FDA Orange Book

Is there a generic for Rinvoq?

Rinvoq contains upadacitinib. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Rinvoq (upadacitinib). The Orange Book shows its last listed patent expires March 9, 2038 and its last listed exclusivity ends April 28, 2032.

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Rinvoq products in the Orange Book

Rinvoq products and approved generics
Form and route	Strength	Brand status	Brand TE	Generic TE codes
tablet, extended release, oral	15MG	Marketed (Rx)	None	None
tablet, extended release, oral	30MG	Marketed (Rx)	None	None
tablet, extended release, oral	45MG	Marketed (Rx)	None	None

NDA 211675, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Rinvoq patents

Patents listed for Rinvoq
Patent	Expires	Covers	Use code	NDA
8962629	January 15, 2031	Drug substance	U-3371	211675
8962629	January 15, 2031	Drug substance	U-3624	211675
8962629	January 15, 2031	Drug substance	U-3946	211675
8962629	January 15, 2031	Drug substance	U-3945	211675
8962629	January 15, 2031	Drug substance	U-3275	211675
8962629	January 15, 2031	Drug substance	U-3255	211675
8962629	January 15, 2031	Drug substance	U-3341	211675
RE47221	August 16, 2033	Drug substance	None	211675
11512092	October 17, 2036	Method of use	U-3946	211675
11365198	October 17, 2036	Method of use	U-3946	211675
11773106	October 17, 2036	Method of use	U-3946	211675
11976077	October 17, 2036	Method of use	U-3298	211675
11524964	October 17, 2036	Method of use	U-3371	211675
11365198	October 17, 2036	Method of use	U-3275	211675
11512092	October 17, 2036	Method of use	U-3275	211675
11512092	October 17, 2036	Method of use	U-3487	211675
11512092	October 17, 2036	Method of use	U-3371	211675
11795175	October 17, 2036	Method of use	U-3255	211675
11535624	October 17, 2036	Method of use	U-3255	211675
11535625	October 17, 2036	Method of use	U-3298	211675
11773106	October 17, 2036	Method of use	U-3275	211675
11773106	October 17, 2036	Method of use	U-3487	211675
11773106	October 17, 2036	Method of use	U-3371	211675
12365689	October 17, 2036	Method of use	U-3945	211675
11993605	October 17, 2036	Method of use	U-3275	211675
11993605	October 17, 2036	Method of use	U-3946	211675
11993606	October 17, 2036	Method of use	U-3487	211675
11767326	October 17, 2036	Method of use	U-3298	211675
10995095	October 17, 2036	Method of use	U-3298	211675
10597400	October 17, 2036	Method of use	U-3255	211675
11780848	October 17, 2036	Method of use	U-3371	211675
12570664	October 17, 2036	Method of use	U-4454	211675
11198697	October 17, 2036	Drug product	None	211675
11661425	October 17, 2036	Drug substance, Drug product	None	211675
12103933	October 17, 2036	Drug product	None	211675
11773105	October 17, 2036	Drug substance, Drug product	None	211675
12110298	October 17, 2036	Drug substance, Drug product	None	211675
10981924	October 17, 2036	Drug product	None	211675
11787815	October 17, 2036	Drug product	None	211675
12077545	October 17, 2036	Drug product	None	211675
11780847	October 17, 2036	Drug product	None	211675
9963459	October 17, 2036	Drug product	None	211675
11718627	October 17, 2036	Drug substance, Drug product	None	211675
12110297	October 17, 2036	Drug product	None	211675
9951080	October 17, 2036	Drug substance, Drug product	None	211675
10981923	October 17, 2036	Drug substance	None	211675
11680069	October 17, 2036	Drug substance, Drug product	None	211675
11186584	October 17, 2036	Drug substance	None	211675
10519164	October 17, 2036	Drug product	None	211675
10550126	October 17, 2036	Method of use	U-3298	211675
11535626	October 17, 2036	Method of use	U-3298	211675
12091415	October 17, 2036	Drug product	None	211675
10344036	October 17, 2036	Drug product	None	211675
12116373	October 17, 2036	Drug product	None	211675
10730883	October 17, 2036	Drug product	None	211675
10202393	October 17, 2036	Drug product	None	211675
12134621	October 17, 2036	Drug product	None	211675
11607411	March 9, 2038	Method of use	U-4302	211675
11564922	March 9, 2038	Method of use	U-4303	211675
11607411	March 9, 2038	Method of use	U-3341	211675

Showing 60 of 61 listed patents.

Rinvoq exclusivity

Exclusivity listed for Rinvoq
Code	Meaning	Expires	NDA
I-919	New indication	May 18, 2026	211675
I-946	New indication	April 26, 2027	211675
NPP	New patient population	April 26, 2027	211675
I-966	New indication	April 28, 2028	211675
ODE-481	Orphan drug exclusivity	April 26, 2031	211675
ODE-538	Orphan drug exclusivity	April 28, 2032	211675

Rinvoq NDC codes

Questions

Is there a generic for Rinvoq?

What is the generic name for Rinvoq?

The active ingredient in Rinvoq is upadacitinib, per the FDA Orange Book.

When does the Rinvoq patent expire?

The last patent listed for Rinvoq in the Orange Book expires March 9, 2038. 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.

Is there a generic for Rinvoq?

Map Rinvoq and your other top fills to their generics

Rinvoq products in the Orange Book

Rinvoq patents

Rinvoq exclusivity

Rinvoq NDC codes

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