FDA Orange Book

Generic for Uceris

Uceris contains budesonide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Uceris is budesonide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Uceris products in the Orange Book

Uceris products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
aerosol, foam, rectal	2MG/ACTUATION	Marketed (Rx)	AB	1	AB
tablet, extended release, oral	9MG	Marketed (Rx)	AB	2	AB

NDA 205613, 203634, held by SALIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic budesonide

Approved generic versions of Uceris
Company	ANDA	TE code	Approved	Strengths
ACTAVIS LABORATORIES FL INC	205457	AB (A-rated, therapeutically equivalent)	July 3, 2018	9MG
MYLAN PHARMACEUTICALS INC	208851	AB (A-rated, therapeutically equivalent)	September 17, 2020	9MG
PADAGIS ISRAEL PHARMACEUTICALS LTD	215328	AB (A-rated, therapeutically equivalent)	April 12, 2023	2MG/ACTUATION

Uceris patents

Patents listed for Uceris
Patent	Expires	Covers	Use code	NDA
9192581	September 7, 2031	Drug product	U-1325	203634
8895064	September 7, 2031	Drug product	None	203634
10660858	September 7, 2031	Drug product	None	203634
10307375	September 7, 2031	Drug product	None	203634
9132093	September 7, 2031	Drug product	None	203634

Uceris NDC codes

Questions

Is there a generic for Uceris?

Yes. The generic name for Uceris is budesonide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Uceris?

The active ingredient in Uceris is budesonide, per the FDA Orange Book.

When does the Uceris patent expire?

The last patent listed for Uceris in the Orange Book expires September 7, 2031. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.