Assyro AI

Orange Book product · Brand (NDA)

CREXONT

CARBIDOPA; LEVODOPA

Brand (NDA)NDA 217186RX IMPAX
View CARBIDOPA; LEVODOPA familyOpen on FDA Orange Book

At a glance

Aug 07, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

61

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 07, 2024

    1 yr 11 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    Aug 07, 2027

    in 1 yr 2 mo

  4. Patent 10098845 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  5. Patent 10292935 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  6. Patent 10688058 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  7. Patent 10973769 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  8. Patent 10987313 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  9. Patent 11357733 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  10. Patent 11622941 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  11. Patent 11666538 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  12. Patent 12064521 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  13. Patent 12128141 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  14. Patent 12178918 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  15. Patent 12178919 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  16. Patent 12274793 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  17. Patent 12303605 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  18. Patent 12403099 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  19. Patent 12491164 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  20. Patent 11986449 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  21. Patent 12109185 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  22. Patent 12109185 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  23. Patent 12109185 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  24. Patent 12109185 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  25. Patent 12194150 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  26. Patent 12201596 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  27. Patent 12201596 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  28. Patent 12201596 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  29. Patent 12263148 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  30. Patent 12263148 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  31. Patent 12263148 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  32. Patent 12263148 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  33. Patent 12263149 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  34. Patent 12263149 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  35. Patent 12263149 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  36. Patent 12263149 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  37. Patent 12295931 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  38. Patent 12295931 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  39. Patent 12295931 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  40. Patent 12295931 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  41. Patent 12303481 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  42. Patent 12303481 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  43. Patent 12303481 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  44. Patent 12303481 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  45. Patent 12303482 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  46. Patent 12303482 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  47. Patent 12303482 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  48. Patent 12303482 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  49. Patent 12370163 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  50. Patent 12370163 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  51. Patent 12370163 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  52. Patent 12370163 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  53. Patent 12447139 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  54. Patent 12447139 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  55. Patent 12447139 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  56. Patent 12447139 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  57. Patent 12453710 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  58. Patent 12453710 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  59. Patent 12453710 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  60. Patent 12453710 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  61. Patent 12458616 expires

    Listed method-of-use patent (U-4005) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  62. Patent 12458616 expires

    Listed method-of-use patent (U-4004) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  63. Patent 12458616 expires

    Listed method-of-use patent (U-219) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

  64. Patent 12458616 expires

    Listed method-of-use patent (U-1649) expiration.

    Dec 21, 2041

    in 15 yr 9 mo

Pharmaceutical detail

Active ingredient

CARBIDOPA; LEVODOPA

Strength

87.5MG;350MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 217186

Product number

004

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)

  • NPNew product exclusivity (3 years)

    Aug 07, 2027

    in 1 yr 2 mo

Listed patents (61)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10098845Oct 07, 2034in 8 yr 5 mo
ProductU-219
10292935Oct 07, 2034in 8 yr 5 mo
ProductU-219
10688058Oct 07, 2034in 8 yr 5 mo
ProductU-219
10973769Oct 07, 2034in 8 yr 5 mo
ProductU-219
10987313Oct 07, 2034in 8 yr 5 mo
ProductU-219
11357733Oct 07, 2034in 8 yr 5 mo
Product
11622941Oct 07, 2034in 8 yr 5 mo
Product
11666538Oct 07, 2034in 8 yr 5 mo
ProductU-219
12064521Oct 07, 2034in 8 yr 5 mo
Product
12128141Oct 07, 2034in 8 yr 5 mo
ProductU-219
12178918Oct 07, 2034in 8 yr 5 mo
Product
12178919Oct 07, 2034in 8 yr 5 mo
ProductU-219
12274793Oct 07, 2034in 8 yr 5 mo
Product
12303605Oct 07, 2034in 8 yr 5 mo
Product
12403099Oct 07, 2034in 8 yr 5 mo
Product
12491164Oct 07, 2034in 8 yr 5 mo
Product
11986449Dec 21, 2041in 15 yr 9 mo
U-219
12109185Dec 21, 2041in 15 yr 9 mo
U-1649
12109185Dec 21, 2041in 15 yr 9 mo
U-219
12109185Dec 21, 2041in 15 yr 9 mo
U-4004
12109185Dec 21, 2041in 15 yr 9 mo
U-4005
12194150Dec 21, 2041in 15 yr 9 mo
U-219
12201596Dec 21, 2041in 15 yr 9 mo
U-1649
12201596Dec 21, 2041in 15 yr 9 mo
U-4004
12201596Dec 21, 2041in 15 yr 9 mo
U-4005
12263148Dec 21, 2041in 15 yr 9 mo
U-1649
12263148Dec 21, 2041in 15 yr 9 mo
U-219
12263148Dec 21, 2041in 15 yr 9 mo
U-4004
12263148Dec 21, 2041in 15 yr 9 mo
U-4005
12263149Dec 21, 2041in 15 yr 9 mo
U-1649
12263149Dec 21, 2041in 15 yr 9 mo
U-219
12263149Dec 21, 2041in 15 yr 9 mo
U-4004
12263149Dec 21, 2041in 15 yr 9 mo
U-4005
12295931Dec 21, 2041in 15 yr 9 mo
U-4005
12295931Dec 21, 2041in 15 yr 9 mo
U-4004
12295931Dec 21, 2041in 15 yr 9 mo
U-219
12295931Dec 21, 2041in 15 yr 9 mo
U-1649
12303481Dec 21, 2041in 15 yr 9 mo
U-1649
12303481Dec 21, 2041in 15 yr 9 mo
U-219
12303481Dec 21, 2041in 15 yr 9 mo
U-4004
12303481Dec 21, 2041in 15 yr 9 mo
U-4005
12303482Dec 21, 2041in 15 yr 9 mo
U-4005
12303482Dec 21, 2041in 15 yr 9 mo
U-4004
12303482Dec 21, 2041in 15 yr 9 mo
U-219
12303482Dec 21, 2041in 15 yr 9 mo
U-1649
12370163Dec 21, 2041in 15 yr 9 mo
U-1649
12370163Dec 21, 2041in 15 yr 9 mo
U-219
12370163Dec 21, 2041in 15 yr 9 mo
U-4004
12370163Dec 21, 2041in 15 yr 9 mo
U-4005
12447139Dec 21, 2041in 15 yr 9 mo
U-1649
12447139Dec 21, 2041in 15 yr 9 mo
U-219
12447139Dec 21, 2041in 15 yr 9 mo
U-4004
12447139Dec 21, 2041in 15 yr 9 mo
U-4005
12453710Dec 21, 2041in 15 yr 9 mo
U-4005
12453710Dec 21, 2041in 15 yr 9 mo
U-4004
12453710Dec 21, 2041in 15 yr 9 mo
U-219
12453710Dec 21, 2041in 15 yr 9 mo
U-1649
12458616Dec 21, 2041in 15 yr 9 mo
U-4005
12458616Dec 21, 2041in 15 yr 9 mo
U-4004
12458616Dec 21, 2041in 15 yr 9 mo
U-219
12458616Dec 21, 2041in 15 yr 9 mo
U-1649
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