Assyro AI

Orange Book product · Brand (NDA)

INJECTAFER

FERRIC CARBOXYMALTOSE

Brand (NDA)NDA 203565RX AM REGENT
View FERRIC CARBOXYMALTOSE familyOpen on FDA Orange Book

At a glance

Apr 28, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

25

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 28, 2021

    5 yr 3 mo ago

  2. Exclusivity ends · I-915

    New indication exclusivity (3 years)

    May 31, 2026

    19 d ago

  3. Today

  4. Patent 11364260 expires

    Listed method-of-use patent (U-3637) expiration.

    Jan 08, 2027

    in 7 mo

  5. Patent 11433091 expires

    Listed method-of-use patent (U-3435) expiration.

    Jan 08, 2027

    in 7 mo

  6. Patent 11433091 expires

    Listed method-of-use patent (U-3436) expiration.

    Jan 08, 2027

    in 7 mo

  7. Patent 11433091 expires

    Listed method-of-use patent (U-3437) expiration.

    Jan 08, 2027

    in 7 mo

  8. Patent 11433091 expires

    Listed method-of-use patent (U-3438) expiration.

    Jan 08, 2027

    in 7 mo

  9. Patent 11433091 expires

    Listed method-of-use patent (U-3634) expiration.

    Jan 08, 2027

    in 7 mo

  10. Patent 11478502 expires

    Listed method-of-use patent (U-3472) expiration.

    Jan 08, 2027

    in 7 mo

  11. Patent 11478502 expires

    Listed method-of-use patent (U-3473) expiration.

    Jan 08, 2027

    in 7 mo

  12. Patent 11478502 expires

    Listed method-of-use patent (U-3474) expiration.

    Jan 08, 2027

    in 7 mo

  13. Patent 8895612 expires

    Listed method-of-use patent (U-3115) expiration.

    Jan 08, 2027

    in 7 mo

  14. Patent 8895612 expires

    Listed method-of-use patent (U-3050) expiration.

    Jan 08, 2027

    in 7 mo

  15. Patent 8895612 expires

    Listed method-of-use patent (U-3116) expiration.

    Jan 08, 2027

    in 7 mo

  16. Patent 8895612 expires

    Listed method-of-use patent (U-1620) expiration.

    Jan 08, 2027

    in 7 mo

  17. Patent 8895612 expires

    Listed method-of-use patent (U-3051) expiration.

    Jan 08, 2027

    in 7 mo

  18. Patent 8895612 expires

    Listed method-of-use patent (U-3635) expiration.

    Jan 08, 2027

    in 7 mo

  19. Patent 8895612 expires

    Listed method-of-use patent (U-3316) expiration.

    Jan 08, 2027

    in 7 mo

  20. Patent 8895612 expires

    Listed method-of-use patent (U-3315) expiration.

    Jan 08, 2027

    in 7 mo

  21. Patent 7612109 expires

    Listed drug substance patent expiration.

    Feb 05, 2027

    in 8 mo

  22. Patent 7754702 expires

    Listed method-of-use patent (U-2555) expiration.

    Feb 15, 2028

    in 1 yr 8 mo

  23. Patent 7754702 expires

    Listed method-of-use patent (U-2557) expiration.

    Feb 15, 2028

    in 1 yr 8 mo

  24. Patent 7754702 expires

    Listed method-of-use patent (U-2556) expiration.

    Feb 15, 2028

    in 1 yr 8 mo

  25. Patent 7754702 expires

    Listed method-of-use patent (U-3636) expiration.

    Feb 15, 2028

    in 1 yr 8 mo

  26. Patent 7754702 expires

    Listed method-of-use patent (U-3313) expiration.

    Feb 15, 2028

    in 1 yr 8 mo

  27. Patent 7754702 expires

    Listed method-of-use patent (U-3314) expiration.

    Feb 15, 2028

    in 1 yr 8 mo

  28. Patent 7754702 expires

    Listed method-of-use patent (U-3312) expiration.

    Feb 15, 2028

    in 1 yr 8 mo

Pharmaceutical detail

Active ingredient

FERRIC CARBOXYMALTOSE

Strength

1GM IRON/20ML (50MG IRON/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 203565

Product number

003

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)

  • I-915New indication exclusivity (3 years)

    May 31, 2026

    19 d ago

Listed patents (25)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11364260Jan 08, 2027in 7 mo
U-3637
11433091Jan 08, 2027in 7 mo
U-3435
11433091Jan 08, 2027in 7 mo
U-3436
11433091Jan 08, 2027in 7 mo
U-3437
11433091Jan 08, 2027in 7 mo
U-3438
11433091Jan 08, 2027in 7 mo
U-3634
11478502Jan 08, 2027in 7 mo
U-3472
11478502Jan 08, 2027in 7 mo
U-3473
11478502Jan 08, 2027in 7 mo
U-3474
8895612Jan 08, 2027in 7 mo
U-3115
8895612Jan 08, 2027in 7 mo
U-3050
8895612Jan 08, 2027in 7 mo
U-3116
8895612Jan 08, 2027in 7 mo
U-1620
8895612Jan 08, 2027in 7 mo
U-3051
8895612Jan 08, 2027in 7 mo
U-3635
8895612Jan 08, 2027in 7 mo
U-3316
8895612Jan 08, 2027in 7 mo
U-3315
7612109Feb 05, 2027in 8 mo
SubstanceProduct
7754702Feb 15, 2028in 1 yr 8 mo
U-2555
7754702Feb 15, 2028in 1 yr 8 mo
U-2557
7754702Feb 15, 2028in 1 yr 8 mo
U-2556
7754702Feb 15, 2028in 1 yr 8 mo
U-3636
7754702Feb 15, 2028in 1 yr 8 mo
U-3313
7754702Feb 15, 2028in 1 yr 8 mo
U-3314
7754702Feb 15, 2028in 1 yr 8 mo
U-3312
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