Assyro AI

Orange Book product · Brand (NDA)

ROMVIMZA

VIMSELTINIB

Brand (NDA)NDA 219304RX DECIPHERA PHARMS

At a glance

Feb 14, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

12

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 14, 2025

    1 yr 4 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Feb 14, 2030

    in 3 yr 9 mo

  4. Patent 9181223 expires

    Listed drug substance patent expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  5. Patent 12285430 expires

    Listed method-of-use patent (U-4145) expiration.

    Dec 23, 2039

    in 13 yr 9 mo

  6. Patent 12485120 expires

    Listed method-of-use patent (U-4145) expiration.

    Dec 23, 2039

    in 13 yr 9 mo

  7. Patent 12582655 expires

    Listed method-of-use patent (U-4145) expiration.

    Dec 23, 2039

    in 13 yr 9 mo

  8. Patent 11103507 expires

    Listed method-of-use patent (U-4145) expiration.

    Feb 03, 2040

    in 13 yr 10 mo

  9. Patent 11679110 expires

    Listed method-of-use patent (U-4145) expiration.

    Feb 03, 2040

    in 13 yr 10 mo

  10. Patent 12447149 expires

    Listed drug product patent expiration.

    Dec 06, 2044

    in 18 yr 9 mo

  11. Patent 12528787 expires

    Listed drug substance patent expiration.

    Dec 06, 2044

    in 18 yr 9 mo

  12. Patent 12551483 expires

    Listed drug product patent expiration.

    Dec 06, 2044

    in 18 yr 9 mo

  13. Patent 12617775 expires

    Listed drug substance patent expiration.

    Dec 06, 2044

    in 18 yr 9 mo

  14. Patent 12643883 expires

    Listed drug substance patent expiration.

    Dec 06, 2044

    in 18 yr 9 mo

  15. Patent 12509443 expires

    Listed drug product patent expiration.

    Apr 30, 2045

    in 19 yr 2 mo

Pharmaceutical detail

Active ingredient

VIMSELTINIB

Strength

20MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 219304

Product number

002

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)

    Feb 14, 2030

    in 3 yr 9 mo

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9181223Mar 14, 2034in 7 yr 10 mo
SubstanceProduct
12285430Dec 23, 2039in 13 yr 9 mo
U-4145
12485120Dec 23, 2039in 13 yr 9 mo
U-4145
12582655Dec 23, 2039in 13 yr 9 mo
U-4145
11103507Feb 03, 2040in 13 yr 10 mo
U-4145
11679110Feb 03, 2040in 13 yr 10 mo
U-4145
12447149Dec 06, 2044in 18 yr 9 mo
Product
12528787Dec 06, 2044in 18 yr 9 mo
SubstanceProduct
12551483Dec 06, 2044in 18 yr 9 mo
Product
12617775Dec 06, 2044in 18 yr 9 mo
SubstanceProduct
12643883Dec 06, 2044in 18 yr 9 mo
SubstanceProduct
12509443Apr 30, 2045in 19 yr 2 mo
Product
Agent CTA Background

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