Drybench Patent.
PITOLISANT HYDROCHLORIDE, NDA 211150
The patents and exclusivities FDA's Orange Book lists for NDA 211150 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 6 Feb 2026 to 13 Feb 2033, each by its own rule; no one date stands for this product.
- Earliest listed date
- 6 Feb 2026US 8,354,430, use patentRule R1 · Products 001, 002 · patent.txt lines 12,481, 12,486
- Latest listed date
- 13 Feb 2033ODE-519 exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 936, 941
- Latest substance patent
- 7 Mar 2030US 8,207,197, substance and product patentRule R1 · Products 001, 002 · patent.txt lines 12,480, 12,485
- Latest listed patent
- 7 Mar 2030US 8,207,197, substance and product patentRule R1 · Products 001, 002 · patent.txt lines 12,480, 12,485
- Latest exclusivity
- 13 Feb 2033ODE-519 exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 936, 941
8 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 211150, as listed. The sections below name products by these numbers.
Product 001 · WAKIX
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 4.45MG BASE
- Approval date as listed
- 14 Aug 2019
- Type as listed
- RX
- Applicant as listed
- HARMONY BIOSCIENCES MANAGEMENT INC
Product 002 · WAKIX
- Dosage form; route
- TABLET;ORAL
- Strength
- EQ 17.8MG BASE
- Approval date as listed
- 14 Aug 2019
- Type as listed
- RX
- Applicant as listed
- HARMONY BIOSCIENCES MANAGEMENT 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.
5 entries from 10 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,354,430, use patent
patent.txt lines 12,481, 12,486- Expiry as listed
- 6 Feb 2026
- Rule
- R1
- Flags
- use code U-1101
- Product numbers
- 001, 002
US 8,354,430, use patent
patent.txt lines 12,482, 12,487- Expiry as listed
- 6 Feb 2026
- Rule
- R1
- Flags
- use code U-1102
- Product numbers
- 001, 002
US 8,486,947, use patent
patent.txt lines 12,483, 12,488- Expiry as listed
- 26 Sep 2029
- Rule
- R1
- Flags
- use code U-1101
- Product numbers
- 001, 002
US 8,486,947, use patent
patent.txt lines 12,484, 12,489- Expiry as listed
- 26 Sep 2029
- Rule
- R1
- Flags
- use code U-1102
- Product numbers
- 001, 002
US 8,207,197, substance and product patent
patent.txt lines 12,480, 12,485- Expiry as listed
- 7 Mar 2030
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 211150, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-255 exclusivity
exclusivity.txt lines 933, 938- Date
- 14 Aug 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
NPP exclusivity
exclusivity.txt lines 932, 937- Date
- 21 Jun 2027
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-331 exclusivity
exclusivity.txt lines 934, 939- Date
- 13 Oct 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-489 exclusivity
exclusivity.txt lines 935, 940- Date
- 21 Jun 2031
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-519 exclusivity
exclusivity.txt lines 936, 941- Date
- 13 Feb 2033
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 211150
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 211150, 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 211150
Pitolisant Hydrochloride · Tablets · 4.45 mg and 17.8 mg
RLD/NDA as listed: Wakix 211150- First PIV submission
- 14 Aug 2023
- ANDAs
- 7
- 180-day status
- Eligible
- Decision posted
- 3 Aug 2026
- First applicant approval
- 21 Jul 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 7 Mar 2030
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