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FDA Orange Book · active-ingredient family

Olanzapine; samidorphan l-malate

Olanzapine; samidorphan l-malate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:LYBALVI · NDA 213378

1

Brand (NDA)

0

Generics (ANDA)

14

Listed patents

4

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
LYBALVIRLD×4ALKERMES INCNDA 213378—May 28, 2021

Marketing exclusivity (4)

  • NCENew chemical entity exclusivity (5 years)

    May 28, 2026

    22 d ago

  • NCENew chemical entity exclusivity (5 years)

    May 28, 2026

    22 d ago

  • NCENew chemical entity exclusivity (5 years)

    May 28, 2026

    22 d ago

  • NCENew chemical entity exclusivity (5 years)

    May 28, 2026

    22 d ago

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11241425Aug 23, 2031in 5 yr 3 mo
U-3137
12194035Aug 23, 2031in 5 yr 3 mo
U-3141
11185541Aug 23, 2031in 5 yr 3 mo
U-3140
11793805Aug 23, 2031in 5 yr 3 mo
U-3734
11351166Aug 23, 2031in 5 yr 3 mo
U-3140
9126977Aug 23, 2031in 5 yr 3 mo
ProductU-3136
9517235Aug 23, 2031in 5 yr 3 mo
U-3139
10716785Aug 23, 2031in 5 yr 3 mo
U-3136
9119848Aug 30, 2031in 5 yr 3 mo
Substance
8778960Feb 13, 2032in 5 yr 9 mo
U-3136
10300054May 31, 2033in 7 yr 1 mo
ProductU-3140
11951111Nov 12, 2041in 15 yr 8 mo
U-3886
11707466Nov 12, 2041in 15 yr 8 mo
Product
12390474Nov 12, 2041in 15 yr 8 mo
Product

Olanzapine; samidorphan l-malate — 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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