clinical trials

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-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
AC1MIWNR
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
DB01410
DSSTox_CID_26659
DSSTox_GSID_46659
DSSTox_RID_81802
DTXSID9046659
el-87-6
GTPL7469
HMS3714N07
HY-B0625
KS-1165
LS-186047
LUKZNWIVRBCLON-GXOBDPJESA-N
MolPort-005-940-705
NCGC00167484-01
NCGC00167972-01
O945
Omnair
Omnaris
Omnaris (TN)
Omnaris HFA
Osonase
Osonide
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
Paragraph IV (Patent) Challenges for CICLESONIDE
Tradename Dosage Ingredient NDA Submissiondate
OMNARIS SPRAY, METERED;NASAL ciclesonide 022004 2012-02-13

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
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Covis Pharma Bv ZETONNA ciclesonide AEROSOL, METERED;NASAL 202129-001 Jan 20, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006 RX Yes Yes   Start Trial   Start Trial   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 ciclesonide

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

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