Assyro AI

Orange Book product · Brand (NDA)

COBENFY

TROSPIUM CHLORIDE; XANOMELINE TARTRATE

Brand (NDA)NDA 216158RX BRISTOL-MYERS

At a glance

Sep 26, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

11

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 26, 2024

    1 yr 9 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Sep 26, 2029

    in 3 yr 4 mo

  4. Patent 10238643 expires

    Listed drug product patent expiration.

    Jul 21, 2030

    in 4 yr 2 mo

  5. Patent 10265311 expires

    Listed method-of-use patent (U-3513) expiration.

    Jul 21, 2030

    in 4 yr 2 mo

  6. Patent 10369143 expires

    Listed method-of-use patent (U-3513) expiration.

    Jul 21, 2030

    in 4 yr 2 mo

  7. Patent 10369144 expires

    Listed drug product patent expiration.

    Jul 21, 2030

    in 4 yr 2 mo

  8. Patent 10695339 expires

    Listed method-of-use patent (U-3513) expiration.

    Jul 21, 2030

    in 4 yr 2 mo

  9. Patent 10925832 expires

    Listed drug product patent expiration.

    Sep 27, 2039

    in 13 yr 6 mo

  10. Patent 10933020 expires

    Listed drug product patent expiration.

    Sep 27, 2039

    in 13 yr 6 mo

  11. Patent 11452692 expires

    Listed method-of-use patent (U-3513) expiration.

    Sep 27, 2039

    in 13 yr 6 mo

  12. Patent 11471413 expires

    Listed method-of-use patent (U-3513) expiration.

    Sep 27, 2039

    in 13 yr 6 mo

  13. Patent 11890378 expires

    Listed drug product patent expiration.

    Sep 27, 2039

    in 13 yr 6 mo

  14. Patent 12558317 expires

    Listed drug product patent expiration.

    Oct 29, 2039

    in 13 yr 7 mo

Pharmaceutical detail

Active ingredient

TROSPIUM CHLORIDE; XANOMELINE TARTRATE

Strength

30MG;EQ 125MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 216158

Product number

003

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • 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
10238643Jul 21, 2030in 4 yr 2 mo
Product
10265311Jul 21, 2030in 4 yr 2 mo
U-3513
10369143Jul 21, 2030in 4 yr 2 mo
U-3513
10369144Jul 21, 2030in 4 yr 2 mo
ProductU-3513
10695339Jul 21, 2030in 4 yr 2 mo
U-3513
10925832Sep 27, 2039in 13 yr 6 mo
Product
10933020Sep 27, 2039in 13 yr 6 mo
ProductU-3513
11452692Sep 27, 2039in 13 yr 6 mo
U-3513
11471413Sep 27, 2039in 13 yr 6 mo
U-3513
11890378Sep 27, 2039in 13 yr 6 mo
ProductU-3513
12558317Oct 29, 2039in 13 yr 7 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.