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DEUTETRABENAZINE, NDA 216354

The patents and exclusivities FDA's Orange Book lists for NDA 216354 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured
14 October 2026
Paragraph IV list captured
17 October 2026
Last checked
30 October 2026
Data-branch commit
dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the appDEUTETRABENAZINE in the molecule app

Listed protection

Listed dates run from 3 Apr 2031 to 10 Jun 2041, each by its own rule; no one date stands for this product.

Earliest listed date
3 Apr 2031US 8,524,733, substance and product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008 · patent.txt lines 18,550, 18,580, 18,610, 18,640, 18,670, 18,700, 18,730, 18,760
Latest listed date
10 Jun 2041US 12,599,598, use patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008 · patent.txt lines 18,548, 18,578, 18,608, 18,638, 18,668, 18,698, 18,728, 18,758
Latest substance patent
18 Mar 2034US 9,550,780 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005, 006, 007, 008 · patent.txt lines 18,551, 18,581, 18,611, 18,641, 18,671, 18,701, 18,731, 18,761
Latest listed patent
10 Jun 2041US 12,599,598, use patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008 · patent.txt lines 18,548, 18,578, 18,608, 18,638, 18,668, 18,698, 18,728, 18,758
Latest exclusivity
None listed

144 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 216354, as listed. The sections below name products by these numbers.

  • Product 001 · AUSTEDO XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    6MG
    Approval date as listed
    17 Feb 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 002 · AUSTEDO XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    12MG
    Approval date as listed
    17 Feb 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 003 · AUSTEDO XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    24MG
    Approval date as listed
    17 Feb 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 004 · AUSTEDO XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    30MG
    Approval date as listed
    29 May 2024
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 005 · AUSTEDO XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    36MG
    Approval date as listed
    29 May 2024
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 006 · AUSTEDO XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    42MG
    Approval date as listed
    29 May 2024
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 007 · AUSTEDO XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    48MG
    Approval date as listed
    29 May 2024
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 008 · AUSTEDO XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    18MG
    Approval date as listed
    1 Jul 2024
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

30 entries from 240 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 8,524,733, substance and product patent

    patent.txt lines 18,550, 18,580, 18,610, 18,640, 18,670, 18,700, 18,730, 18,760
    Expiry as listed
    3 Apr 2031
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 8,524,733 with pediatric exclusivity, as listed

    patent.txt lines 18,549, 18,579, 18,609, 18,639, 18,669, 18,699, 18,729, 18,759
    Expiry as listed
    3 Oct 2031
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 9,550,780, substance and product and use patent

    patent.txt lines 18,552, 18,582, 18,612, 18,642, 18,672, 18,702, 18,732, 18,762
    Expiry as listed
    18 Sep 2033
    Rule
    R1
    Flags
    substance · product · use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 9,550,780, substance and product and use patent

    patent.txt lines 18,553, 18,583, 18,613, 18,643, 18,673, 18,703, 18,733, 18,763
    Expiry as listed
    18 Sep 2033
    Rule
    R1
    Flags
    substance · product · use code U-3055
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 9,550,780 with pediatric exclusivity, as listed

    patent.txt lines 18,551, 18,581, 18,611, 18,641, 18,671, 18,701, 18,731, 18,761
    Expiry as listed
    18 Mar 2034
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 10,959,996, use patent

    patent.txt lines 18,525, 18,555, 18,585, 18,615, 18,645, 18,675, 18,705, 18,735
    Expiry as listed
    7 Mar 2036
    Rule
    R1
    Flags
    use code U-3055
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,357,772, use patent

    patent.txt lines 18,532, 18,562, 18,592, 18,622, 18,652, 18,682, 18,712, 18,742
    Expiry as listed
    7 Mar 2036
    Rule
    R1
    Flags
    use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,357,772, use patent

    patent.txt lines 18,533, 18,563, 18,593, 18,623, 18,653, 18,683, 18,713, 18,743
    Expiry as listed
    7 Mar 2036
    Rule
    R1
    Flags
    use code U-3055
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,446,291, use patent

    patent.txt lines 18,535, 18,565, 18,595, 18,625, 18,655, 18,685, 18,715, 18,745
    Expiry as listed
    7 Mar 2036
    Rule
    R1
    Flags
    use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,564,917, use patent

    patent.txt lines 18,537, 18,567, 18,597, 18,627, 18,657, 18,687, 18,717, 18,747
    Expiry as listed
    7 Mar 2036
    Rule
    R1
    Flags
    use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,648,244, use patent

    patent.txt lines 18,539, 18,569, 18,599, 18,629, 18,659, 18,689, 18,719, 18,749
    Expiry as listed
    7 Mar 2036
    Rule
    R1
    Flags
    use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 12,016,858, use patent

    patent.txt lines 18,543, 18,573, 18,603, 18,633, 18,663, 18,693, 18,723, 18,753
    Expiry as listed
    7 Mar 2036
    Rule
    R1
    Flags
    use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 12,016,858, use patent

    patent.txt lines 18,544, 18,574, 18,604, 18,634, 18,664, 18,694, 18,724, 18,754
    Expiry as listed
    7 Mar 2036
    Rule
    R1
    Flags
    use code U-3055
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 10,959,996 with pediatric exclusivity, as listed

    patent.txt lines 18,524, 18,554, 18,584, 18,614, 18,644, 18,674, 18,704, 18,734
    Expiry as listed
    7 Sep 2036
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,357,772 with pediatric exclusivity, as listed

    patent.txt lines 18,531, 18,561, 18,591, 18,621, 18,651, 18,681, 18,711, 18,741
    Expiry as listed
    7 Sep 2036
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,446,291 with pediatric exclusivity, as listed

    patent.txt lines 18,534, 18,564, 18,594, 18,624, 18,654, 18,684, 18,714, 18,744
    Expiry as listed
    7 Sep 2036
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,564,917 with pediatric exclusivity, as listed

    patent.txt lines 18,536, 18,566, 18,596, 18,626, 18,656, 18,686, 18,716, 18,746
    Expiry as listed
    7 Sep 2036
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,648,244 with pediatric exclusivity, as listed

    patent.txt lines 18,538, 18,568, 18,598, 18,628, 18,658, 18,688, 18,718, 18,748
    Expiry as listed
    7 Sep 2036
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 12,016,858 with pediatric exclusivity, as listed

    patent.txt lines 18,542, 18,572, 18,602, 18,632, 18,662, 18,692, 18,722, 18,752
    Expiry as listed
    7 Sep 2036
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,179,386, product and use patent

    patent.txt lines 18,527, 18,557, 18,587, 18,617, 18,647, 18,677, 18,707, 18,737
    Expiry as listed
    15 Mar 2038
    Rule
    R1
    Flags
    product · use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,179,386, product and use patent

    patent.txt lines 18,528, 18,558, 18,588, 18,618, 18,648, 18,678, 18,708, 18,738
    Expiry as listed
    15 Mar 2038
    Rule
    R1
    Flags
    product · use code U-3055
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,813,232, product patent

    patent.txt lines 18,541, 18,571, 18,601, 18,631, 18,661, 18,691, 18,721, 18,751
    Expiry as listed
    15 Mar 2038
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,179,386 with pediatric exclusivity, as listed

    patent.txt lines 18,526, 18,556, 18,586, 18,616, 18,646, 18,676, 18,706, 18,736
    Expiry as listed
    15 Sep 2038
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,813,232 with pediatric exclusivity, as listed

    patent.txt lines 18,540, 18,570, 18,600, 18,630, 18,660, 18,690, 18,720, 18,750
    Expiry as listed
    15 Sep 2038
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,311,488, product and use patent

    patent.txt lines 18,529, 18,559, 18,589, 18,619, 18,649, 18,679, 18,709, 18,739
    Expiry as listed
    10 Jun 2041
    Rule
    R1
    Flags
    product · use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 11,311,488, product and use patent

    patent.txt lines 18,530, 18,560, 18,590, 18,620, 18,650, 18,680, 18,710, 18,740
    Expiry as listed
    10 Jun 2041
    Rule
    R1
    Flags
    product · use code U-3055
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 12,589,075, use patent

    patent.txt lines 18,545, 18,575, 18,605, 18,635, 18,665, 18,695, 18,725, 18,755
    Expiry as listed
    10 Jun 2041
    Rule
    R1
    Flags
    use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 12,589,075, use patent

    patent.txt lines 18,546, 18,576, 18,606, 18,636, 18,666, 18,696, 18,726, 18,756
    Expiry as listed
    10 Jun 2041
    Rule
    R1
    Flags
    use code U-3055
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 12,599,598, use patent

    patent.txt lines 18,547, 18,577, 18,607, 18,637, 18,667, 18,697, 18,727, 18,757
    Expiry as listed
    10 Jun 2041
    Rule
    R1
    Flags
    use code U-1995
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

  • US 12,599,598, use patent

    patent.txt lines 18,548, 18,578, 18,608, 18,638, 18,668, 18,698, 18,728, 18,758
    Expiry as listed
    10 Jun 2041
    Rule
    R1
    Flags
    use code U-3055
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008

Listed exclusivities

Each exclusivity FDA lists for NDA 216354, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 216354.

Paragraph IV list rows giving NDA 216354

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 216354, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 216354

  • Deutetrabenazine · Extended-release Tablets · 48 mg

    RLD/NDA as listed: Austedo XR 216354
    First PIV submission
    8 Jun 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2041

  • Deutetrabenazine · Extended-release Tablets · 6 mg, 12 mg and 24 mg

    RLD/NDA as listed: Austedo XR 216354
    First PIV submission
    2 Mar 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2041

  • Deutetrabenazine New · Extended-release Tablets · 18 mg

    RLD/NDA as listed: Austedo XR 216354
    First PIV submission
    11 Sep 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2041

Notes from the trace

  • R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week