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FDA Orange Book · active-ingredient family

Levoketoconazole

Levoketoconazole is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:RECORLEV · NDA 214133

1

Brand (NDA)

0

Generics (ANDA)

9

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
RECORLEVRLDSTRONGBRIDGENDA 214133—Dec 30, 2021

Marketing exclusivity (2)

  • NCE*FDA marketing exclusivity

    Dec 30, 2026

    in 6 mo

  • ODE-385Orphan-drug exclusivity (7 years)

    Dec 30, 2028

    in 2 yr 7 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11478471Jan 10, 20265 mo ago
U-3283
10835530Jan 10, 20265 mo ago
U-3283
10517868Jan 10, 20265 mo ago
U-3283
10098877Jan 10, 20265 mo ago
U-3283
9918984May 03, 2028in 1 yr 11 mo
U-3283
12377096Mar 02, 2040in 13 yr 11 mo
U-4236
11278547Mar 02, 2040in 13 yr 11 mo
U-3282
11903940Mar 02, 2040in 13 yr 11 mo
U-3821
11020393Mar 02, 2040in 13 yr 11 mo
U-3282

Levoketoconazole — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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