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FDA Orange Book · active-ingredient family

Lumateperone tosylate

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

Reference-listed drug:CAPLYTA · NDA 209500

1

Brand (NDA)

0

Generics (ANDA)

25

Listed patents

6

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
CAPLYTARLD×3INTRA-CELLULARNDA 209500—Apr 22, 2022

Marketing exclusivity (6)

  • I-904New indication exclusivity (3 years)

    Nov 05, 2028

    in 2 yr 5 mo

  • M-319New use / labeling-change exclusivity (3 years)

    Apr 24, 2029

    in 2 yr 11 mo

  • I-904New indication exclusivity (3 years)

    Nov 05, 2028

    in 2 yr 5 mo

  • M-319New use / labeling-change exclusivity (3 years)

    Apr 24, 2029

    in 2 yr 11 mo

  • I-904New indication exclusivity (3 years)

    Nov 05, 2028

    in 2 yr 5 mo

  • M-319New use / labeling-change exclusivity (3 years)

    Apr 24, 2029

    in 2 yr 11 mo

Listed patents (25)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10464938Mar 12, 2028in 1 yr 9 mo
Product
9199995Mar 12, 2029in 2 yr 9 mo
U-4343
RE48825Mar 12, 2029in 2 yr 9 mo
Substance
9586960Mar 12, 2029in 2 yr 9 mo
SubstanceProduct
10117867May 27, 2029in 3 yr
U-3271
9168258May 27, 2029in 3 yr
Product
9616061May 27, 2029in 3 yr
Product
8648077Dec 01, 2029in 3 yr 6 mo
SubstanceProduct
8598119Dec 28, 2029in 3 yr 7 mo
U-543Delisted
RE48839Aug 19, 2033in 7 yr 3 mo
U-4344
11026951Dec 03, 2034in 8 yr 7 mo
U-3364
9956227Dec 03, 2034in 8 yr 7 mo
U-2714
10960009Dec 03, 2034in 8 yr 7 mo
U-814
12409176Mar 15, 2039in 12 yr 11 mo
U-4261
11806348Aug 30, 2039in 13 yr 5 mo
ProductU-3363
11690842Aug 30, 2039in 13 yr 5 mo
ProductU-4341
11052084Aug 30, 2039in 13 yr 5 mo
ProductU-4341
10695345Aug 30, 2039in 13 yr 5 mo
ProductU-814
12128043Aug 30, 2039in 13 yr 5 mo
ProductU-3362
12070459Aug 30, 2039in 13 yr 5 mo
ProductU-3362
11980617Oct 27, 2039in 13 yr 7 mo
U-4342
12090155Jul 07, 2040in 14 yr 3 mo
ProductU-4000
12122792Dec 10, 2040in 14 yr 8 mo
ProductU-4019
11753419Dec 10, 2040in 14 yr 8 mo
ProductDelisted
12410195Dec 10, 2040in 14 yr 8 mo
Product

Lumateperone tosylate — 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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