Drybench Patent.
LUMATEPERONE TOSYLATE, NDA 209500
The patents and exclusivities FDA's Orange Book lists for NDA 209500 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 Mar 2028 to 10 Dec 2040, each by its own rule; no one date stands for this product.
- Earliest listed date
- 12 Mar 2028US 10,464,938, product patentRule R1 · Products 001, 002, 003 · patent.txt lines 10,435, 10,471, 10,502
- Latest listed date
- 10 Dec 2040US 12,410,195, product patentRule R1 · Products 001, 002, 003 · patent.txt lines 10,458, 10,490, 10,521
- Latest substance patent
- 1 Dec 2029US 8,648,077, substance and product patentRule R1 · Products 001, 002, 003 · patent.txt lines 10,460, 10,491, 10,522
- Latest listed patent
- 10 Dec 2040US 12,410,195, product patentRule R1 · Products 001, 002, 003 · patent.txt lines 10,458, 10,490, 10,521
- Latest exclusivity
- 24 Apr 2029M-319 exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 789, 791, 793
4 patents with a delist request, kept in the table · 77 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 209500, as listed. The sections below name products by these numbers.
Product 001 · CAPLYTA
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 42MG BASE
- Approval date as listed
- 20 Dec 2019
- Type as listed
- RX
- Applicant as listed
- INTRA-CELLULAR THERAPIES INC
Product 002 · CAPLYTA
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 10.5MG BASE
- Approval date as listed
- 22 Apr 2022
- Type as listed
- RX
- Applicant as listed
- INTRA-CELLULAR THERAPIES INC
Product 003 · CAPLYTA
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 21MG BASE
- Approval date as listed
- 22 Apr 2022
- Type as listed
- RX
- Applicant as listed
- INTRA-CELLULAR THERAPIES 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.
43 entries from 97 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 10,464,938, product patent
patent.txt lines 10,435, 10,471, 10,502- Expiry as listed
- 12 Mar 2028
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 9,199,995, use patent
patent.txt lines 10,461, 10,493, 10,523- Expiry as listed
- 12 Mar 2029
- Rule
- R1
- Flags
- use code U-2713
- Product numbers
- 001, 002, 003
US 9,199,995, use patent
patent.txt lines 10,462, 10,494, 10,524- Expiry as listed
- 12 Mar 2029
- Rule
- R1
- Flags
- use code U-4343
- Product numbers
- 001, 002, 003
US 9,586,960, substance and product patent
patent.txt line 10,463- Expiry as listed
- 12 Mar 2029
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US RE48825, substance and product patent
patent.txt line 10,466- Expiry as listed
- 12 Mar 2029
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US RE48825, substance patent
patent.txt lines 10,497, 10,527- Expiry as listed
- 12 Mar 2029
- Rule
- R1
- Flags
- substance
- Product numbers
- 002, 003
US 10,117,867, use patent
patent.txt lines 10,434, 10,470, 10,501- Expiry as listed
- 27 May 2029
- Rule
- R1
- Flags
- use code U-3271
- Product numbers
- 001, 002, 003
US 9,168,258, product patent
patent.txt line 10,492- Expiry as listed
- 27 May 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 002
US 9,616,061, product patent
patent.txt lines 10,464, 10,495, 10,525- Expiry as listed
- 27 May 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
US 8,648,077, substance and product patent
patent.txt lines 10,460, 10,491, 10,522- Expiry as listed
- 1 Dec 2029
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003
US 8,598,119, use patent
patent.txt line 10,459- Expiry as listed
- 28 Dec 2029
- Rule
- R1
- Flags
- use code U-543 · delist requested
- Product numbers
- 001
US RE48839, use patent
patent.txt lines 10,467, 10,498, 10,528- Expiry as listed
- 19 Aug 2033
- Rule
- R1
- Flags
- use code U-3271
- Product numbers
- 001, 002, 003
US RE48839, use patent
patent.txt lines 10,468, 10,499, 10,529- Expiry as listed
- 19 Aug 2033
- Rule
- R1
- Flags
- use code U-4344
- Product numbers
- 001, 002, 003
US RE48839, use patent
patent.txt lines 10,469, 10,500, 10,530- Expiry as listed
- 19 Aug 2033
- Rule
- R1
- Flags
- use code U-814
- Product numbers
- 001, 002, 003
US 10,960,009, use patent
patent.txt line 10,437- Expiry as listed
- 3 Dec 2034
- Rule
- R1
- Flags
- use code U-814
- Product numbers
- 001
US 11,026,951, use patent
patent.txt line 10,438- Expiry as listed
- 3 Dec 2034
- Rule
- R1
- Flags
- use code U-3274
- Product numbers
- 001
US 11,026,951, use patent
patent.txt lines 10,473, 10,504- Expiry as listed
- 3 Dec 2034
- Rule
- R1
- Flags
- use code U-3364
- Product numbers
- 002, 003
US 9,956,227, use patent
patent.txt lines 10,465, 10,496, 10,526- Expiry as listed
- 3 Dec 2034
- Rule
- R1
- Flags
- use code U-2714
- Product numbers
- 001, 002, 003
US 12,409,176, use patent
patent.txt lines 10,457, 10,489, 10,520- Expiry as listed
- 15 Mar 2039
- Rule
- R1
- Flags
- use code U-4261
- Product numbers
- 001, 002, 003
US 10,695,345, product and use patent
patent.txt line 10,436- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-543
- Product numbers
- 001
US 10,695,345, product and use patent
patent.txt lines 10,472, 10,503- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-814
- Product numbers
- 002, 003
US 11,052,084, product and use patent
patent.txt lines 10,474, 10,505- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3362
- Product numbers
- 002, 003
US 11,052,084, product and use patent
patent.txt lines 10,475, 10,506- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3363
- Product numbers
- 002, 003
US 11,052,084, product and use patent
patent.txt lines 10,476, 10,507- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-4341
- Product numbers
- 002, 003
US 11,690,842, product and use patent
patent.txt lines 10,439, 10,477, 10,508- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3362
- Product numbers
- 001, 002, 003
US 11,690,842, product and use patent
patent.txt lines 10,440, 10,478, 10,509- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3363
- Product numbers
- 001, 002, 003
US 11,690,842, product and use patent
patent.txt lines 10,441, 10,479, 10,510- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-4341
- Product numbers
- 001, 002, 003
US 11,806,348, product and use patent
patent.txt lines 10,443, 10,481, 10,512- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3362
- Product numbers
- 001, 002, 003
US 11,806,348, product and use patent
patent.txt lines 10,444, 10,482, 10,513- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3363
- Product numbers
- 001, 002, 003
US 11,806,348, product and use patent
patent.txt lines 10,445, 10,483, 10,514- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-4341
- Product numbers
- 001, 002, 003
US 12,070,459, product and use patent
patent.txt line 10,448- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3362
- Product numbers
- 001
US 12,070,459, product and use patent
patent.txt line 10,449- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3363
- Product numbers
- 001
US 12,070,459, product and use patent
patent.txt line 10,450- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-4341
- Product numbers
- 001
US 12,128,043, product and use patent
patent.txt line 10,455- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3362
- Product numbers
- 001
US 12,128,043, product and use patent
patent.txt line 10,456- Expiry as listed
- 30 Aug 2039
- Rule
- R1
- Flags
- product · use code U-3363
- Product numbers
- 001
US 11,980,617, use patent
patent.txt lines 10,446, 10,484, 10,515- Expiry as listed
- 27 Oct 2039
- Rule
- R1
- Flags
- use code U-3940
- Product numbers
- 001, 002, 003
US 11,980,617, use patent
patent.txt lines 10,447, 10,485, 10,516- Expiry as listed
- 27 Oct 2039
- Rule
- R1
- Flags
- use code U-4342
- Product numbers
- 001, 002, 003
US 12,090,155, product and use patent
patent.txt line 10,451- Expiry as listed
- 7 Jul 2040
- Rule
- R1
- Flags
- product · use code U-4000
- Product numbers
- 001
US 11,753,419, product patent
patent.txt lines 10,442, 10,480, 10,511- Expiry as listed
- 10 Dec 2040
- Rule
- R1
- Flags
- product · delist requested
- Product numbers
- 001, 002, 003
US 12,122,792, product and use patent
patent.txt lines 10,452, 10,486, 10,517- Expiry as listed
- 10 Dec 2040
- Rule
- R1
- Flags
- product · use code U-4019
- Product numbers
- 001, 002, 003
US 12,122,792, product and use patent
patent.txt lines 10,453, 10,487, 10,518- Expiry as listed
- 10 Dec 2040
- Rule
- R1
- Flags
- product · use code U-4020
- Product numbers
- 001, 002, 003
US 12,122,792, product and use patent
patent.txt lines 10,454, 10,488, 10,519- Expiry as listed
- 10 Dec 2040
- Rule
- R1
- Flags
- product · use code U-4340
- Product numbers
- 001, 002, 003
US 12,410,195, product patent
patent.txt lines 10,458, 10,490, 10,521- Expiry as listed
- 10 Dec 2040
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003
Listed exclusivities
Each exclusivity FDA lists for NDA 209500, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
I-904 exclusivity
exclusivity.txt lines 788, 790, 792- Date
- 5 Nov 2028
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
M-319 exclusivity
exclusivity.txt lines 789, 791, 793- Date
- 24 Apr 2029
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
Paragraph IV list rows giving NDA 209500
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 209500, 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 209500
Lumateperone Tosylate · Capsules · 10.5 mg and 21 mg
RLD/NDA as listed: Caplyta 209500- First PIV submission
- 20 Dec 2023
- ANDAs
- 6
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Dec 2040
Lumateperone Tosylate · Capsules · 42 mg
RLD/NDA as listed: Caplyta 209500- First PIV submission
- 20 Dec 2023
- ANDAs
- 7
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Dec 2040
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