Last Updated: September 28, 2026

Details for New Drug Application (NDA): 203634

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NDA 203634 describes UCERIS, which is a drug marketed by Salix and is included in two NDAs. It is available from three suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the UCERIS profile page.

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

Summary for 203634

Tradename:	UCERIS
Applicant:	Salix
Ingredient:	budesonide
Patents:	5

Pharmacology for NDA: 203634

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 203634

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Suppliers and Packaging for NDA: 203634

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634	NDA	Santarus Inc.	68012-309	68012-309-01	2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01)
UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634	NDA	Santarus Inc.	68012-309	68012-309-02	2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	9MG
Approval Date:	Jan 14, 2013	TE:	AB	RLD:	Yes
Patent:	10,307,375	Patent Expiration:	Sep 7, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,660,858	Patent Expiration:	Sep 7, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,895,064	Patent Expiration:	Sep 7, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203634

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	9,532,954	⤷ Start Trial
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	7,431,943	⤷ Start Trial
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	10,064,878	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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