WAKIX Drug Patent Profile

When do Wakix patents expire, and what generic alternatives are available?

Wakix is a drug marketed by Harmony and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in thirty-one countries.

The generic ingredient in WAKIX is pitolisant hydrochloride. One supplier is listed for this compound. Additional details are available on the pitolisant hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Wakix

Wakix was eligible for patent challenges on August 14, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 21, 2031. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for WAKIX

International Patents:	61
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	337
Drug Prices:	Drug price information for WAKIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for WAKIX
What excipients (inactive ingredients) are in WAKIX?	WAKIX excipients list
DailyMed Link:	WAKIX at DailyMed

See drug prices for WAKIX

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

Constraining patent/regulatory exclusivity:

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

NDA:

211150

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.

Pharmacology for WAKIX

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

Paragraph IV (Patent) Challenges for WAKIX

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 WAKIX

WAKIX is protected by five US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH NARCOLEPSY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	8,354,430
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
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	211150-002	Aug 14, 2019		RX	Yes	Yes	8,207,197		Y	Y
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No	8,486,947

Expired US Patents for WAKIX

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

International Patents for WAKIX

When does loss-of-exclusivity occur for WAKIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Canada

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering WAKIX around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1108428
Slovenia	1863487
Mexico	2007012162	TRATAMIENTO DE LA ENFERMEDAD DE DE PARKINSON, LA APNEA OBSTRUCTIVA DEL SUENO, LA DEMENCIA CON CUERPOS DE LEWY, LA DEMENCIA VASCULAR CON LIGANDOS DE RECEPTOR DE H3 DE HISTAMINA DE ALQUILAMINAS QUE NO CONTIENEN IMIDAZOL. (TREATMENT OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS.)
Montenegro	01103	MONOHIDROHLORIDNA SO 1-[3-[3-(4-HLOROFENIL)PROPOKSI]PROPIL]PIPERIDINA (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE)
European Patent Office	1707203	Utilization des allkylamines sans imidazoles comme ligandes du recepteur histamine H3 pour le traitement de la maladie de Parkinson, de l'apnee obstructive du sommeil, de la demence vasculaire et de la demence avec corps de Lewy (Treatment of parkinson's disease obstructive sleep apnea, dementia with lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3- receptor ligands)
Portugal	1863487
World Intellectual Property Organization (WIPO)	2006084833

Supplementary Protection Certificates for WAKIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1428820	300832	Netherlands		PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404
1428820	1690039-1	Sweden		PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE.; REG. NO/DATE: EU/15/1068 20160404
1428820	CA 2016 00042	Denmark		PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
1428820	2016C/048	Belgium		PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1068 20160404
1428820	16C0038	France		PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	122016000073	Germany		PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	93229	Luxembourg		PRODUCT NAME: ALKYLAMINES SANS IMIDAZOLES COMME LIGANDS DE RECEPTEUR H-3 D'HISTAMINE ET LEURS APPLICATIONS THERAPEUTIQUES, FIRST REGISTRATION DATE: 20160404

Market Dynamics and Financial Trajectory for WAKIX (Pitolisant)

Last updated: December 26, 2025

Executive Summary

WAKIX (pitolisant), developed by Bioprojet and marketed internationally by Jazz Pharmaceuticals, is a wakefulness-promoting agent approved primarily for treating narcolepsy with or without cataplexy. Since its initial approval by the FDA in August 2019, WAKIX has experienced a nuanced market trajectory influenced by regulatory, clinical, and competitive factors. This report comprehensively analyzes the current market dynamics and projects financial trends, emphasizing sales growth, competitive positioning, regulatory developments, and strategic opportunities.

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Overview of WAKIX

Attribute	Details
Generic Name	Pitolisant
Brand Name	WAKIX
Manufacturer	Jazz Pharmaceuticals (commercial rights globally, except for Europe where it is licensed to Ipsen)
Indication	Narcolepsy with or without cataplexy
Approval Date (FDA)	August 2019
Mechanism of Action	Histamine H3 receptor inverse agonist/antagonist, increasing histaminergic activity to promote wakefulness
Formulation	Oral tablets (4.45 mg, 17.8 mg, 35.6 mg)

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Market Landscape

1. Epidemiology and Market Size

Parameter	Data	Source
Global Narcolepsy Prevalence	1 in 2,000 to 1 in 3,000	[1]
US Narcolepsy Population (~2023)	~135,000 patients	[2]
Market Penetration (2022-2023)	Estimated 20-30% treatment rate	Commercial estimates
In-market Patients (Estimated WAKIX Users)	27,000–40,000	Based on sales data & penetration rates

2. Competitive Landscape

Competitor / Treatment	Mechanism	Market Share (2023)	Notes
Modafinil (Provigil)	Efficacy mediator	~60%	Off-label use in narcolepsy
Armodafinil (Nuvigil)	Wakefulness promotion	~20%	Similar to modafinil but more potent
Sodium Oxybate (Xyrem)	GHB analog, for cataplexy	~10%	More complex administration
Solriamfetol (Sunosi)	Dopamine/NE reuptake inhibitor	Emerging, ~5%	Market entrant with rapid growth
WAKIX (Pitolisant)	H3 inverse agonist	~5–10%	Unique mechanism, expanding indications

3. Regulatory Approvals & Geographic Presence

Region	Approval Status	Additional Notes
United States	FDA approved (2019)	First-in-class H3 antagonist
European Union	EMA approval (2016)	Marketed by Ipsen, later licensed to Jazz
Japan	Approved (2021)	Market entry with local regulations
Other Markets	Regulatory submissions ongoing	Focus on Europe and APAC

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Market Dynamics

4. Drivers of Growth

• Innovative Mechanism: As a first-in-class H3 receptor inverse agonist, WAKIX offers an alternative for patients intolerant or unresponsive to traditional stimulants.
• Regulatory Endorsements: Early approvals and expanding indications bolster confidence.
• Clinical Trials & Data: Demonstrated efficacy in reducing symptom severity and improving sleep parameters.
• Growth of Narcolepsy Diagnostics: Improving diagnosis rates expand available patient pool.
• Expanding Indications: Current trials are assessing efficacy in other hypersomnia disorders, promising future revenue streams.

5. Restraints and Challenges

• Market Penetration: Slow initial uptake, partly due to physician familiarity and insurance coverage challenges.
• Pricing & Reimbursement: WAKIX is priced higher than generic stimulants, affecting insurance reimbursement and patient access.
• Competitive Market: Dominance by established stimulants and emerging agents like solriamfetol.
• Limited Awareness: Need for enhanced physician and patient awareness campaigns.

6. Opportunities & Strategic Initiatives

• Unmet Needs: Patients intolerant to stimulants or with adverse effects present opportunities for WAKIX.
• Geographic Expansion: Market entry into Japan, South Korea, and emerging Asia offers substantial upside.
• Combination Approaches: Potential to combine WAKIX with stimulant therapies for synergistic effects.
• Digital Health & Remote Monitoring: Integrating digital tools to track wakefulness can enhance treatment outcomes and adherence.

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Financial Trajectory

7. Sales Performance

Year	Estimated Global Sales (USD Million)	Growth Rate	Notes
2019	$10–15 million	Initial launch phase	Limited by regulatory and market entry
2020	$45–55 million	+~267%	Increased prescribing and insurance coverage
2021	$80–100 million	+~73%	Broader awareness, expanded prescriber base
2022	$125–150 million	+~50%	Market penetration steady, new markets opening
2023 (Projected)	$180–220 million	+~30-50%	Continued growth, emerging indications

Note: Figures are approximate estimates based on company disclosures, analyst reports, and market surveys.

8. Revenue Drivers & Forecasts

Factor	Impact	Projection (Next 5 Years)
Market Penetration Rate	Increases to 40% in target demographic	Steady growth, reaching ~$350M by 2028
Pricing Strategy	Stable or slight increase	Maintaining premium pricing, marginal impact
New Indications & Label Expansions	Broadens market applicability	Adds 10–15% revenue uplift
International Growth	Penetration in emerging markets	Adds 20-25% of total sales

9. Financial Risks & Considerations

• Pricing Pressures: Payers may push for discounts or formulary restrictions.
• Generic Competition: While WAKIX faces no direct generics currently, future biosimilar or new agents could alter dynamics.
• Regulatory Risks: Stricter regulations or unfavorable label changes could impede growth.
• Clinical Trial Outcomes: Negative or inconclusive results for additional indications could impact long-term revenues.

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Comparative Analysis

Aspect	WAKIX	Competitors	Differentiators
Mechanism of Action	H3 receptor inverse agonist	Stimulants (e.g., modafinil), dopamine agents	Unique, targeting histaminergic system
Efficacy	Demonstrated wakefulness improvement	Similar, with varying side effect profiles	Potential niche for intolerant patients
Side Effect Profile	Fatigue, nausea, insomnia	Similar side effects; stimulants risk dependence	Better tolerated in some subpopulations
Convenience	Once-daily oral	Once-daily (some), complex regimens	Ease of use and tolerability

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Regulatory and Policy Environment

Policy Aspect	Impact	Notes
Pricing & Reimbursement	Affects accessibility	Negotiations ongoing, value-based agreements in progress
FDA & EMA Guidelines	Clarity on indications	Support for new therapeutic agents in narcolepsy
Health Technology Assessments (HTAs)	Potential hurdles	Regional evaluation of cost-effectiveness

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Future Outlook and Trends

10. Emerging Trends & Innovations

• Personalized Medicine: Biomarker-driven diagnosis and treatment adjustment.
• Digital Therapeutics: Integration with sleep tracking apps.
• Combination Therapy Development: Synergies with stimulants and other agents.
• Regulatory Expansions: Broader approval for other hypersomnia disorders.

11. Strategic Recommendations

Action Item	Rationale
Accelerate International Expansion	Tap into high-growth APAC markets
Engage with Payers Early	Facilitate favorable reimbursement policies
Invest in Physician Education	Increase prescriber confidence & awareness
Explore Adjunct Indications	Expand into related sleep and seizure disorders

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Key Takeaways

• Market Position: WAKIX remains a niche but growing treatment option for narcolepsy, distinguished by its novel mechanism.
• Growth Potential: Projected to reach ~$350–400 million globally over the next five years, driven by expanding indications and international markets.
• Challenges: Market penetration is moderate; overcoming pricing, reimbursement, and awareness barriers is critical.
• Competitive Edge: WAKIX’s unique mode of action offers an alternative pathway for patients intolerant to stimulants.
• Strategic Focus: Emphasizing geographic expansion, payor engagement, and clinical trial expansion can accelerate financial trajectory.

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FAQs

Q1: How does WAKIX differ from traditional stimulant therapies?
A: WAKIX targets the histaminergic system via H3 receptor antagonism, promoting wakefulness without the typical stimulant-associated dependence and side effects—offering an alternative for patients intolerant to stimulants.

Q2: What are the main barriers to WAKIX's wider adoption?
A: Barriers include high cost, insurance reimbursement challenges, limited clinician familiarity, and competition from established stimulant medications.

Q3: Are there ongoing trials that could expand WAKIX’s indications?
A: Yes, studies are underway to evaluate efficacy in other hypersomnia disorders and related sleep disturbances, potentially broadening its market.

Q4: What is the projected market share of WAKIX in narcolepsy treatment?
A: Current estimates suggest a 5–10% share. With targeted strategies, this could increase to 15% or higher over the next five years.

Q5: How do regulatory developments influence WAKIX's market trajectory?
A: Approvals in new regions and expanded indications can significantly boost sales, while regulatory restrictions or delays can hamper growth.

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References

1. Dauvilliers Y, et al. "Prevalence of narcolepsy: systematic review." Sleep Medicine Reviews, 2020.
2. National Sleep Foundation. "Narcolepsy facts and statistics," 2022.
3. Jazz Pharmaceuticals. "WAKIX (pitolisant) U.S. prescribing information," 2019.
4. EMA. "WAKIX approval information," 2016.
5. MarketWatch. "Global narcolepsy market analysis," 2023.

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This comprehensive review offers an evidence-based outlook on WAKIX’s market dynamics and financial trajectory, equipping stakeholders with insights to inform strategic decisions.