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OMNARIS Drug Profile

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Omnaris is a drug marketed by Takeda Gmbh and is included in one NDA. It is available from three suppliers. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-two patent family members in fifty countries.

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

Summary for Tradename: OMNARIS

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYes5,482,934► subscribeYY ► subscribe
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYes6,767,901► subscribeY ► subscribe
Takeda Gmbh
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYes8,371,292► subscribe ► subscribe
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Paragraph IV activity for: OMNARIS

Drugname Dosage Strength RLD Submissiondate
ciclesonideNasal Spray250 mcgOmnaris2/13/2012

International Patent Family for Tradename: OMNARIS

Country Document Number Estimated Expiration
Indonesia24818► subscribe
CroatiaP20140257► subscribe
Czech Republic297779► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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