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Orange Book product · Brand (NDA)

COSELA

TRILACICLIB DIHYDROCHLORIDE

Brand (NDA)NDA 214200RX PHARMACOSMOS
View TRILACICLIB DIHYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Feb 12, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

17

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 12, 2021

    5 yr 5 mo ago

  2. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Feb 12, 2026

    4 mo ago

  3. Today

  4. Patent 10189849 expires

    Listed drug substance patent expiration.

    Oct 25, 2031

    in 5 yr 5 mo

  5. Patent 10189850 expires

    Listed drug product patent expiration.

    Oct 25, 2031

    in 5 yr 5 mo

  6. Patent 10927120 expires

    Listed drug product patent expiration.

    Oct 25, 2031

    in 5 yr 5 mo

  7. Patent 11040042 expires

    Listed drug product patent expiration.

    Oct 25, 2031

    in 5 yr 5 mo

  8. Patent 8598197 expires

    Listed drug substance patent expiration.

    Oct 25, 2031

    in 5 yr 5 mo

  9. Patent 9957276 expires

    Listed drug substance patent expiration.

    Oct 25, 2031

    in 5 yr 5 mo

  10. Patent 10085992 expires

    Listed method-of-use patent (U-3081) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  11. Patent 10966984 expires

    Listed method-of-use patent (U-3079) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  12. Patent 10966984 expires

    Listed method-of-use patent (U-3080) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  13. Patent 11717523 expires

    Listed method-of-use patent (U-3678) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  14. Patent 11717523 expires

    Listed method-of-use patent (U-3679) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  15. Patent 9487530 expires

    Listed method-of-use patent (U-3079) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  16. Patent 9487530 expires

    Listed method-of-use patent (U-3080) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  17. Patent 8598186 expires

    Listed drug substance patent expiration.

    Dec 30, 2034

    in 8 yr 8 mo

  18. Patent 12527798 expires

    Listed method-of-use patent (U-3504) expiration.

    Dec 05, 2037

    in 11 yr 8 mo

  19. Patent 11529352 expires

    Listed method-of-use patent (U-3504) expiration.

    Jul 23, 2039

    in 13 yr 3 mo

  20. Patent 12168666 expires

    Listed drug substance patent expiration.

    Nov 13, 2040

    in 14 yr 7 mo

Pharmaceutical detail

Active ingredient

TRILACICLIB DIHYDROCHLORIDE

Strength

EQ 300MG BASE/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 214200

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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 12, 2026

    4 mo ago

Listed patents (17)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10189849Oct 25, 2031in 5 yr 5 mo
Substance
10189850Oct 25, 2031in 5 yr 5 mo
Product
10927120Oct 25, 2031in 5 yr 5 mo
Product
11040042Oct 25, 2031in 5 yr 5 mo
Product
8598197Oct 25, 2031in 5 yr 5 mo
SubstanceProduct
9957276Oct 25, 2031in 5 yr 5 mo
Substance
10085992Mar 14, 2034in 7 yr 10 mo
U-3081
10966984Mar 14, 2034in 7 yr 10 mo
U-3079
10966984Mar 14, 2034in 7 yr 10 mo
U-3080
11717523Mar 14, 2034in 7 yr 10 mo
U-3678
11717523Mar 14, 2034in 7 yr 10 mo
U-3679
9487530Mar 14, 2034in 7 yr 10 mo
U-3079
9487530Mar 14, 2034in 7 yr 10 mo
U-3080
8598186Dec 30, 2034in 8 yr 8 mo
SubstanceProduct
12527798Dec 05, 2037in 11 yr 8 mo
U-3504
11529352Jul 23, 2039in 13 yr 3 mo
U-3504
12168666Nov 13, 2040in 14 yr 7 mo
SubstanceProduct
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