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Last Updated: October 22, 2019

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OMNARIS Drug Profile

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When do Omnaris patents expire, and when can generic versions of Omnaris launch?

Omnaris is a drug marketed by Covis Pharma Bv and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in OMNARIS is ciclesonide. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ciclesonide profile page.

Drug patent expirations by year for OMNARIS
Drug Prices for OMNARIS

See drug prices for OMNARIS

Recent Clinical Trials for OMNARIS

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

SponsorPhase
TakedaPhase 3
SunovionPhase 4
West Penn Allegheny Health SystemPhase 4

See all OMNARIS clinical trials

Synonyms for OMNARIS
(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
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 (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

US Patents and Regulatory Information for OMNARIS

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   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 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
>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 OMNARIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   Start Trial   Start Trial
Covis Pharma Bv OMNARIS ciclesonide SPRAY, METERED;NASAL 022004-001 Oct 20, 2006   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
Paragraph IV (Patent) Challenges for OMNARIS
Drugname Dosage Strength RLD Date
➤ Subscribe Nasal Spray 250 mcg ➤ Subscribe   Start Trial

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