Assyro AI

Orange Book product · Brand (NDA)

LYNPARZA

OLAPARIB

Brand (NDA)NDA 208558RX ASTRAZENECA
View OLAPARIB familyOpen on FDA Orange Book

At a glance

Aug 17, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

57

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 17, 2017

    9 yr ago

  2. Exclusivity ends · I-914

    New indication exclusivity (3 years)

    May 31, 2026

    19 d ago

  3. Today

  4. Exclusivity ends · ODE-283

    Orphan-drug exclusivity (7 years)

    Dec 27, 2026

    in 6 mo

  5. Exclusivity ends · ODE-306

    Orphan-drug exclusivity (7 years)

    May 08, 2027

    in 11 mo

  6. Patent 8071579 expires

    Listed method-of-use patent (U-3631) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  7. Patent 8071579 expires

    Listed method-of-use patent (U-2716) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  8. Patent 8071579 expires

    Listed method-of-use patent (U-2483) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  9. Patent 8071579 expires

    Listed method-of-use patent (U-2482) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  10. Patent 8071579 expires

    Listed method-of-use patent (U-3695) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  11. Patent 8071579 expires

    Listed method-of-use patent (U-2820) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  12. Patent 8071579 expires

    Listed method-of-use patent (U-2824) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  13. Patent 8071579 expires

    Listed method-of-use patent (U-2833) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  14. Patent 8071579 expires

    Listed method-of-use patent (U-2823) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  15. Patent 8071579 expires

    Listed method-of-use patent (U-2832) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  16. Patent 8071579 expires

    Listed method-of-use patent (U-2480) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  17. Patent 8071579 expires

    Listed method-of-use patent (U-2821) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  18. Patent 8071579 expires

    Listed method-of-use patent (U-2819) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  19. Patent 8071579 expires

    Listed method-of-use patent (U-2822) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  20. Patent 8071579 expires

    Listed method-of-use patent (U-3333) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  21. Patent 8143241 expires

    Listed method-of-use patent (U-2482) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  22. Patent 8143241 expires

    Listed method-of-use patent (U-2480) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  23. Patent 8143241 expires

    Listed method-of-use patent (U-2716) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  24. Patent 8143241 expires

    Listed method-of-use patent (U-2483) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  25. Patent 8143241 expires

    Listed method-of-use patent (U-3631) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  26. Patent 8143241 expires

    Listed method-of-use patent (U-2824) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  27. Patent 8143241 expires

    Listed method-of-use patent (U-2823) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  28. Patent 8143241 expires

    Listed method-of-use patent (U-2821) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  29. Patent 8143241 expires

    Listed method-of-use patent (U-2819) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  30. Patent 8143241 expires

    Listed method-of-use patent (U-2820) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  31. Patent 8143241 expires

    Listed method-of-use patent (U-2822) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  32. Patent 8143241 expires

    Listed method-of-use patent (U-3695) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  33. Patent 8143241 expires

    Listed method-of-use patent (U-2832) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  34. Patent 8143241 expires

    Listed method-of-use patent (U-2833) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  35. Patent 8143241 expires

    Listed method-of-use patent (U-3333) expiration.

    Aug 12, 2027

    in 1 yr 2 mo

  36. Patent 7449464 expires

    Listed drug substance patent expiration.

    Sep 08, 2027

    in 1 yr 3 mo

  37. Patent 11633396 expires

    Listed drug product patent expiration.

    Oct 07, 2029

    in 3 yr 4 mo

  38. Patent 11975001 expires

    Listed drug product patent expiration.

    Oct 07, 2029

    in 3 yr 4 mo

  39. Patent 12048695 expires

    Listed drug product patent expiration.

    Oct 07, 2029

    in 3 yr 4 mo

  40. Patent 12144810 expires

    Listed drug product patent expiration.

    Oct 07, 2029

    in 3 yr 4 mo

  41. Patent 12178816 expires

    Listed drug product patent expiration.

    Oct 07, 2029

    in 3 yr 4 mo

  42. Patent 8475842 expires

    Listed drug product patent expiration.

    Dec 31, 2029

    in 3 yr 7 mo

  43. Patent 8859562 expires

    Listed method-of-use patent (U-2101) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  44. Patent 8859562 expires

    Listed method-of-use patent (U-2483) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  45. Patent 8859562 expires

    Listed method-of-use patent (U-2482) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  46. Patent 8859562 expires

    Listed method-of-use patent (U-2716) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  47. Patent 8859562 expires

    Listed method-of-use patent (U-2480) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  48. Patent 8859562 expires

    Listed method-of-use patent (U-3631) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  49. Patent 8859562 expires

    Listed method-of-use patent (U-2103) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  50. Patent 8859562 expires

    Listed method-of-use patent (U-2833) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  51. Patent 8859562 expires

    Listed method-of-use patent (U-2822) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  52. Patent 8859562 expires

    Listed method-of-use patent (U-2821) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  53. Patent 8859562 expires

    Listed method-of-use patent (U-2823) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  54. Patent 8859562 expires

    Listed method-of-use patent (U-2824) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  55. Patent 8859562 expires

    Listed method-of-use patent (U-2820) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  56. Patent 8859562 expires

    Listed method-of-use patent (U-2819) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  57. Patent 8859562 expires

    Listed method-of-use patent (U-3695) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  58. Patent 8859562 expires

    Listed method-of-use patent (U-2832) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  59. Patent 8859562 expires

    Listed method-of-use patent (U-3333) expiration.

    Aug 04, 2031

    in 5 yr 2 mo

  60. Patent 11970530 expires

    Listed method-of-use patent (U-3929) expiration.

    Oct 25, 2041

    in 15 yr 7 mo

  61. Patent 11970530 expires

    Listed method-of-use patent (U-3930) expiration.

    Oct 25, 2041

    in 15 yr 7 mo

  62. Patent 11970530 expires

    Listed method-of-use patent (U-3931) expiration.

    Oct 25, 2041

    in 15 yr 7 mo

Pharmaceutical detail

Active ingredient

OLAPARIB

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 208558

Product number

001

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 (3)

  • I-914New indication exclusivity (3 years)

    May 31, 2026

    19 d ago

  • ODE-283Orphan-drug exclusivity (7 years)

    Dec 27, 2026

    in 6 mo

  • ODE-306Orphan-drug exclusivity (7 years)

    May 08, 2027

    in 11 mo

Listed patents (57)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8071579Aug 12, 2027in 1 yr 2 mo
U-3631
8071579Aug 12, 2027in 1 yr 2 mo
U-2716
8071579Aug 12, 2027in 1 yr 2 mo
U-2483
8071579Aug 12, 2027in 1 yr 2 mo
U-2482
8071579Aug 12, 2027in 1 yr 2 mo
U-3695
8071579Aug 12, 2027in 1 yr 2 mo
U-2820
8071579Aug 12, 2027in 1 yr 2 mo
U-2824
8071579Aug 12, 2027in 1 yr 2 mo
U-2833
8071579Aug 12, 2027in 1 yr 2 mo
U-2823
8071579Aug 12, 2027in 1 yr 2 mo
U-2832
8071579Aug 12, 2027in 1 yr 2 mo
U-2480
8071579Aug 12, 2027in 1 yr 2 mo
U-2821
8071579Aug 12, 2027in 1 yr 2 mo
U-2819
8071579Aug 12, 2027in 1 yr 2 mo
U-2822
8071579Aug 12, 2027in 1 yr 2 mo
U-3333
8143241Aug 12, 2027in 1 yr 2 mo
U-2482
8143241Aug 12, 2027in 1 yr 2 mo
U-2480
8143241Aug 12, 2027in 1 yr 2 mo
U-2716
8143241Aug 12, 2027in 1 yr 2 mo
U-2483
8143241Aug 12, 2027in 1 yr 2 mo
U-3631
8143241Aug 12, 2027in 1 yr 2 mo
U-2824
8143241Aug 12, 2027in 1 yr 2 mo
U-2823
8143241Aug 12, 2027in 1 yr 2 mo
U-2821
8143241Aug 12, 2027in 1 yr 2 mo
U-2819
8143241Aug 12, 2027in 1 yr 2 mo
U-2820
8143241Aug 12, 2027in 1 yr 2 mo
U-2822
8143241Aug 12, 2027in 1 yr 2 mo
U-3695
8143241Aug 12, 2027in 1 yr 2 mo
U-2832
8143241Aug 12, 2027in 1 yr 2 mo
U-2833
8143241Aug 12, 2027in 1 yr 2 mo
U-3333
7449464Sep 08, 2027in 1 yr 3 mo
SubstanceProduct
11633396Oct 07, 2029in 3 yr 4 mo
Product
11975001Oct 07, 2029in 3 yr 4 mo
Product
12048695Oct 07, 2029in 3 yr 4 mo
Product
12144810Oct 07, 2029in 3 yr 4 mo
Product
12178816Oct 07, 2029in 3 yr 4 mo
Product
8475842Dec 31, 2029in 3 yr 7 mo
Product
8859562Aug 04, 2031in 5 yr 2 mo
U-2101
8859562Aug 04, 2031in 5 yr 2 mo
U-2483
8859562Aug 04, 2031in 5 yr 2 mo
U-2482
8859562Aug 04, 2031in 5 yr 2 mo
U-2716
8859562Aug 04, 2031in 5 yr 2 mo
U-2480
8859562Aug 04, 2031in 5 yr 2 mo
U-3631
8859562Aug 04, 2031in 5 yr 2 mo
U-2103
8859562Aug 04, 2031in 5 yr 2 mo
U-2833
8859562Aug 04, 2031in 5 yr 2 mo
U-2822
8859562Aug 04, 2031in 5 yr 2 mo
U-2821
8859562Aug 04, 2031in 5 yr 2 mo
U-2823
8859562Aug 04, 2031in 5 yr 2 mo
U-2824
8859562Aug 04, 2031in 5 yr 2 mo
U-2820
8859562Aug 04, 2031in 5 yr 2 mo
U-2819
8859562Aug 04, 2031in 5 yr 2 mo
U-3695
8859562Aug 04, 2031in 5 yr 2 mo
U-2832
8859562Aug 04, 2031in 5 yr 2 mo
U-3333
11970530Oct 25, 2041in 15 yr 7 mo
U-3929
11970530Oct 25, 2041in 15 yr 7 mo
U-3930
11970530Oct 25, 2041in 15 yr 7 mo
U-3931
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