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FDA Orange Book · active-ingredient family

Cocaine hydrochloride

Cocaine hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:NUMBRINO · NDA 209575

2

Brand (NDA)

0

Generics (ANDA)

12

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
NUMBRINORLDOMNIVIUM PHARMSNDA 209575—Jan 10, 2020
GOPRELTORLDLXO IRELANDNDA 209963—Dec 14, 2017

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10016407Feb 07, 2037in 10 yr 10 mo
U-2329
9867815Feb 07, 2037in 10 yr 10 mo
U-2225
10413505Feb 07, 2037in 10 yr 10 mo
U-2479
10420760Feb 07, 2037in 10 yr 10 mo
U-2478
10149843Feb 07, 2037in 10 yr 10 mo
U-2479
10933060Feb 07, 2037in 10 yr 10 mo
U-3014
10973811Feb 07, 2037in 10 yr 10 mo
U-2226
10987347Feb 07, 2037in 10 yr 10 mo
U-2225
10894012Feb 07, 2037in 10 yr 10 mo
U-3014
10857095Feb 07, 2037in 10 yr 10 mo
U-3014
10231961Feb 07, 2037in 10 yr 10 mo
Product
11040032Feb 07, 2037in 10 yr 10 mo
Product

Cocaine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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