Drybench Patent.
DEXMEDETOMIDINE HYDROCHLORIDE, NDA 215390
The patents and exclusivities FDA's Orange Book lists for NDA 215390 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. 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 appDEXMEDETOMIDINE HYDROCHLORIDE in the molecule app
Listed protection
Listed dates run from 19 Nov 2028 to 12 Jan 2043, each by its own rule; no one date stands for this product.
- Earliest listed date
- 19 Nov 2028M-82 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 1,559–1,560
- Latest listed date
- 12 Jan 2043US 12,364,683, use patentRule R1 · Products 001, 002
Source lines
patent.txt lines 16,842, 16,857
- Latest substance patent
- None listed
- Latest listed patent
- 12 Jan 2043US 12,364,683, use patentRule R1 · Products 001, 002
Source lines
patent.txt lines 16,842, 16,857
- Latest exclusivity
- 19 Nov 2028M-82 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 1,559–1,560
Listed dates of other NDAs in the same years:20282037203920402043
28 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 215390, as listed. The sections below name products by these numbers.
Product 001 · IGALMI
- Dosage form; route
- FILM;
BUCCAL, SUBLINGUAL - Strength
- EQ 0.12MG BASE
- Approval date as listed
- 5 Apr 2022
- Type as listed
- RX
- Applicant as listed
- BIOXCEL THERAPEUTICS INC
Product 002 · IGALMI
- Dosage form; route
- FILM;
BUCCAL, SUBLINGUAL - Strength
- EQ 0.18MG BASE
- Approval date as listed
- 5 Apr 2022
- Type as listed
- RX
- Applicant as listed
- BIOXCEL THERAPEUTICS 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.
15 entries from 30 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 11,786,508, use patent
patent.txt lines 16,832, 16,847- Expiry as listed
- 29 Dec 2037
- Rule
- R1
- Flags
- use code U-3698
- Product numbers
- 001, 002
US 11,839,604, use patent
patent.txt lines 16,834, 16,849- Expiry as listed
- 29 Dec 2037
- Rule
- R1
- Flags
- use code U-3756
- Product numbers
- 001, 002
US 10,792,246, product and use patent
patent.txt lines 16,828, 16,843- Expiry as listed
- 26 Jun 2039
- Rule
- R1
- Flags
- product · use code U-3350
- Product numbers
- 001, 002
US 11,478,422, product patent
patent.txt lines 16,829, 16,844- Expiry as listed
- 26 Jun 2039
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 11,497,711, product and use patent
patent.txt lines 16,830, 16,845- Expiry as listed
- 26 Jun 2039
- Rule
- R1
- Flags
- product · use code U-3645
- Product numbers
- 001, 002
US 11,517,524, product and use patent
patent.txt lines 16,831, 16,846- Expiry as listed
- 26 Jun 2039
- Rule
- R1
- Flags
- product · use code U-3645
- Product numbers
- 001, 002
US 11,890,272, use patent
patent.txt lines 16,835, 16,850- Expiry as listed
- 17 Jul 2040
- Rule
- R1
- Flags
- use code U-3756
- Product numbers
- 001, 002
US 11,890,272, use patent
patent.txt lines 16,836, 16,851- Expiry as listed
- 17 Jul 2040
- Rule
- R1
- Flags
- use code U-3935
- Product numbers
- 001, 002
US 11,998,529, use patent
patent.txt lines 16,838, 16,853- Expiry as listed
- 17 Jul 2040
- Rule
- R1
- Flags
- use code U-3935
- Product numbers
- 001, 002
US 12,109,196, use patent
patent.txt lines 16,840, 16,855- Expiry as listed
- 17 Jul 2040
- Rule
- R1
- Flags
- use code U-3935
- Product numbers
- 001, 002
US 11,806,334, use patent
patent.txt lines 16,833, 16,848- Expiry as listed
- 12 Jan 2043
- Rule
- R1
- Flags
- use code U-3725
- Product numbers
- 001, 002
US 11,998,528, use patent
patent.txt lines 16,837, 16,852- Expiry as listed
- 12 Jan 2043
- Rule
- R1
- Flags
- use code U-3935
- Product numbers
- 001, 002
US 12,090,140, use patent
patent.txt lines 16,839, 16,854- Expiry as listed
- 12 Jan 2043
- Rule
- R1
- Flags
- use code U-3986
- Product numbers
- 001, 002
US 12,138,247, use patent
patent.txt lines 16,841, 16,856- Expiry as listed
- 12 Jan 2043
- Rule
- R1
- Flags
- use code U-4029
- Product numbers
- 001, 002
US 12,364,683, use patent
patent.txt lines 16,842, 16,857- Expiry as listed
- 12 Jan 2043
- Rule
- R1
- Flags
- use code U-4029
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 215390, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
M-82 exclusivity
exclusivity.txt lines 1,559–1,560- Date
- 19 Nov 2028
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 215390
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 215390, each cell as listed.
Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.
No row of the Paragraph IV list captured on 17 October 2026 gives NDA 215390 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.
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