Assyro AI

Orange Book product · Brand (NDA)

HETLIOZ

TASIMELTEON

Brand (NDA)NDA 205677TE ABRX VANDA PHARMS INC
View TASIMELTEON familyOpen on FDA Orange Book

At a glance

Jan 31, 2014

Approved

Brand (NDA)

Application

AB

TE code

48

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 2014

    12 yr 7 mo ago

  2. Today

  3. Exclusivity ends · ODE-330

    Orphan-drug exclusivity (7 years)

    Dec 01, 2027

    in 1 yr 6 mo

  4. Patent 10149829 expires

    Listed method-of-use patent (U-2477) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  5. Patent 10149829 expires

    Listed method-of-use patent (U-3006) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  6. Patent 10449176 expires

    Listed method-of-use patent (U-2149) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  7. Patent 10610510 expires

    Listed method-of-use patent (U-3009) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  8. Patent 10610510 expires

    Listed method-of-use patent (U-2805) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  9. Patent 10945988 expires

    Listed method-of-use patent (U-2149) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  10. Patent 10980770 expires

    Listed method-of-use patent (U-3106) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  11. Patent 10980770 expires

    Listed method-of-use patent (U-3107) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  12. Patent 11285129 expires

    Listed method-of-use patent (U-3342) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  13. Patent 11285129 expires

    Listed method-of-use patent (U-3343) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  14. Patent 11633377 expires

    Listed method-of-use patent (U-2149) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  15. Patent 11633377 expires

    Listed method-of-use patent (U-3003) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  16. Patent 11826339 expires

    Listed method-of-use patent (U-3342) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  17. Patent 11826339 expires

    Listed method-of-use patent (U-3343) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  18. Patent 11833130 expires

    Listed method-of-use patent (U-2149) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  19. Patent 11833130 expires

    Listed method-of-use patent (U-3003) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  20. Patent 11850229 expires

    Listed method-of-use patent (U-3342) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  21. Patent 11850229 expires

    Listed method-of-use patent (U-3343) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  22. Patent 11918557 expires

    Listed method-of-use patent (U-3003) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  23. Patent 11918557 expires

    Listed method-of-use patent (U-3865) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  24. Patent 12201604 expires

    Listed method-of-use patent (U-3003) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  25. Patent 12201604 expires

    Listed method-of-use patent (U-3865) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  26. Patent 9060995 expires

    Listed method-of-use patent (U-1710) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  27. Patent 9539234 expires

    Listed method-of-use patent (U-1934) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  28. Patent 9539234 expires

    Listed method-of-use patent (U-3004) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  29. Patent 9549913 expires

    Listed method-of-use patent (U-1486) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  30. Patent 9855241 expires

    Listed method-of-use patent (U-2149) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  31. Patent RE46604 expires

    Listed method-of-use patent (U-2147) expiration.

    Jan 25, 2033

    in 6 yr 8 mo

  32. Patent 11918556 expires

    Listed method-of-use patent (U-3342) expiration.

    Apr 07, 2033

    in 6 yr 11 mo

  33. Patent 11918556 expires

    Listed method-of-use patent (U-3343) expiration.

    Apr 07, 2033

    in 6 yr 11 mo

  34. Patent 9730910 expires

    Listed method-of-use patent (U-2085) expiration.

    May 17, 2034

    in 8 yr

  35. Patent 9730910 expires

    Listed method-of-use patent (U-3005) expiration.

    May 17, 2034

    in 8 yr

  36. Patent 10610511 expires

    Listed method-of-use patent (U-3007) expiration.

    Oct 10, 2034

    in 8 yr 5 mo

  37. Patent 10610511 expires

    Listed method-of-use patent (U-2615) expiration.

    Oct 10, 2034

    in 8 yr 5 mo

  38. Patent 11141400 expires

    Listed method-of-use patent (U-2615) expiration.

    Oct 10, 2034

    in 8 yr 5 mo

  39. Patent 11141400 expires

    Listed method-of-use patent (U-3007) expiration.

    Oct 10, 2034

    in 8 yr 5 mo

  40. Patent 11786502 expires

    Listed method-of-use patent (U-3007) expiration.

    Oct 10, 2034

    in 8 yr 5 mo

  41. Patent 11786502 expires

    Listed method-of-use patent (U-3739) expiration.

    Oct 10, 2034

    in 8 yr 5 mo

  42. Patent 10071977 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  43. Patent 10829465 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  44. Patent 11566011 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  45. Patent 11760740 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  46. Patent 12049457 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  47. Patent 10376487 expires

    Listed method-of-use patent (U-2615) expiration.

    Jul 27, 2035

    in 9 yr 3 mo

  48. Patent 10376487 expires

    Listed method-of-use patent (U-3007) expiration.

    Jul 27, 2035

    in 9 yr 3 mo

  49. Patent 10179119 expires

    Listed method-of-use patent (U-3003) expiration.

    Aug 29, 2035

    in 9 yr 4 mo

  50. Patent 11266622 expires

    Listed method-of-use patent (U-3003) expiration.

    Aug 29, 2035

    in 9 yr 4 mo

  51. Patent 11759446 expires

    Listed method-of-use patent (U-3003) expiration.

    Feb 21, 2041

    in 14 yr 11 mo

Pharmaceutical detail

Active ingredient

TASIMELTEON

Strength

20MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

NDA 205677

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)

  • ODE-330Orphan-drug exclusivity (7 years)

    Dec 01, 2027

    in 1 yr 6 mo

Listed patents (48)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10149829Jan 25, 2033in 6 yr 8 mo
U-2477
10149829Jan 25, 2033in 6 yr 8 mo
U-3006
10449176Jan 25, 2033in 6 yr 8 mo
U-2149
10610510Jan 25, 2033in 6 yr 8 mo
U-3009
10610510Jan 25, 2033in 6 yr 8 mo
U-2805
10945988Jan 25, 2033in 6 yr 8 mo
U-2149
10980770Jan 25, 2033in 6 yr 8 mo
U-3106
10980770Jan 25, 2033in 6 yr 8 mo
U-3107
11285129Jan 25, 2033in 6 yr 8 mo
U-3342
11285129Jan 25, 2033in 6 yr 8 mo
U-3343
11633377Jan 25, 2033in 6 yr 8 mo
U-2149
11633377Jan 25, 2033in 6 yr 8 mo
U-3003
11826339Jan 25, 2033in 6 yr 8 mo
U-3342
11826339Jan 25, 2033in 6 yr 8 mo
U-3343
11833130Jan 25, 2033in 6 yr 8 mo
U-2149
11833130Jan 25, 2033in 6 yr 8 mo
U-3003
11850229Jan 25, 2033in 6 yr 8 mo
U-3342
11850229Jan 25, 2033in 6 yr 8 mo
U-3343
11918557Jan 25, 2033in 6 yr 8 mo
U-3003
11918557Jan 25, 2033in 6 yr 8 mo
U-3865
12201604Jan 25, 2033in 6 yr 8 mo
U-3003
12201604Jan 25, 2033in 6 yr 8 mo
U-3865
9060995Jan 25, 2033in 6 yr 8 mo
U-1710
9539234Jan 25, 2033in 6 yr 8 mo
U-1934
9539234Jan 25, 2033in 6 yr 8 mo
U-3004
9549913Jan 25, 2033in 6 yr 8 mo
U-1486
9855241Jan 25, 2033in 6 yr 8 mo
U-2149
RE46604Jan 25, 2033in 6 yr 8 mo
U-2147
11918556Apr 07, 2033in 6 yr 11 mo
U-3342
11918556Apr 07, 2033in 6 yr 11 mo
U-3343
9730910May 17, 2034in 8 yr
U-2085
9730910May 17, 2034in 8 yr
U-3005
10610511Oct 10, 2034in 8 yr 5 mo
U-3007
10610511Oct 10, 2034in 8 yr 5 mo
U-2615
11141400Oct 10, 2034in 8 yr 5 mo
U-2615
11141400Oct 10, 2034in 8 yr 5 mo
U-3007
11786502Oct 10, 2034in 8 yr 5 mo
U-3007
11786502Oct 10, 2034in 8 yr 5 mo
U-3739
10071977Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
10829465Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
11566011Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
11760740Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
12049457Feb 12, 2035in 8 yr 9 mo
SubstanceProduct
10376487Jul 27, 2035in 9 yr 3 mo
U-2615
10376487Jul 27, 2035in 9 yr 3 mo
U-3007
10179119Aug 29, 2035in 9 yr 4 mo
U-3003
11266622Aug 29, 2035in 9 yr 4 mo
U-3003
11759446Feb 21, 2041in 14 yr 11 mo
U-3003
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