Assyro AI
Orange Book product · Brand (NDA)

Austedo XR

Deutetrabenazine

Brand (NDA)NDA 216354RLD Teva
Approved
Feb 17, 2023
Application
Brand (NDA)
TE code
Not listed
Listed patents
30
Austedo XR (Deutetrabenazine) is Teva's brand-name drug, approved by the FDA under NDA 216354 in 2023. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 1 approved generic share this drug's active ingredient. The FDA Orange Book lists 30 patents against it, the last expiring 2041.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 17, 2023

    3 yr 5 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 9550780 expires

    Listed drug substance patent expiration.

    Sep 18, 2033

    in 7 yr 3 mo

  6. Patent 9550780 expires

    Listed drug substance patent expiration.

    Sep 18, 2033

    in 7 yr 3 mo

  7. Patent 9550780*PED expires

    Listed listed patent expiration.

    Mar 18, 2034

    in 7 yr 10 mo

  8. Patent 10959996 expires

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

    Mar 07, 2036

    in 9 yr 10 mo

  9. Patent 11357772 expires

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

    Mar 07, 2036

    in 9 yr 10 mo

  10. Patent 11357772 expires

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

    Mar 07, 2036

    in 9 yr 10 mo

  11. Patent 11446291 expires

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

    Mar 07, 2036

    in 9 yr 10 mo

  12. Patent 11564917 expires

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

    Mar 07, 2036

    in 9 yr 10 mo

  13. Patent 11648244 expires

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

    Mar 07, 2036

    in 9 yr 10 mo

  14. Patent 12016858 expires

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

    Mar 07, 2036

    in 9 yr 10 mo

  15. Patent 12016858 expires

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

    Mar 07, 2036

    in 9 yr 10 mo

  16. Patent 10959996*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  17. Patent 11357772*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  18. Patent 11446291*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  19. Patent 11564917*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  20. Patent 11648244*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  21. Patent 12016858*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

  22. Patent 11179386 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 10 mo

  23. Patent 11179386 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 10 mo

  24. Patent 11813232 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 10 mo

  25. Patent 11179386*PED expires

    Listed listed patent expiration.

    Sep 15, 2038

    in 12 yr 4 mo

  26. Patent 11813232*PED expires

    Listed listed patent expiration.

    Sep 15, 2038

    in 12 yr 4 mo

  27. Patent 11311488 expires

    Listed drug product patent expiration.

    Jun 10, 2041

    in 15 yr 2 mo

  28. Patent 11311488 expires

    Listed drug product patent expiration.

    Jun 10, 2041

    in 15 yr 2 mo

  29. Patent 12589075 expires

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

    Jun 10, 2041

    in 15 yr 2 mo

  30. Patent 12589075 expires

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

    Jun 10, 2041

    in 15 yr 2 mo

  31. Patent 12599598 expires

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

    Jun 10, 2041

    in 15 yr 2 mo

  32. Patent 12599598 expires

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

    Jun 10, 2041

    in 15 yr 2 mo

Protection horizon

Patent & exclusivity timeline

202620282030203220342036203820402042TodayPatent 8524733 — 2031-04-03Patent 8524733Patent 8524733*PED — 2031-10-03Patent 8524733*PEDPatent 9550780 — 2033-09-18Patent 9550780Patent 9550780 — 2033-09-18Patent 9550780Patent 9550780*PED — 2034-03-18Patent 9550780*PEDPatent 10959996 — 2036-03-07Patent 10959996Patent 11357772 — 2036-03-07Patent 11357772Patent 11357772 — 2036-03-07Patent 11357772Patent 11446291 — 2036-03-07Patent 11446291Patent 11564917 — 2036-03-07Patent 11564917Patent 11648244 — 2036-03-07Patent 11648244Patent 12016858 — 2036-03-07Patent 12016858Patent 12016858 — 2036-03-07Patent 12016858Patent 10959996*PED — 2036-09-07Patent 10959996*PEDPatent 11357772*PED — 2036-09-07Patent 11357772*PEDPatent 11446291*PED — 2036-09-07Patent 11446291*PEDPatent 11564917*PED — 2036-09-07Patent 11564917*PEDPatent 11648244*PED — 2036-09-07Patent 11648244*PEDPatent 12016858*PED — 2036-09-07Patent 12016858*PEDPatent 11179386 — 2038-03-15Patent 11179386Patent 11179386 — 2038-03-15Patent 11179386Patent 11813232 — 2038-03-15Patent 11813232Patent 11179386*PED — 2038-09-15Patent 11179386*PEDPatent 11813232*PED — 2038-09-15Patent 11813232*PEDPatent 11311488 — 2041-06-10Patent 11311488Patent 11311488 — 2041-06-10Patent 11311488Patent 12589075 — 2041-06-10Patent 12589075Patent 12589075 — 2041-06-10Patent 12589075Patent 12599598 — 2041-06-10Patent 12599598Patent 12599598 — 2041-06-10Patent 12599598
Patent expiryExclusivity endToday
FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

DEUTETRABENAZINE

Strength

12MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 216354

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Same application

Other strengths in NDA 216354

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Deutetrabenazine family
Orange Book patent file

Listed patents

Listed patents (30)

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
9550780Sep 18, 2033in 7 yr 3 mo
SubstanceProductU-3055
9550780Sep 18, 2033in 7 yr 3 mo
SubstanceProductU-1995
9550780*PEDMar 18, 2034in 7 yr 10 mo
10959996Mar 07, 2036in 9 yr 10 mo
U-3055
11357772Mar 07, 2036in 9 yr 10 mo
U-3055
11357772Mar 07, 2036in 9 yr 10 mo
U-1995
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-3055
12016858Mar 07, 2036in 9 yr 10 mo
U-1995
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 10 mo
ProductU-3055
11179386Mar 15, 2038in 11 yr 10 mo
ProductU-1995
11813232Mar 15, 2038in 11 yr 10 mo
Product
11179386*PEDSep 15, 2038in 12 yr 4 mo
11813232*PEDSep 15, 2038in 12 yr 4 mo
11311488Jun 10, 2041in 15 yr 2 mo
ProductU-3055
11311488Jun 10, 2041in 15 yr 2 mo
ProductU-1995
12589075Jun 10, 2041in 15 yr 2 mo
U-3055
12589075Jun 10, 2041in 15 yr 2 mo
U-1995
12599598Jun 10, 2041in 15 yr 2 mo
U-3055
12599598Jun 10, 2041in 15 yr 2 mo
U-1995

Austedo XR — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Deutetrabenazine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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