Assyro AI
Orange Book product · Brand (NDA)

Austedo

Deutetrabenazine

Brand (NDA)NDA 208082RLD Teva Branded Pharm
Approved
Apr 03, 2017
Application
Brand (NDA)
TE code
Not listed
Listed patents
32
Austedo (Deutetrabenazine) is Teva Branded Pharm's brand-name drug, approved by the FDA under NDA 208082 in 2017. 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 32 patents against it, the last expiring 2038.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 03, 2017

    9 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 11666566 expires

    Listed drug product patent expiration.

    Sep 18, 2033

    in 7 yr 3 mo

  6. Patent 9233959 expires

    Listed drug product patent expiration.

    Sep 18, 2033

    in 7 yr 3 mo

  7. Patent 9296739 expires

    Listed drug product patent expiration.

    Sep 18, 2033

    in 7 yr 3 mo

  8. Patent 9550780 expires

    Listed drug substance patent expiration.

    Sep 18, 2033

    in 7 yr 3 mo

  9. Patent 9550780 expires

    Listed drug substance patent expiration.

    Sep 18, 2033

    in 7 yr 3 mo

  10. Patent 9814708 expires

    Listed drug product patent expiration.

    Sep 18, 2033

    in 7 yr 3 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 10 mo

  31. Patent 11179386 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 10 mo

  32. Patent 11813232 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 10 mo

  33. Patent 11179386*PED expires

    Listed listed patent expiration.

    Sep 15, 2038

    in 12 yr 4 mo

  34. Patent 11813232*PED expires

    Listed listed patent expiration.

    Sep 15, 2038

    in 12 yr 4 mo

Protection horizon

Patent & exclusivity timeline

2026202820302032203420362038TodayPatent 8524733 — 2031-04-03Patent 8524733Patent 8524733*PED — 2031-10-03Patent 8524733*PEDPatent 11666566 — 2033-09-18Patent 11666566Patent 9233959 — 2033-09-18Patent 9233959Patent 9296739 — 2033-09-18Patent 9296739Patent 9550780 — 2033-09-18Patent 9550780Patent 9550780 — 2033-09-18Patent 9550780Patent 9814708 — 2033-09-18Patent 9814708Patent 11666566*PED — 2034-03-18Patent 11666566*PEDPatent 9233959*PED — 2034-03-18Patent 9233959*PEDPatent 9296739*PED — 2034-03-18Patent 9296739*PEDPatent 9550780*PED — 2034-03-18Patent 9550780*PEDPatent 9814708*PED — 2034-03-18Patent 9814708*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*PED
Patent expiryExclusivity endToday
FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

DEUTETRABENAZINE

Strength

9MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 208082

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Same application

Other strengths in NDA 208082

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 (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 3 mo
Product
9233959Sep 18, 2033in 7 yr 3 mo
Product
9296739Sep 18, 2033in 7 yr 3 mo
Product
9550780Sep 18, 2033in 7 yr 3 mo
SubstanceProductU-1995
9550780Sep 18, 2033in 7 yr 3 mo
SubstanceProductU-3055
9814708Sep 18, 2033in 7 yr 3 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 10 mo
ProductU-1995
11179386Mar 15, 2038in 11 yr 10 mo
ProductU-3055
11813232Mar 15, 2038in 11 yr 10 mo
Product
11179386*PEDSep 15, 2038in 12 yr 4 mo
11813232*PEDSep 15, 2038in 12 yr 4 mo

Austedo — 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.

Related FDA reference tools

Agent CTA Background

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

Book a Demo