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FDA Orange Book · active-ingredient family

Inavolisib

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

Reference-listed drug:ITOVEBI · NDA 219249

1

Brand (NDA)

0

Generics (ANDA)

7

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ITOVEBIRLD×2GENENTECH INCNDA 219249—Oct 10, 2024

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Oct 10, 2029

    in 3 yr 4 mo

  • NCENew chemical entity exclusivity (5 years)

    Oct 10, 2029

    in 3 yr 4 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8343955Sep 27, 2030in 4 yr 4 mo
U-4024
8242104Sep 27, 2030in 4 yr 4 mo
SubstanceProduct
11760753Jul 01, 2036in 10 yr 2 mo
U-4024
9650393Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-4024
10851091Jul 01, 2036in 10 yr 2 mo
SubstanceProduct
11028100Apr 26, 2038in 12 yr
SubstanceProduct
12410189Jun 14, 2038in 12 yr 2 mo
U-4024

Inavolisib — 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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