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Serving leading biopharmaceutical companies globally:

Citi
Chinese Patent Office
Deloitte
Fish and Richardson
Harvard Business School
Dow
Cerilliant
UBS
Argus Health
Julphar

Generated: December 17, 2017

DrugPatentWatch Database Preview

UCERIS Drug Profile

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Which patents cover Uceris, and when can generic versions of Uceris launch?

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

This drug has twenty-six patent family members in seventeen countries and one supplementary protection certificate in one country.

The generic ingredient in UCERIS is budesonide. There are twenty drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Drug patent expirations by year for UCERIS

Pharmacology for UCERIS

Medical Subject Heading (MeSH) Categories for UCERIS

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms IntlUCERISbudesonideAEROSOL, FOAM;RECTAL205613-001Oct 7, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlUCERISbudesonideTABLET, EXTENDED RELEASE;ORAL203634-001Jan 14, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges 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
9,737,489Controlled release and taste masking oral pharmaceutical composition► Subscribe
9,592,203Controlled 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
Turkey200200562► Subscribe
Japan2003501457► Subscribe
Japan5279851► Subscribe
Japan2011102311► Subscribe
Japan5279850► Subscribe
MexicoPA01012889► Subscribe
Denmark1183014► Subscribe
China1355693► Subscribe
Japan2011102310► Subscribe
Germany60005819► 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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Serving leading biopharmaceutical companies globally:

Colorcon
Accenture
Express Scripts
Teva
Cerilliant
Cipla
Moodys
Fish and Richardson
Johnson and Johnson
Dow

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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