Pitolisant hydrochloride - Generic Drug Details

What are the generic drug sources for pitolisant hydrochloride and what is the scope of freedom to operate?

Pitolisant hydrochloride is the generic ingredient in one branded drug marketed by Harmony and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pitolisant hydrochloride has sixty-one patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for pitolisant hydrochloride

International Patents:	61
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	32
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pitolisant hydrochloride
What excipients (inactive ingredients) are in pitolisant hydrochloride?	pitolisant hydrochloride excipients list
DailyMed Link:	pitolisant hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for pitolisant hydrochloride

Constraining patent/regulatory exclusivity:

TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH NARCOLEPSY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for pitolisant hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Harmony Biosciences Management, Inc.	PHASE1
Harmony Biosciences Management, Inc.	PHASE3
Bioprojet	PHASE2

See all pitolisant hydrochloride clinical trials

Pharmacology for pitolisant hydrochloride

Drug Class	Histamine-3 Receptor Antagonist/Inverse Agonist
Mechanism of Action	Cytochrome P450 3A4 Inducers Histamine H3 Receptor Antagonists Histamine H3 Receptor Inverse Agonists

Anatomical Therapeutic Chemical (ATC) Classes for pitolisant hydrochloride

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for PITOLISANT HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WAKIX	Tablets	pitolisant hydrochloride	4.45 mg and 17.8 mg	211150	7	2023-08-14

US Patents and Regulatory Information for pitolisant hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019		RX	Yes	Yes	8,354,430
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019		RX	Yes	Yes
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No

Expired US Patents for pitolisant hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019	7,169,928
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019	7,169,928
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019	7,910,605
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019	7,910,605

International Patents for pitolisant hydrochloride

Country	Patent Number	Title	Estimated Expiration
Ukraine	94902	ЛЕЧЕНИЕ БОЛЕЗНИ ПАРКИНСОНА, ОБСТРУКТИВНОГО АПНОЕ СНА, ДЕМЕНЦИИ С ТЕЛЬЦАМИ ЛЕВИ, СОСУДИСТОЙ ДЕМЕНЦИИ НЕИМИДАЗОЛЬНЫМИ АЛКИЛАМИНАМИ, КОТОРЫЕ ЯВЛЯЮТСЯ ЛИГАНДАМИ H3-РЕЦЕПТОРА ГИСТАМИНА;ЛІКУВАННЯ ХВОРОБИ ПАРКІНСОНА, ОБСТРУКТИВНОГО АПНОЕ СНУ, ДЕМЕНЦІЇ З ТІЛЬЦЯМИ ЛЕВІ, СУДИННОЇ ДЕМЕНЦІЇ НЕІМІДАЗОЛЬНИМИ АЛКІЛАМІНАМИ, ЯКІ Є ЛІГАНДАМИ H3-РЕЦЕПТОРА ГІСТАМІНУ (TREATMENT OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS)
Japan	5546761
South Korea	101308527
Croatia	P20130748
Japan	2014062126	TREATMENT OF SYMPTOMS OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINE HISTAMINE H3-RECEPTOR LIGANDS

Supplementary Protection Certificates for pitolisant hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1428820	2016/038	Ireland		PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	16C0038	France		PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	SPC/GB16/052	United Kingdom		PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTERED: UK EU/1/15/1068 20160404
1428820	1690039-1	Sweden		PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE.; REG. NO/DATE: EU/15/1068 20160404
1428820	122016000073	Germany		PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331

Market Dynamics and Financial Trajectory for Pitolisant Hydrochloride

Last updated: July 29, 2025

Introduction

Pitolisant hydrochloride, marketed under brand names such as Wakix®, is a novel pharmacological agent approved for the treatment of narcolepsy with or without cataplexy. As a selective histamine H3 receptor antagonist/inverse agonist, pitolisant represents a significant shift in the management of central nervous system disorders, particularly sleep-wake regulation. This analysis explores the contemporary market dynamics driving its adoption and the anticipated financial trajectory, considering factors from regulatory landscapes to competitive positioning.

Pharmacological Profile and Clinical Efficacy

Pitolisant’s unique mechanism—enhancing histaminergic neurotransmission—addresses the core pathophysiological deficits in narcolepsy, notably excessive daytime sleepiness. Clinical trials have demonstrated its efficacy in improving wakefulness and reducing cataplexy episodes, positioning it as an effective alternative to traditional stimulants and sodium oxybate therapies. The drug’s favorable safety profile and minimal abuse potential have bolstered its clinical acceptance, further influencing market momentum ([1]).

Market Penetration and Adoption Drivers

Regulatory Milestones and Approvals

Germany’s approval in 2016 marked the initial market entry, followed by the U.S. Food and Drug Administration (FDA) approval in August 2019. Subsequent approvals in Europe and other regions have expanded its geographic footprint, increasing accessibility. Regulatory support—highlighted by efficient review processes and favorable safety data—has facilitated early adoption in key markets. Ongoing post-market surveillance continues to reinforce its safety credentials, essential for broader acceptance.

Market Acceptance and Clinical Adoption

Physicians and sleep clinics increasingly recognize pitolisant as a first-line or adjunct therapy. Its unique mechanism attracts neurologists and sleep specialists seeking alternatives to stimulants that carry abuse potential and cardiovascular risks. The shift from traditional stimulants to histamine modulation is gaining momentum, driven by empirical evidence and patient preference for better tolerability.

Competitive Landscape

The narcolepsy treatment market is currently dominated by stimulants, sodium oxybate, and emerging agents like solriamfetol. Pitolisant’s differentiated profile positions it favorably among these options—particularly for patients contraindicated for stimulants or experiencing adverse effects. However, rapid growth depends on ongoing clinical validation, physician education, and formulary inclusion.

Market Size and Revenue Projections

Current Market Valuation

The global narcolepsy therapeutics market was valued at approximately USD 650 million in 2022, with estimates suggesting a compound annual growth rate (CAGR) of around 8% through 2030 ([2]). Pitolisant’s contribution remains modest but has shown promising uptake in the U.S., where its introduction captured a notable market share within early adopters.

Forecasted Financial Trajectory

By 2030, the market for narcolepsy drugs is projected to surpass USD 1.2 billion, fueled by increased diagnoses, improved awareness, and expanding indications. Pitolisant’s market share is anticipated to grow as clinicians favor it for its efficacy, safety, and mechanism of action. Conservative estimates project pitolisant could approximate USD 300–400 million in global sales by 2030, contingent on continued approvals and formulary placements ([3]).

Factors Influencing Revenue Growth

• Geographic expansion: Regulatory approvals outside North America and Europe open sizeable markets, especially in Asia-Pacific regions with rising sleep disorder prevalence.
• New indications: Potential off-label uses or expanded indications could augment sales.
• Pricing dynamics: As a branded drug, pricing strategies and reimbursement policies significantly impact revenues.
• Competitive innovations: Emergence of generics or alternative therapies may pressure prices but also stimulate market growth through increased diagnosis rates.

Market Challenges and Risks

Regulatory and Reimbursement Hurdles

Variable payer landscapes and restrictive reimbursement policies pose barriers to access, affecting overall market penetration. Future regulatory mandates regarding safety monitoring could influence prescribing patterns.

Competitive Pressures

Entry of biosimilars, generics, or competing novel agents could erode market share. Real-world evidence favoring other agents may influence prescriber preferences.

Limited Indication Spectrum

Currently approved solely for narcolepsy, expansion into other sleep disorders remains uncertain, potentially capping the market size.

Strategic Considerations for Stakeholders

• Investors should monitor regulatory developments, expanding indications, and partnerships that enhance distribution.
• Pharmaceutical companies need to prioritize post-marketing studies to bolster safety data, support strategic alliances, and engage in physician education.
• Healthcare policymakers influence market access through reimbursement policies; engagement is vital for widespread adoption.

Conclusion

Pitolisant hydrochloride’s trajectory in the global sleep disorder market is promising, underpinned by its novel mechanism, favorable safety profile, and expanding regulatory landscape. While challenges exist, strategic positioning and clinical validation can propel its revenue toward projected milestones. Continued research, geographical expansion, and demonstration of real-world benefits are critical to maximizing its financial potential.

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Key Takeaways

• Market expansion hinges on gaining regulatory approvals across diverse geographies and establishing comprehensive reimbursement coverage.
• Clinical awareness and physician adoption are crucial; targeted education can accelerate usage growth.
• Competitive positioning requires highlighting pitolisant’s unique mechanism and safety advantages over traditional therapies.
• Financial projections suggest potential revenues of USD 300–400 million globally by 2030, driven by increased diagnoses and expanded access.
• Strategic partnerships and ongoing clinical research will be instrumental in sustaining growth and optimizing market share.

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FAQs

1. What is the primary therapeutic indication for pitolisant hydrochloride?
   It is primarily indicated for the treatment of narcolepsy with or without cataplexy, improving wakefulness and reducing attack episodes.

2. How does pitolisant differ from traditional narcolepsy treatments?
   Unlike stimulants, pitolisant acts as a selective H3 receptor inverse agonist, enhancing histamine release without stimulant-related side effects or abuse potential.

3. What are the main barriers to its global market expansion?
   Regulatory hurdles, reimbursement challenges, and limited indication spectrum are key obstacles to broader adoption.

4. How is the competitive landscape influencing pitolisant’s financial outlook?
   Competition from stimulants and sodium oxybate, alongside upcoming agents, could affect market share; however, its distinct profile offers differentiation.

5. What is the long-term revenue potential for pitolisant?
   Predicted to reach USD 300–400 million globally by 2030, contingent on regulatory approvals, market acceptance, and potential new indications.

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References

[1] Scammell TE. (2018). Pharmacology of Narcolepsy: New Advances. Sleep Medicine Reviews.
[2] MarketsandMarkets. (2022). Sleep Disorders Therapeutics Market Forecast.
[3] GlobalData. (2023). Narcolepsy Drugs Market Outlook.