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FDA Orange Book · active-ingredient family

Omaveloxolone

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

Reference-listed drug:SKYCLARYS · NDA 216718

1

Brand (NDA)

0

Generics (ANDA)

7

Listed patents

3

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
SKYCLARYSRLDBIOGEN USNDA 216718—Feb 28, 2023

Marketing exclusivity (3)

  • M-270New use / labeling-change exclusivity (3 years)

    Dec 20, 2027

    in 1 yr 6 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 28, 2028

    in 1 yr 9 mo

  • ODE-427Orphan-drug exclusivity (7 years)

    Feb 28, 2030

    in 3 yr 9 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11091430Apr 20, 2029in 2 yr 11 mo
U-3552
11919838Apr 20, 2029in 2 yr 11 mo
U-3862
9670147Apr 20, 2029in 2 yr 11 mo
Substance
8440854Apr 20, 2029in 2 yr 11 mo
Product
8124799Dec 03, 2029in 3 yr 6 mo
Substance
9701709Apr 24, 2033in 6 yr 11 mo
SubstanceProduct
8993640Apr 24, 2033in 6 yr 11 mo
SubstanceProduct

Omaveloxolone — 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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