Drybench Patent.
CARIPRAZINE HYDROCHLORIDE, NDA 204370
The patents and exclusivities FDA's Orange Book lists for NDA 204370 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 appCARIPRAZINE HYDROCHLORIDE in the molecule app
Listed protection
Listed dates run from 16 Dec 2028 to 17 Mar 2030, each by its own rule; no one date stands for this product.
- Earliest listed date
- 16 Dec 2028US 7,943,621, substance and product patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 4,557, 4,581, 4,597, 4,612
- Latest listed date
- 17 Mar 2030US 7,737,142 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005, 006 · patent.txt lines 4,550, 4,574, 4,592, 4,607, 4,622, 4,639
- Latest substance patent
- 17 Mar 2030US 7,737,142 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005, 006 · patent.txt lines 4,550, 4,574, 4,592, 4,607, 4,622, 4,639
- Latest listed patent
- 17 Mar 2030US 7,737,142 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004, 005, 006 · patent.txt lines 4,550, 4,574, 4,592, 4,607, 4,622, 4,639
- Latest exclusivity
- 18 Jun 2029PED exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006 · exclusivity.txt lines 398–399, 402–403, 406–407, 409, 412–413, 416–417
75 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 204370, as listed. The sections below name products by these numbers.
Product 001 · VRAYLAR
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 1.5MG BASE
- Approval date as listed
- 17 Sep 2015
- Type as listed
- RX
- Applicant as listed
- ABBVIE INC
Product 002 · VRAYLAR
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 3MG BASE
- Approval date as listed
- 17 Sep 2015
- Type as listed
- RX
- Applicant as listed
- ABBVIE INC
Product 003 · VRAYLAR
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 4.5MG BASE
- Approval date as listed
- 17 Sep 2015
- Type as listed
- RX
- Applicant as listed
- ABBVIE INC
Product 004 · VRAYLAR
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 6MG BASE
- Approval date as listed
- 17 Sep 2015
- Type as listed
- RX
- Applicant as listed
- ABBVIE INC
Product 005 · VRAYLAR
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 0.5MG BASE
- Approval date as listed
- 18 Dec 2025
- Type as listed
- RX
- Applicant as listed
- ABBVIE INC
Product 006 · VRAYLAR
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 0.75MG BASE
- Approval date as listed
- 18 Dec 2025
- Type as listed
- RX
- Applicant as listed
- ABBVIE 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.
26 entries from 106 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,943,621, substance and product patent
patent.txt lines 4,557, 4,581, 4,597, 4,612- Expiry as listed
- 16 Dec 2028
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 7,943,621, substance and product patent
patent.txt lines 4,628, 4,645- Expiry as listed
- 20 Dec 2028
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 005, 006
US 7,943,621 with pediatric exclusivity, as listed
patent.txt lines 4,556, 4,580, 4,596, 4,611- Expiry as listed
- 16 Jun 2029
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 7,943,621 with pediatric exclusivity, as listed
patent.txt lines 4,627, 4,644- Expiry as listed
- 20 Jun 2029
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 005, 006
US RE47350, use patent
patent.txt line 4,559- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-1750
- Product numbers
- 001
US RE47350, use patent
patent.txt lines 4,560, 4,630, 4,647- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2543
- Product numbers
- 001, 005, 006
US RE47350, use patent
patent.txt lines 4,561, 4,631, 4,648- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2544
- Product numbers
- 001, 005, 006
US RE47350, use patent
patent.txt lines 4,562, 4,632, 4,649- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2545
- Product numbers
- 001, 005, 006
US RE47350, use patent
patent.txt lines 4,563, 4,633, 4,650- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-3503
- Product numbers
- 001, 005, 006
US RE49110, use patent
patent.txt lines 4,565, 4,583, 4,599, 4,614, 4,635, 4,652- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2543
- Product numbers
- 001, 002, 003, 004, 005, 006
US RE49110, use patent
patent.txt lines 4,566, 4,584, 4,600, 4,615, 4,636, 4,653- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2544
- Product numbers
- 001, 002, 003, 004, 005, 006
US RE49110, use patent
patent.txt lines 4,567, 4,585, 4,601, 4,616, 4,637, 4,654- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2545
- Product numbers
- 001, 002, 003, 004, 005, 006
US RE49110, use patent
patent.txt lines 4,568, 4,586, 4,638, 4,655- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-3503
- Product numbers
- 001, 002, 005, 006
US RE49302, use patent
patent.txt lines 4,570, 4,588, 4,603, 4,618- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2543
- Product numbers
- 001, 002, 003, 004
US RE49302, use patent
patent.txt lines 4,571, 4,589, 4,604, 4,619- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2544
- Product numbers
- 001, 002, 003, 004
US RE49302, use patent
patent.txt lines 4,572, 4,590, 4,605, 4,620- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-2545
- Product numbers
- 001, 002, 003, 004
US RE49302, use patent
patent.txt lines 4,573, 4,591, 4,606, 4,621- Expiry as listed
- 16 Jul 2029
- Rule
- R1
- Flags
- use code U-3503
- Product numbers
- 001, 002, 003, 004
US 7,737,142, substance and product and use patent
patent.txt lines 4,551, 4,575, 4,593, 4,608- Expiry as listed
- 17 Sep 2029
- Rule
- R1
- Flags
- substance · product · use code U-1750
- Product numbers
- 001, 002, 003, 004
US 7,737,142, substance and product and use patent
patent.txt lines 4,552, 4,576, 4,594, 4,609, 4,623, 4,640- Expiry as listed
- 17 Sep 2029
- Rule
- R1
- Flags
- substance · product · use code U-2543
- Product numbers
- 001, 002, 003, 004, 005, 006
US 7,737,142, substance and product and use patent
patent.txt lines 4,553, 4,577, 4,595, 4,610, 4,624, 4,641- Expiry as listed
- 17 Sep 2029
- Rule
- R1
- Flags
- substance · product · use code U-2544
- Product numbers
- 001, 002, 003, 004, 005, 006
US 7,737,142, substance and product and use patent
patent.txt lines 4,554, 4,578, 4,625, 4,642- Expiry as listed
- 17 Sep 2029
- Rule
- R1
- Flags
- substance · product · use code U-2545
- Product numbers
- 001, 002, 005, 006
US 7,737,142, substance and product and use patent
patent.txt lines 4,555, 4,579, 4,626, 4,643- Expiry as listed
- 17 Sep 2029
- Rule
- R1
- Flags
- substance · product · use code U-3503
- Product numbers
- 001, 002, 005, 006
US RE47350 with pediatric exclusivity, as listed
patent.txt lines 4,558, 4,629, 4,646- Expiry as listed
- 16 Jan 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 005, 006
US RE49110 with pediatric exclusivity, as listed
patent.txt lines 4,564, 4,582, 4,598, 4,613, 4,634, 4,651- Expiry as listed
- 16 Jan 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
US RE49302 with pediatric exclusivity, as listed
patent.txt lines 4,569, 4,587, 4,602, 4,617- Expiry as listed
- 16 Jan 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 7,737,142 with pediatric exclusivity, as listed
patent.txt lines 4,550, 4,574, 4,592, 4,607, 4,622, 4,639- Expiry as listed
- 17 Mar 2030
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
Listed exclusivities
Each exclusivity FDA lists for NDA 204370, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
M-14 exclusivity
exclusivity.txt lines 396, 400, 404, 408, 410, 414- Date
- 18 Dec 2028
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
NPP exclusivity
exclusivity.txt lines 397, 401, 405, 411, 415- Date
- 18 Dec 2028
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 005, 006
PED exclusivity
exclusivity.txt lines 398–399, 402–403, 406–407, 409, 412–413, 416–417- Date
- 18 Jun 2029
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
Paragraph IV list rows giving NDA 204370
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 204370, 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 204370
Cariprazine · Capsules · 1.5 mg, 3 mg, 4.5 mg and 6 mg
RLD/NDA as listed: Vraylar 204370- First PIV submission
- 17 Sep 2019
- ANDAs
- 3
- 180-day status
- Eligible
- Decision posted
- 4 Oct 2022
- First applicant approval
- 9 Sep 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 16 Jul 2029
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