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ZETONNA Drug Profile

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Which patents cover Zetonna, and what generic alternatives are available?

Zetonna is a drug marketed by Covis Pharma Bv and is included in one NDA. There is one patent protecting this drug.

This drug has fourteen patent family members in twelve countries.

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

US ANDA Litigation and Generic Entry Outlook for Zetonna

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for ZETONNA

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	45
Clinical Trials:	1
Patent Applications:	3,901
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZETONNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZETONNA
DailyMed Link:	ZETONNA at DailyMed

Drug patent expirations by year for ZETONNA

Recent Clinical Trials for ZETONNA

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

Sponsor	Phase
Sunovion	Phase 4

See all ZETONNA clinical trials

Recent Litigation for ZETONNA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ORTHO-MCNEIL PHARMACEUTICAL, INC. v. LUPIN PHARMACEUTICALS, INC.	2006-10-17

See all ZETONNA litigation

Synonyms for ZETONNA

(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
(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 160
Alvesco 80
Alvesco HFA
Alvesco, Ciclesonide
B-9207-015
BDBM50247997
BI54903
BTR-15
BTR-15K
BY-9010
BYK-20426
C-23151
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
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))-
Q5119448
RPR 251526
RPR-251526
RPR251526
s4646
S59502J185
SCHEMBL3688
SR-01000942227
SR-01000942227-1
TBN-15
Tox21_112486
UNII-S59502J185
ZINC3915154

US Patents and Regulatory Information for ZETONNA

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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
Covis Pharma Bv	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012		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 ZETONNA

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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	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	Start Trial	Start Trial
Covis Pharma Bv	ZETONNA	ciclesonide	AEROSOL, METERED;NASAL	202129-001	Jan 20, 2012	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ZETONNA

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Country	Patent Number	Estimated Expiration
Portugal	983058	Start Trial
Slovakia	283930	Start Trial
Mexico	9203480	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ZETONNA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0983058	PA2005006,C0983058	Lithuania	Start Trial	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
0983058	CA 2005 00036	Denmark	Start Trial
0983058	SPC022/2005	Ireland	Start Trial	SPC022/2005, 20060612, EXPIRES: 20190415
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description