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FDA Orange Book · active-ingredient family

Setmelanotide acetate

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

Reference-listed drug:IMCIVREE · NDA 213793

1

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

6

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
IMCIVREERLDRHYTHMNDA 213793—Nov 25, 2020

Marketing exclusivity (6)

  • I-987New indication exclusivity (3 years)

    Mar 19, 2029

    in 2 yr 9 mo

  • NPPNew patient population exclusivity (3 years)

    Dec 20, 2027

    in 1 yr 6 mo

  • ODE-336Orphan-drug exclusivity (7 years)

    Nov 25, 2027

    in 1 yr 5 mo

  • ODE-402Orphan-drug exclusivity (7 years)

    Jun 16, 2029

    in 3 yr

  • ODE-508Orphan-drug exclusivity (7 years)

    Dec 20, 2031

    in 5 yr 7 mo

  • ODE-509Orphan-drug exclusivity (7 years)

    Dec 20, 2031

    in 5 yr 7 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9458195Oct 13, 2027in 1 yr 4 mo
SubstanceProduct
8039435Aug 21, 2032in 6 yr 3 mo
SubstanceProduct
11129869Jul 04, 2034in 8 yr 2 mo
Product

Setmelanotide acetate — 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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