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FDA Orange Book · active-ingredient family

Trospium chloride; xanomeline tartrate

Trospium chloride; xanomeline tartrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:COBENFY · NDA 216158

1

Brand (NDA)

0

Generics (ANDA)

11

Listed patents

3

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
COBENFYRLD×3BRISTOL-MYERSNDA 216158—Sep 26, 2024

Marketing exclusivity (3)

  • NCENew chemical entity exclusivity (5 years)

    Sep 26, 2029

    in 3 yr 4 mo

  • NCENew chemical entity exclusivity (5 years)

    Sep 26, 2029

    in 3 yr 4 mo

  • NCENew chemical entity exclusivity (5 years)

    Sep 26, 2029

    in 3 yr 4 mo

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10695339Jul 21, 2030in 4 yr 2 mo
U-3513
10369144Jul 21, 2030in 4 yr 2 mo
ProductU-3513
10369143Jul 21, 2030in 4 yr 2 mo
U-3513
10265311Jul 21, 2030in 4 yr 2 mo
U-3513
10238643Jul 21, 2030in 4 yr 2 mo
Product
11890378Sep 27, 2039in 13 yr 6 mo
ProductU-3513
11471413Sep 27, 2039in 13 yr 6 mo
U-3513
11452692Sep 27, 2039in 13 yr 6 mo
U-3513
10933020Sep 27, 2039in 13 yr 6 mo
ProductU-3513
10925832Sep 27, 2039in 13 yr 6 mo
Product
12558317Oct 29, 2039in 13 yr 7 mo
Product

Trospium chloride; xanomeline tartrate — 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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