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ALVESCO Drug Profile

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Alvesco is a drug marketed by Takeda Gmbh and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug.

This drug has one hundred and three patent family members in thirty-eight countries.

The generic ingredient in ALVESCO 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: ALVESCO

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Clinical Trials for: ALVESCO

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYes5,482,934<disabled>YY <disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYes<disabled><disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 2008RXYes6,006,745<disabled>Y <disabled>
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Expired Patents for Tradename: ALVESCO

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-003Jan 10, 20086,036,942<disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-003Jan 10, 20085,775,321<disabled>
Takeda Gmbh
ALVESCO
ciclesonide
AEROSOL, METERED;INHALATION021658-002Jan 10, 20085,605,674<disabled>
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Non-Orange Book Patents for Tradename: ALVESCO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,036,942 Seal configuration for aerosol canister<disabled in preview>
6,030,682 Container for aerosol formulation<disabled in preview>
5,290,539 Device for delivering an aerosol<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ALVESCO

Country Document Number Estimated Expiration
Czech Republic298253<disabled in preview>
Canada2050812<disabled in preview>
Germany4129535<disabled in preview>
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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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Supplementary Protection Certificates for Tradename: ALVESCO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2005 00036Denmark<disabled>
2005006,C0983058Lithuania<disabled>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
C022/2005Ireland<disabled>SPC022/2005, 20060612, EXPIRES: 20190415
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