FDA Orange Book

Is there a generic for Numbrino?

Numbrino contains cocaine. 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 Numbrino (cocaine). The Orange Book shows its last listed patent expires February 7, 2037.

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Numbrino products in the Orange Book

Numbrino products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, nasal4%Marketed (Rx)None0None

NDA 209575, held by OMNIVIUM PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Numbrino patents

Patents listed for Numbrino
PatentExpiresCoversUse codeNDA
10973811February 7, 2037Method of useU-3680209575
10894012February 7, 2037Method of useU-3014209575
10857095February 7, 2037Method of useU-3014209575
10420760February 7, 2037Method of useU-2478209575
10413505February 7, 2037Method of useU-3014209575
10149843February 7, 2037Method of useU-2478209575
10149843February 7, 2037Method of useU-2479209575
10016407February 7, 2037Method of useU-2225209575
10016407February 7, 2037Method of useU-2226209575
10016407February 7, 2037Method of useU-2329209575
9867815February 7, 2037Method of useU-2225209575
9867815February 7, 2037Method of useU-2329209575
9867815February 7, 2037Method of useU-2227209575
9867815February 7, 2037Method of useU-2226209575
10933060February 7, 2037Method of useU-2478209575
10933060February 7, 2037Method of useU-3014209575
11040032February 7, 2037Drug productNone209575
10231961February 7, 2037Drug productNone209575

Numbrino NDC codes

Questions

Is there a generic for Numbrino?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Numbrino (cocaine). The Orange Book shows its last listed patent expires February 7, 2037.

What is the generic name for Numbrino?

The active ingredient in Numbrino is cocaine, per the FDA Orange Book.

When does the Numbrino patent expire?

The last patent listed for Numbrino in the Orange Book expires February 7, 2037. 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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