Assyro AI

Orange Book product · Brand (NDA)

AUSTEDO

DEUTETRABENAZINE

Brand (NDA)NDA 208082RX TEVA BRANDED PHARM
View DEUTETRABENAZINE familyOpen on FDA Orange Book

At a glance

Apr 03, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

32

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 03, 2017

    9 yr 4 mo ago

  2. Today

  3. Patent 8524733 expires

    Listed drug substance patent expiration.

    Apr 03, 2031

    in 4 yr 10 mo

  4. Patent 8524733*PED expires

    Listed listed patent expiration.

    Oct 03, 2031

    in 5 yr 4 mo

  5. Patent 11666566 expires

    Listed drug product patent expiration.

    Sep 18, 2033

    in 7 yr 4 mo

  6. Patent 9233959 expires

    Listed drug product patent expiration.

    Sep 18, 2033

    in 7 yr 4 mo

  7. Patent 9296739 expires

    Listed drug product patent expiration.

    Sep 18, 2033

    in 7 yr 4 mo

  8. Patent 9550780 expires

    Listed drug substance patent expiration.

    Sep 18, 2033

    in 7 yr 4 mo

  9. Patent 9550780 expires

    Listed drug substance patent expiration.

    Sep 18, 2033

    in 7 yr 4 mo

  10. Patent 9814708 expires

    Listed drug product patent expiration.

    Sep 18, 2033

    in 7 yr 4 mo

  11. Patent 11666566*PED expires

    Listed listed patent expiration.

    Mar 18, 2034

    in 7 yr 10 mo

  12. Patent 9233959*PED expires

    Listed listed patent expiration.

    Mar 18, 2034

    in 7 yr 10 mo

  13. Patent 9296739*PED expires

    Listed listed patent expiration.

    Mar 18, 2034

    in 7 yr 10 mo

  14. Patent 9550780*PED expires

    Listed listed patent expiration.

    Mar 18, 2034

    in 7 yr 10 mo

  15. Patent 9814708*PED expires

    Listed listed patent expiration.

    Mar 18, 2034

    in 7 yr 10 mo

  16. Patent 10959996 expires

    Listed method-of-use patent (U-3055) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

  17. Patent 11357772 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

  18. Patent 11357772 expires

    Listed method-of-use patent (U-3055) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

  19. Patent 11446291 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

  20. Patent 11564917 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

  21. Patent 11648244 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

  22. Patent 12016858 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

  23. Patent 12016858 expires

    Listed method-of-use patent (U-3055) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

  24. Patent 10959996*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  25. Patent 11357772*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  26. Patent 11446291*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  27. Patent 11564917*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  28. Patent 11648244*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  29. Patent 12016858*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  30. Patent 11179386 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 11 mo

  31. Patent 11179386 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 11 mo

  32. Patent 11813232 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 11 mo

  33. Patent 11179386*PED expires

    Listed listed patent expiration.

    Sep 15, 2038

    in 12 yr 5 mo

  34. Patent 11813232*PED expires

    Listed listed patent expiration.

    Sep 15, 2038

    in 12 yr 5 mo

Pharmaceutical detail

Active ingredient

DEUTETRABENAZINE

Strength

6MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 208082

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.

Listed patents (32)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8524733Apr 03, 2031in 4 yr 10 mo
SubstanceProduct
8524733*PEDOct 03, 2031in 5 yr 4 mo
11666566Sep 18, 2033in 7 yr 4 mo
Product
9233959Sep 18, 2033in 7 yr 4 mo
Product
9296739Sep 18, 2033in 7 yr 4 mo
Product
9550780Sep 18, 2033in 7 yr 4 mo
SubstanceProductU-1995
9550780Sep 18, 2033in 7 yr 4 mo
SubstanceProductU-3055
9814708Sep 18, 2033in 7 yr 4 mo
Product
11666566*PEDMar 18, 2034in 7 yr 10 mo
9233959*PEDMar 18, 2034in 7 yr 10 mo
9296739*PEDMar 18, 2034in 7 yr 10 mo
9550780*PEDMar 18, 2034in 7 yr 10 mo
9814708*PEDMar 18, 2034in 7 yr 10 mo
10959996Mar 07, 2036in 9 yr 10 mo
U-3055
11357772Mar 07, 2036in 9 yr 10 mo
U-1995
11357772Mar 07, 2036in 9 yr 10 mo
U-3055
11446291Mar 07, 2036in 9 yr 10 mo
U-1995
11564917Mar 07, 2036in 9 yr 10 mo
U-1995
11648244Mar 07, 2036in 9 yr 10 mo
U-1995
12016858Mar 07, 2036in 9 yr 10 mo
U-1995
12016858Mar 07, 2036in 9 yr 10 mo
U-3055
10959996*PEDSep 07, 2036in 10 yr 4 mo
11357772*PEDSep 07, 2036in 10 yr 4 mo
11446291*PEDSep 07, 2036in 10 yr 4 mo
11564917*PEDSep 07, 2036in 10 yr 4 mo
11648244*PEDSep 07, 2036in 10 yr 4 mo
12016858*PEDSep 07, 2036in 10 yr 4 mo
11179386Mar 15, 2038in 11 yr 11 mo
ProductU-1995
11179386Mar 15, 2038in 11 yr 11 mo
ProductU-3055
11813232Mar 15, 2038in 11 yr 11 mo
Product
11179386*PEDSep 15, 2038in 12 yr 5 mo
11813232*PEDSep 15, 2038in 12 yr 5 mo
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo