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FDA Orange Book · active-ingredient family

Iptacopan hydrochloride

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

Reference-listed drug:FABHALTA · NDA 218276

1

Brand (NDA)

0

Generics (ANDA)

8

Listed patents

5

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
FABHALTARLDNOVARTISNDA 218276—Dec 05, 2023

Marketing exclusivity (5)

  • I-949New indication exclusivity (3 years)

    Aug 07, 2027

    in 1 yr 2 mo

  • I-963New indication exclusivity (3 years)

    Mar 20, 2028

    in 1 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Dec 05, 2028

    in 2 yr 6 mo

  • ODE-456Orphan-drug exclusivity (7 years)

    Dec 05, 2030

    in 4 yr 6 mo

  • ODE-524Orphan-drug exclusivity (7 years)

    Mar 20, 2032

    in 5 yr 10 mo

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10093663Jul 14, 2034in 8 yr 2 mo
U-4161
9682968Jul 14, 2034in 8 yr 2 mo
SubstanceProduct
12285422Aug 30, 2038in 12 yr 5 mo
U-4181
11723901Aug 30, 2038in 12 yr 5 mo
U-3980
12384758May 17, 2041in 15 yr 2 mo
U-3980
11603363May 25, 2041in 15 yr 2 mo
SubstanceProduct
12453726Jul 15, 2041in 15 yr 4 mo
U-4300
11951101Jul 15, 2041in 15 yr 4 mo
U-3895

Iptacopan hydrochloride — 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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