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WAKIX

NDA

PITOLISANT HYDROCHLORIDE | N211150 | HARMONY BIOSCIENCES MANAGEMENT INC

2 strengths3 unique patents5 unique exclusivities

Patent Timeline

3 unique patents, 5 exclusivities by expiration date

Expired (1)Active (2)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

Today

8207197

Mar. 7, 2030

8354430

Feb. 6, 2026

8486947

Sep. 26, 2029

ODE-255

Aug. 14, 2026

NPP

Jun. 21, 2027

ODE-331

Oct. 13, 2027

ODE-489

Jun. 21, 2031

ODE-519

Feb. 13, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

90/019,228Ex ParteDenied

Patent: 8207197Filed: 2023-07-19

MONOHYDROCHLORIDE SALT OF 1-[3-[3-(4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE

Recent Events

2024-07-31MRPTDPetition Decision Denying Reexamination

2023-08-24MREXDReexam Request Denied

2023-07-25RXLITSRLitigation Search Conducted

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

Hatch-Waxman Litigation

6 cases on OB patents (3 active) from PACER

Case	Court	Filed	Status	Judge
Harmony Biosciences Management, Inc. et al v. Lupin Limited et al 1:2025cv00102 2 patentsANDA 218846pitolisant hydrochloride	D. Del.	2025-01-24	Terminated 2025-06-11	—
Harmony Biosciences, LLC et al v. AET Pharma US, Inc. et al 1:2024cv00941 2 patentsANDA 218892pitolisant hydrochloride	D. Del.	2024-08-13	Active	—
Harmony Biosciences, LLC et al v. MSN Pharmaceuticals Inc. et al 1:2023cv01420 3 patentsANDA 218873pitolisant hydrochloride	D. Del.	2023-12-11	Terminated 2026-01-21	—
MSN Laboratories Private Limited v. Bioprojet Societe Civile De Recherche 1:2023cv01675 3 patentsANDA 218873pitolisant hydrochloride	E.D. Va.	2023-12-08	Terminated 2024-01-12	—
Harmony Biosciences, LLC et al v. AET Pharma US, Inc. et al 1:2023cv01340	D. Del.	2023-11-21	Active	—
Harmony Biosciences, LLC et al v. Lupin Limited et al 1:2023cv01286 2 patentsANDA 218846, 218834pitolisant hydrochloride	D. Del.	2023-11-09	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pugsley Wood, LLP (on behalf of Scorpion Capital, LLC) FDA-2023-P-1273 · 5 docket documents Scorpion Capital LLC filed this citizen petition on April 3, 2023, requesting that the FDA withdraw approval of Wakix (pitolisant), an NDA-approved drug marketed by Harmony Biosciences for excessive daytime sleepiness and cataplexy in narcolepsy patients. The petitioner alleges grave safety concerns	505(q)	2023-04-04	Denied	Scorpion Capital, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

8 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA NCT02739568	Phase 3	Completed	Bioprojet	389	2016-04 → 2020-04
Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.NCT01638403	Phase 3	Completed	Bioprojet	180	2010-11 → 2012-07
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)NCT01789398	Phase 3	Completed	Bioprojet	51	2012-09 → 2014-08
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy NCT01067235	Phase 3	Completed	Bioprojet	14	2009-10 → 2010-07
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy NCT01067222	Phase 3	Completed	Bioprojet	110	2009-05 → 2010-12
Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users NCT03152123	Phase 1	Completed	Bioprojet	43	2017-03-15 → 2017-10-23
A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment NCT02800083	Phase 2	Withdrawn	Bioprojet	—	2016-10
Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness NCT02978651	Phase 3	Withdrawn	Bioprojet	—	—

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$2684.73

Highest Price

$5365.86

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72028-0045-03WAKIX 4.45MG TAB	$2684.73	FSS	Harmony Biosciences, LLC	06/14/2026
72028-0178-03WAKIX 17.8MG TAB	$5365.86	FSS	Harmony Biosciences, LLC	06/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Wakix (2024)

Total Spending

$132.5M

Total Claims

10,596

Beneficiaries

1,402

Avg Cost/Unit

$248.34

Spending Trend

$1.2M(2019)→$31.5M(2020)→$55.8M(2021)→$65.6M(2022)→$101.4M(2023)→$132.5M(2024)

YoY Change:+5.1%

5yr CAGR:+7.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

NURAY CHEMICALS PVT LTDPITOLISANT HYDROCHLORIDE

DMF 368592022

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPITOLISANT HYDROCHLORIDE SOLID DISPERSION

DMF 377532022

MSN LABORATORIES PRIVATE LTDPITOLISANT

DMF 381312023

NURAY CHEMICALS PRIVATE LTDPITOLISANT HYDROCHLORIDE SD

DMF 381742023

DASAMI LAB PRIVATE LTDPITOLISANT HYDROCHLORIDE

DMF 383072023

EMNAR PHARMA PRIVATE LTDPITOLISANT HYDROCHLORIDE

DMF 391262023

NEW HORIZON PHARMA US INCPITOLISANT HYDROCHLORIDE IN-HOUSE

DMF 397212024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 18, 2026	SUPPL -6	View Letter (PDF)
May 28, 2025	SUPPL -7	View Letter (PDF)
Sep 3, 2024	SUPPL -5	View Letter (PDF)
Dec 23, 2022	SUPPL -3	View Letter (PDF)
Nov 3, 2020	ORIG -2	View Letter (PDF)
Aug 16, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 4.45MG BASE

RLD

3 patents5 exclusivities▴

TABLET;ORAL | Approved: Aug 14, 2019

Patents (3) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8207197	Mar 7, 2030	—	Yes	Yes	—	—
8354430	Feb 6, 2026	—	—	—		—
8486947	Sep 26, 2029	—	—	—		—

Exclusivities (5)

Code	Date	Status
NPP	Jun 21, 2027	< 1 year
ODE-255	Aug 14, 2026	< 1 year
ODE-331	Oct 13, 2027	Active
ODE-489	Jun 21, 2031	Active
ODE-519	Feb 13, 2033	Active

#002 — EQ 17.8MG BASE

RLD

3 patents5 exclusivities▾

TABLET;ORAL | Approved: Aug 14, 2019