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Last Updated: August 11, 2020

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UCERIS Drug Profile

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When do Uceris patents expire, and when can generic versions of Uceris launch?

Uceris is a drug marketed by Salix and is included in two NDAs. There are fourteen 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-five suppliers are listed for this compound. Additional details are available on the budesonide profile page.

US ANDA Litigation and Generic Entry Outlook for Uceris

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

  Start Trial

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   Start Trial   Start Trial   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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   Start Trial   Start Trial
Salix UCERIS budesonide AEROSOL, FOAM;RECTAL 205613-001 Oct 7, 2014   Start Trial   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013   Start Trial   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013   Start Trial   Start Trial
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013   Start Trial   Start Trial
>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
0613371 SPC/GB02/033 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Dow
Mallinckrodt
Express Scripts
Johnson and Johnson

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