Assyro AI

Orange Book product · Brand (NDA)

CALQUENCE

ACALABRUTINIB MALEATE

Brand (NDA)NDA 216387RX ASTRAZENECA

At a glance

Aug 03, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

29

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 03, 2022

    3 yr 11 mo ago

  2. Today

  3. Patent 7459554 expires

    Listed drug substance patent expiration.

    Nov 24, 2026

    in 5 mo

  4. Exclusivity ends · I-960

    New indication exclusivity (3 years)

    Jan 16, 2028

    in 1 yr 7 mo

  5. Exclusivity ends · D-200

    New indication / change exclusivity (3 years)

    Feb 19, 2029

    in 2 yr 9 mo

  6. Patent 10239883 expires

    Listed method-of-use patent (U-2666) expiration.

    Jul 11, 2032

    in 6 yr 2 mo

  7. Patent 10239883 expires

    Listed method-of-use patent (U-2668) expiration.

    Jul 11, 2032

    in 6 yr 2 mo

  8. Patent 9290504 expires

    Listed drug substance patent expiration.

    Jul 11, 2032

    in 6 yr 2 mo

  9. Patent 9758524 expires

    Listed method-of-use patent (U-4108) expiration.

    Jul 11, 2032

    in 6 yr 2 mo

  10. Patent 9758524 expires

    Listed method-of-use patent (U-2145) expiration.

    Jul 11, 2032

    in 6 yr 2 mo

  11. Patent 10272083 expires

    Listed method-of-use patent (U-4109) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  12. Patent 10272083 expires

    Listed method-of-use patent (U-2519) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  13. Patent 10272083 expires

    Listed method-of-use patent (U-2682) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  14. Patent 10272083 expires

    Listed method-of-use patent (U-2683) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  15. Patent 10272083 expires

    Listed method-of-use patent (U-2684) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  16. Patent 10272083 expires

    Listed method-of-use patent (U-2685) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  17. Patent 10272083 expires

    Listed method-of-use patent (U-2686) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  18. Patent 10272083 expires

    Listed method-of-use patent (U-2687) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  19. Patent 11771696 expires

    Listed method-of-use patent (U-3710) expiration.

    Jan 21, 2035

    in 8 yr 9 mo

  20. Patent 11166951 expires

    Listed method-of-use patent (U-4426) expiration.

    Aug 11, 2035

    in 9 yr 3 mo

  21. Patent 11166951 expires

    Listed method-of-use patent (U-4427) expiration.

    Aug 11, 2035

    in 9 yr 3 mo

  22. Patent 11166951 expires

    Listed method-of-use patent (U-4428) expiration.

    Aug 11, 2035

    in 9 yr 3 mo

  23. Patent 11166951 expires

    Listed method-of-use patent (U-4429) expiration.

    Aug 11, 2035

    in 9 yr 3 mo

  24. Patent 11166951 expires

    Listed method-of-use patent (U-4430) expiration.

    Aug 11, 2035

    in 9 yr 3 mo

  25. Patent 11166951 expires

    Listed method-of-use patent (U-4431) expiration.

    Aug 11, 2035

    in 9 yr 3 mo

  26. Patent 11059829 expires

    Listed drug substance patent expiration.

    Jul 01, 2036

    in 10 yr 2 mo

  27. Patent 11059829 expires

    Listed drug substance patent expiration.

    Jul 01, 2036

    in 10 yr 2 mo

  28. Patent 11059829 expires

    Listed drug substance patent expiration.

    Jul 01, 2036

    in 10 yr 2 mo

  29. Patent 11059829 expires

    Listed drug substance patent expiration.

    Jul 01, 2036

    in 10 yr 2 mo

  30. Patent 11059829 expires

    Listed drug substance patent expiration.

    Jul 01, 2036

    in 10 yr 2 mo

  31. Patent 11059829 expires

    Listed drug substance patent expiration.

    Jul 01, 2036

    in 10 yr 2 mo

  32. Patent 11059829 expires

    Listed drug substance patent expiration.

    Jul 01, 2036

    in 10 yr 2 mo

  33. Patent 11059829 expires

    Listed drug substance patent expiration.

    Jul 01, 2036

    in 10 yr 2 mo

Pharmaceutical detail

Active ingredient

ACALABRUTINIB MALEATE

Strength

EQ 100MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 216387

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 (2)

  • I-960New indication exclusivity (3 years)

    Jan 16, 2028

    in 1 yr 7 mo

  • D-200New indication / change exclusivity (3 years)

    Feb 19, 2029

    in 2 yr 9 mo

Listed patents (29)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7459554Nov 24, 2026in 5 mo
Substance
10239883Jul 11, 2032in 6 yr 2 mo
U-2666
10239883Jul 11, 2032in 6 yr 2 mo
U-2668
9290504Jul 11, 2032in 6 yr 2 mo
SubstanceProduct
9758524Jul 11, 2032in 6 yr 2 mo
U-4108
9758524Jul 11, 2032in 6 yr 2 mo
U-2145
10272083Jan 21, 2035in 8 yr 9 mo
U-4109
10272083Jan 21, 2035in 8 yr 9 mo
U-2519
10272083Jan 21, 2035in 8 yr 9 mo
U-2682
10272083Jan 21, 2035in 8 yr 9 mo
U-2683
10272083Jan 21, 2035in 8 yr 9 mo
U-2684
10272083Jan 21, 2035in 8 yr 9 mo
U-2685
10272083Jan 21, 2035in 8 yr 9 mo
U-2686
10272083Jan 21, 2035in 8 yr 9 mo
U-2687
11771696Jan 21, 2035in 8 yr 9 mo
U-3710
11166951Aug 11, 2035in 9 yr 3 mo
U-4426
11166951Aug 11, 2035in 9 yr 3 mo
U-4427
11166951Aug 11, 2035in 9 yr 3 mo
U-4428
11166951Aug 11, 2035in 9 yr 3 mo
U-4429
11166951Aug 11, 2035in 9 yr 3 mo
U-4430
11166951Aug 11, 2035in 9 yr 3 mo
U-4431
11059829Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-4108
11059829Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-2145
11059829Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-2671
11059829Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-2670
11059829Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-2669
11059829Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-2668
11059829Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-2667
11059829Jul 01, 2036in 10 yr 2 mo
SubstanceProductU-2666
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