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FDA Orange Book · active-ingredient family

Lomitapide mesylate

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

Reference-listed drug:JUXTAPID · NDA 203858

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

6

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
JUXTAPIDRLD×7CHIESINDA 203858—Feb 25, 2026

Marketing exclusivity (6)

  • NSNew strength exclusivity (3 years)

    Feb 25, 2029

    in 2 yr 9 mo

  • NPPNew patient population exclusivity (3 years)

    Feb 25, 2029

    in 2 yr 9 mo

  • NPPNew patient population exclusivity (3 years)

    Feb 25, 2029

    in 2 yr 9 mo

  • NPPNew patient population exclusivity (3 years)

    Feb 25, 2029

    in 2 yr 9 mo

  • NPPNew patient population exclusivity (3 years)

    Feb 25, 2029

    in 2 yr 9 mo

  • NPPNew patient population exclusivity (3 years)

    Feb 25, 2029

    in 2 yr 9 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7932268Aug 19, 2027in 1 yr 2 mo
U-1316
12472172Jul 29, 2041in 15 yr 4 mo
U-4438

Lomitapide mesylate — 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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