Assyro AI

Orange Book product · Brand (NDA)

HETLIOZ LQ

TASIMELTEON

Brand (NDA)NDA 214517RX VANDA PHARMS INC
View TASIMELTEON familyOpen on FDA Orange Book

At a glance

Dec 01, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

27

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 01, 2020

    5 yr 8 mo ago

  2. Today

  3. Exclusivity ends · ODE-329

    Orphan-drug exclusivity (7 years)

    Dec 01, 2027

    in 1 yr 6 mo

  4. Patent 10149829 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  5. Patent 10610510 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  6. Patent 10980770 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  7. Patent 11285129 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  8. Patent 11633377 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  9. Patent 11826339 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  10. Patent 11833130 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  11. Patent 11850229 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  12. Patent 11918557 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  13. Patent 12201604 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  14. Patent 9539234 expires

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

    Jan 25, 2033

    in 6 yr 8 mo

  15. Patent 11918556 expires

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

    Apr 07, 2033

    in 6 yr 11 mo

  16. Patent 9730910 expires

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

    May 17, 2034

    in 8 yr

  17. Patent 10610511 expires

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

    Oct 10, 2034

    in 8 yr 5 mo

  18. Patent 11141400 expires

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

    Oct 10, 2034

    in 8 yr 5 mo

  19. Patent 11786502 expires

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

    Oct 10, 2034

    in 8 yr 5 mo

  20. Patent 10071977 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  21. Patent 10829465 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  22. Patent 11566011 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  23. Patent 11760740 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  24. Patent 12049457 expires

    Listed drug substance patent expiration.

    Feb 12, 2035

    in 8 yr 9 mo

  25. Patent 10376487 expires

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

    Jul 27, 2035

    in 9 yr 3 mo

  26. Patent 10179119 expires

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

    Aug 29, 2035

    in 9 yr 4 mo

  27. Patent 11266622 expires

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

    Aug 29, 2035

    in 9 yr 4 mo

  28. Patent 11202770 expires

    Listed drug product patent expiration.

    Dec 11, 2040

    in 14 yr 8 mo

  29. Patent 12447141 expires

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

    Dec 11, 2040

    in 14 yr 8 mo

  30. 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

4MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 214517

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-329Orphan-drug exclusivity (7 years)

    Dec 01, 2027

    in 1 yr 6 mo

Listed patents (27)

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-3006
10610510Jan 25, 2033in 6 yr 8 mo
U-3009
10980770Jan 25, 2033in 6 yr 8 mo
U-3106
11285129Jan 25, 2033in 6 yr 8 mo
U-3342
11633377Jan 25, 2033in 6 yr 8 mo
U-3003
11826339Jan 25, 2033in 6 yr 8 mo
U-3342
11833130Jan 25, 2033in 6 yr 8 mo
U-3003
11850229Jan 25, 2033in 6 yr 8 mo
U-3342
11918557Jan 25, 2033in 6 yr 8 mo
U-3003
12201604Jan 25, 2033in 6 yr 8 mo
U-3003
9539234Jan 25, 2033in 6 yr 8 mo
U-3004
11918556Apr 07, 2033in 6 yr 11 mo
U-3342
9730910May 17, 2034in 8 yr
U-3005
10610511Oct 10, 2034in 8 yr 5 mo
U-3007
11141400Oct 10, 2034in 8 yr 5 mo
U-3007
11786502Oct 10, 2034in 8 yr 5 mo
U-3007
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-3007
10179119Aug 29, 2035in 9 yr 4 mo
U-3003
11266622Aug 29, 2035in 9 yr 4 mo
U-3003
11202770Dec 11, 2040in 14 yr 8 mo
Product
12447141Dec 11, 2040in 14 yr 8 mo
U-3003
11759446Feb 21, 2041in 14 yr 11 mo
U-3003
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