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UCERIS Drug Profile

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Uceris is a drug marketed by Valeant Pharms Intl and is included in two NDAs. It is available from two suppliers. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-four patent family members in eighteen countries.

The generic ingredient in UCERIS is budesonide. There are nineteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for Tradename: UCERIS

Patents:10
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: UCERIS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Intl
UCERIS
budesonide
AEROSOL, FOAM;RECTAL205613-001Oct 7, 2014RXYes5,914,122► subscribeY ► subscribe
Valeant Pharms Intl
UCERIS
budesonide
TABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYes8,895,064► subscribeY ► subscribe
Valeant Pharms Intl
UCERIS
budesonide
TABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYes9,192,581► subscribeY ► subscribe
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Expired Patents for Tradename: UCERIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl
UCERIS
budesonide
AEROSOL, FOAM;RECTAL205613-001Oct 7, 20145,914,122► subscribe
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Paragraph IV activity for: UCERIS

Drugname Dosage Strength RLD Submissiondate
budesonideExtended-release Tablets9 mgUceris3/11/2013

Non-Orange Book Patents for Tradename: UCERIS

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
7,410,652Controlled release and taste masking oral pharmaceutical composition► subscribe
8,029,823Controlled release and taste masking oral pharmaceutical composition► subscribe
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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: UCERIS

Country Document Number Estimated Expiration
China1355693► subscribe
Japan2011102311► subscribe
MexicoPA01012889► 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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Supplementary Protection Certificates for Tradename: UCERIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/033United Kingdom► subscribePRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
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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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