Drybench Patent.
BREXPIPRAZOLE, NDA 205422
The patents and exclusivities FDA's Orange Book lists for NDA 205422 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.
Listed protection
Listed dates run from 12 Apr 2026 to 12 Apr 2033, each by its own rule; no one date stands for this product.
- Earliest listed date
- 12 Apr 2026US 8,349,840, product and use patentRule R1 · Products 001, 002, 003, 004, 005, 006 · patent.txt lines 5,310, 5,323, 5,336, 5,349, 5,362, 5,373
- Latest listed date
- 12 Apr 2033US 10,307,419 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005 · patent.txt lines 5,307, 5,320, 5,333, 5,346, 5,359
- Latest substance patent
- 23 Jun 2029US RE48059 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005, 006 · patent.txt lines 5,318, 5,331, 5,344, 5,357, 5,370, 5,381
- Latest listed patent
- 12 Apr 2033US 10,307,419 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005 · patent.txt lines 5,307, 5,320, 5,333, 5,346, 5,359
- Latest exclusivity
- 9 May 2028M-315 exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006 · exclusivity.txt lines 452, 457, 462, 467, 472, 477
36 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 205422, as listed. The sections below name products by these numbers.
Product 001 · REXULTI
- Dosage form; route
- TABLET;ORAL
- Strength
- 0.25MG
- Approval date as listed
- 10 Jul 2015
- Type as listed
- RX
- Applicant as listed
- OTSUKA PHARMACEUTICAL CO LTD
Product 002 · REXULTI
- Dosage form; route
- TABLET;ORAL
- Strength
- 0.5MG
- Approval date as listed
- 10 Jul 2015
- Type as listed
- RX
- Applicant as listed
- OTSUKA PHARMACEUTICAL CO LTD
Product 003 · REXULTI
- Dosage form; route
- TABLET;ORAL
- Strength
- 1MG
- Approval date as listed
- 10 Jul 2015
- Type as listed
- RX
- Applicant as listed
- OTSUKA PHARMACEUTICAL CO LTD
Product 004 · REXULTI
- Dosage form; route
- TABLET;ORAL
- Strength
- 2MG
- Approval date as listed
- 10 Jul 2015
- Type as listed
- RX
- Applicant as listed
- OTSUKA PHARMACEUTICAL CO LTD
Product 005 · REXULTI
- Dosage form; route
- TABLET;ORAL
- Strength
- 3MG
- Approval date as listed
- 10 Jul 2015
- Type as listed
- RX
- Applicant as listed
- OTSUKA PHARMACEUTICAL CO LTD
Product 006 · REXULTI
- Dosage form; route
- TABLET;ORAL
- Strength
- 4MG
- Approval date as listed
- 10 Jul 2015
- Type as listed
- RX
- Applicant as listed
- OTSUKA PHARMACEUTICAL CO LTD
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.
13 entries from 76 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,349,840, product and use patent
patent.txt lines 5,310, 5,323, 5,336, 5,349, 5,362, 5,373- Expiry as listed
- 12 Apr 2026
- Rule
- R1
- Flags
- product · use code U-1529
- Product numbers
- 001, 002, 003, 004, 005, 006
US 8,618,109, use patent
patent.txt lines 5,312, 5,325, 5,338, 5,351, 5,364, 5,375- Expiry as listed
- 12 Apr 2026
- Rule
- R1
- Flags
- use code U-3281
- Product numbers
- 001, 002, 003, 004, 005, 006
US 8,618,109, use patent
patent.txt lines 5,313, 5,326, 5,339, 5,352, 5,365, 5,376- Expiry as listed
- 12 Apr 2026
- Rule
- R1
- Flags
- use code U-543
- Product numbers
- 001, 002, 003, 004, 005, 006
US 9,839,637, product and use patent
patent.txt lines 5,315, 5,328, 5,341, 5,354, 5,367, 5,378- Expiry as listed
- 12 Apr 2026
- Rule
- R1
- Flags
- product · use code U-1529
- Product numbers
- 001, 002, 003, 004, 005, 006
US 9,839,637, product and use patent
patent.txt lines 5,316, 5,329, 5,342, 5,355, 5,368, 5,379- Expiry as listed
- 12 Apr 2026
- Rule
- R1
- Flags
- product · use code U-3281
- Product numbers
- 001, 002, 003, 004, 005, 006
US 9,839,637, product and use patent
patent.txt lines 5,317, 5,330, 5,343, 5,356, 5,369, 5,380- Expiry as listed
- 12 Apr 2026
- Rule
- R1
- Flags
- product · use code U-543
- Product numbers
- 001, 002, 003, 004, 005, 006
US 8,349,840 with pediatric exclusivity, as listed
patent.txt lines 5,309, 5,322, 5,335, 5,348, 5,361, 5,372- Expiry as listed
- 12 Oct 2026
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
US 8,618,109 with pediatric exclusivity, as listed
patent.txt lines 5,311, 5,324, 5,337, 5,350, 5,363, 5,374- Expiry as listed
- 12 Oct 2026
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
US 9,839,637 with pediatric exclusivity, as listed
patent.txt lines 5,314, 5,327, 5,340, 5,353, 5,366, 5,377- Expiry as listed
- 12 Oct 2026
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
US RE48059, substance patent
patent.txt lines 5,319, 5,332, 5,345, 5,358, 5,371, 5,382- Expiry as listed
- 23 Dec 2028
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002, 003, 004, 005, 006
US RE48059 with pediatric exclusivity, as listed
patent.txt lines 5,318, 5,331, 5,344, 5,357, 5,370, 5,381- Expiry as listed
- 23 Jun 2029
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
US 10,307,419, product patent
patent.txt lines 5,308, 5,321, 5,334, 5,347, 5,360- Expiry as listed
- 12 Oct 2032
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
US 10,307,419 with pediatric exclusivity, as listed
patent.txt lines 5,307, 5,320, 5,333, 5,346, 5,359- Expiry as listed
- 12 Apr 2033
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
Listed exclusivities
Each exclusivity FDA lists for NDA 205422, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
I-913 exclusivity
exclusivity.txt lines 450, 455, 460, 465, 470, 475- Date
- 10 May 2026
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
PED exclusivity
exclusivity.txt lines 453, 458, 463, 468, 473, 478- Date
- 10 Nov 2026
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
M-14 exclusivity
exclusivity.txt lines 451, 456, 461, 466, 471, 476- Date
- 8 May 2027
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
PED exclusivity
exclusivity.txt lines 454, 459, 464, 469, 474, 479- Date
- 8 Nov 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
M-315 exclusivity
exclusivity.txt lines 452, 457, 462, 467, 472, 477- Date
- 9 May 2028
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
Paragraph IV list rows giving NDA 205422
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 205422, 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 205422
Brexpiprazole · Tablets · 0.25 mg
RLD/NDA as listed: Rexulti 205422- First PIV submission
- 10 Jul 2019
- ANDAs
- 17
- 180-day status
- Eligible
- Decision posted
- 6 Sep 2022
- First applicant approval
- 11 Aug 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Oct 2032
Brexpiprazole · Tablets · 0.5 mg, 1 mg, 2 mg and 3 mg
RLD/NDA as listed: Rexulti 205422- First PIV submission
- 10 Jul 2019
- ANDAs
- 18
- 180-day status
- Eligible
- Decision posted
- 6 Sep 2022
- First applicant approval
- 11 Aug 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Oct 2032
Brexpiprazole · Tablets · 4 mg
RLD/NDA as listed: Rexulti 205422- First PIV submission
- 10 Jul 2019
- ANDAs
- 16
- 180-day status
- Extinguished Eligible
- Decision posted
- 4/13/2026 9/6/2022
- First applicant approval
- 11 Aug 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Apr 2026
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