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Orange Book drug · Brand (NDA)

Austedo XR

Deutetrabenazine

RLDNDA 216354 8 strengths Teva
Approved
Feb 17, 2023
Strengths
8
Listed patents
23

What does the FDA Orange Book show for Austedo XR?

Austedo XR contains Deutetrabenazine and is the new drug FDA Orange Book record for NDA 216354. The application has 8 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 216354

New drug application identity from the Orange Book snapshot.

Application holder
Teva Neuroscience Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
8

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
23

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0016MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
00212MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
00324MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
00430MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
00536MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
00642MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
00748MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLDRS
00818MGTABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Teva Neuroscience Inc

The Orange Book identifies this organization as the applicant responsible for NDA 216354.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

8 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

23 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Jun 10, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

1 other ANDA and 1 other NDA found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 216354 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet, Extended Release · Oral

Deutetrabenazine

1 application
Product rows
8
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-216354

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

8 approved presentations · NDA 216354
RLD
Strength
6MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    3 yr 6 mo ago

  2. Today

  3. Patent 8524733 expires

    Listed drug substance patent expiration.

    in 4 yr 9 mo

  4. Patent 8524733*PED expires

    Listed listed patent expiration.

    in 5 yr 3 mo

  5. Patent 9550780 expires

    Listed drug substance patent expiration.

    in 7 yr 3 mo

  6. Patent 9550780 expires

    Listed drug substance patent expiration.

    in 7 yr 3 mo

  7. Patent 9550780*PED expires

    Listed listed patent expiration.

    in 7 yr 9 mo

  8. Patent 10959996 expires

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

    in 9 yr 9 mo

  9. Patent 11357772 expires

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

    in 9 yr 9 mo

  10. Patent 11357772 expires

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

    in 9 yr 9 mo

  11. Patent 11446291 expires

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

    in 9 yr 9 mo

  12. Patent 11564917 expires

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

    in 9 yr 9 mo

  13. Patent 11648244 expires

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

    in 9 yr 9 mo

  14. Patent 12016858 expires

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

    in 9 yr 9 mo

  15. Patent 12016858 expires

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

    in 9 yr 9 mo

  16. Patent 10959996*PED expires

    Listed listed patent expiration.

    in 10 yr 3 mo

  17. Patent 11357772*PED expires

    Listed listed patent expiration.

    in 10 yr 3 mo

  18. Patent 11446291*PED expires

    Listed listed patent expiration.

    in 10 yr 3 mo

  19. Patent 11564917*PED expires

    Listed listed patent expiration.

    in 10 yr 3 mo

  20. Patent 11648244*PED expires

    Listed listed patent expiration.

    in 10 yr 3 mo

  21. Patent 12016858*PED expires

    Listed listed patent expiration.

    in 10 yr 3 mo

  22. Patent 11179386 expires

    Listed drug product patent expiration.

    in 11 yr 10 mo

  23. Patent 11179386 expires

    Listed drug product patent expiration.

    in 11 yr 10 mo

  24. Patent 11813232 expires

    Listed drug product patent expiration.

    in 11 yr 10 mo

  25. Patent 11179386*PED expires

    Listed listed patent expiration.

    in 12 yr 4 mo

  26. Patent 11813232*PED expires

    Listed listed patent expiration.

    in 12 yr 4 mo

  27. Patent 11311488 expires

    Listed drug product patent expiration.

    in 15 yr 1 mo

  28. Patent 11311488 expires

    Listed drug product patent expiration.

    in 15 yr 1 mo

  29. Patent 12589075 expires

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

    in 15 yr 1 mo

  30. Patent 12589075 expires

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

    in 15 yr 1 mo

  31. Patent 12599598 expires

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

    in 15 yr 1 mo

  32. Patent 12599598 expires

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

    in 15 yr 1 mo

Patent & exclusivity timeline

Protection horizon
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

Pharmaceutical detail

FDA product record

Active ingredient

DEUTETRABENAZINE

Strength

6MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 216354

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8524733in 4 yr 9 mo
SubstanceProduct
8524733*PEDin 5 yr 3 mo
9550780in 7 yr 3 mo
SubstanceProductU-1995
9550780in 7 yr 3 mo
SubstanceProductU-3055
9550780*PEDin 7 yr 9 mo
10959996in 9 yr 9 mo
U-3055
11357772in 9 yr 9 mo
U-1995
11357772in 9 yr 9 mo
U-3055
11446291in 9 yr 9 mo
U-1995
11564917in 9 yr 9 mo
U-1995
11648244in 9 yr 9 mo
U-1995
12016858in 9 yr 9 mo
U-1995
12016858in 9 yr 9 mo
U-3055
10959996*PEDin 10 yr 3 mo
11357772*PEDin 10 yr 3 mo
11446291*PEDin 10 yr 3 mo
11564917*PEDin 10 yr 3 mo
11648244*PEDin 10 yr 3 mo
12016858*PEDin 10 yr 3 mo
11179386in 11 yr 10 mo
ProductU-1995
11179386in 11 yr 10 mo
ProductU-3055
11813232in 11 yr 10 mo
Product
11179386*PEDin 12 yr 4 mo
11813232*PEDin 12 yr 4 mo
11311488in 15 yr 1 mo
ProductU-1995
11311488in 15 yr 1 mo
ProductU-3055
12589075in 15 yr 1 mo
U-3055
12589075in 15 yr 1 mo
U-1995
12599598in 15 yr 1 mo
U-3055
12599598in 15 yr 1 mo
U-1995

Active-ingredient family

Brand + generics

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

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Austedo XR: frequently asked questions

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

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 216354 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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