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McKinsey
Boehringer Ingelheim
Express Scripts
Harvard Business School
Moodys
AstraZeneca

Last Updated: December 9, 2021

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UCERIS Drug Patent Profile


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

Uceris is a drug marketed by Salix and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in seventeen countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Uceris

A generic version of UCERIS was approved as budesonide by TEVA PHARMS on November 18th, 2008.

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Drug patent expirations by year for UCERIS
Drug Prices for UCERIS

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Drug Sales Revenue Trends for UCERIS

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Paragraph IV (Patent) Challenges for UCERIS
Tradename Dosage Ingredient NDA Submissiondate
UCERIS TABLET, EXTENDED RELEASE;ORAL budesonide 203634 2013-03-11

US Patents and Regulatory Information for UCERIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix UCERIS budesonide AEROSOL, FOAM;RECTAL 205613-001 Oct 7, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 UCERIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try it Free ⤷  Try it Free
Salix UCERIS budesonide AEROSOL, FOAM;RECTAL 205613-001 Oct 7, 2014 ⤷  Try it Free ⤷  Try it Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try it Free ⤷  Try it Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try it Free ⤷  Try it Free
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for UCERIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 LUC00208 Luxembourg ⤷  Try it Free PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024 2021C/518 Belgium ⤷  Try it Free PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024 301102 Netherlands ⤷  Try it Free PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
0613371 SPC/GB02/033 United Kingdom ⤷  Try it Free PRODUCT 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
2435024 132021000000095 Italy ⤷  Try it Free PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
McKinsey
Johnson and Johnson
Colorcon
Express Scripts

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 verification 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.