FDA Orange Book

Is there a generic for Nouress?

Nouress contains cysteine. 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 Nouress (cysteine). The Orange Book shows its last listed patent expires March 15, 2039.

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Nouress products in the Orange Book

Nouress products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, intravenous500MG/10ML (50MG/ML)Marketed (Rx)None0None

NDA 212535, held by BAXTER HEALTHCARE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Nouress patents

Patents listed for Nouress
PatentExpiresCoversUse codeNDA
10478453January 15, 2039Drug productU-2752212535
10583155January 15, 2039Drug productU-2752212535
11510942January 15, 2039Drug productU-2752212535
11826383January 15, 2039Drug productNone212535
10905714January 15, 2039Drug productNone212535
11642370January 15, 2039Drug productNone212535
10918662January 15, 2039Drug productNone212535
12569514January 15, 2039Drug productNone212535
11648262January 15, 2039Drug productNone212535
11679125January 15, 2039Drug productNone212535
10653719January 15, 2039Drug productNone212535
10912795January 15, 2039Drug productNone212535
10933089January 15, 2039Drug productNone212535
10905713January 15, 2039Drug productNone212535
11684636January 15, 2039Drug productNone212535
11510941March 2, 2039Drug productNone212535
10543186March 15, 2039Method of useU-2722212535
11045438March 15, 2039Drug productNone212535
10493051March 15, 2039Drug productNone212535
10702490March 15, 2039Drug productNone212535

Nouress NDC codes

Questions

Is there a generic for Nouress?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Nouress (cysteine). The Orange Book shows its last listed patent expires March 15, 2039.

What is the generic name for Nouress?

The active ingredient in Nouress is cysteine, per the FDA Orange Book.

When does the Nouress patent expire?

The last patent listed for Nouress in the Orange Book expires March 15, 2039. 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.

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