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 three 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:	95
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
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

Expired US Patents for WAKIX

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

International Patents for WAKIX

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

Country	Patent Number	Title	Estimated Expiration
Japan	2008534572
World Intellectual Property Organization (WIPO)	2006084833
Serbia	50624	MONOHIDROHLORIDNA SO 1-[3-[3-(4-HLOROFENIL)PROPOKSI]PROPIL]PIPERIDINA (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE)
Mexico	2007009574	SAL DE MONOCLORHIDRATO DE 1-[3-[3-(4-CLOROFENIL)PROPOXI]-PROPIL]- PIPERIDINA. (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE.)

Supplementary Protection Certificates for WAKIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	499	Finland
1428820	16C0038	France		PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	CR 2016 00042	Denmark		PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404

Market Dynamics and Financial Trajectory for WAKIX

Introduction

WAKIX (pitolisant), developed and marketed by Harmony Biosciences, has emerged as a significant player in the treatment of narcolepsy and other sleep-related disorders. Here, we delve into the market dynamics and financial trajectory of WAKIX, highlighting its growth, clinical advancements, and future prospects.

Approval and Mechanism of Action

WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist, approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. It was granted orphan drug designation for narcolepsy in 2010 and breakthrough therapy designation for cataplexy in 2018[1][3].

Market Performance

Since its commercial launch in Q4 2019, WAKIX has demonstrated robust growth. Here are some key financial highlights:

Revenue Growth

• In the fourth quarter of 2023, WAKIX generated net revenue of approximately $168.4 million, marking a 31% increase from the same period in 2022. For the full year 2023, net revenue was $582 million, a 33% increase from 2022[1][2].
• As of September 2024, WAKIX has surpassed $2 billion in cumulative net revenue since its launch, with the third quarter of 2024 alone seeing $186 million in net revenue[4][5].

Patient and Prescriber Growth

• The average number of patients on WAKIX increased to approximately 6,150 in the fourth quarter of 2023 and further to around 6,800 by the end of September 2024. This growth is supported by robust payer coverage and a broad prescriber base of about 9,000 healthcare professionals[1][4].

Clinical Development and Pipeline

Harmony Biosciences is actively expanding its clinical development programs for WAKIX and other pitolisant-based formulations:

Current Indications

• WAKIX is currently approved for adult narcolepsy and is under priority review by the FDA for pediatric narcolepsy, with a decision expected by June 21, 2024[2].

Future Indications

• The company is advancing several new indications, including idiopathic hypersomnia, Prader-Willi syndrome, and Myotonic Dystrophy Type 1. An sNDA for idiopathic hypersomnia is planned for submission in Q4 2024[1][3][4].

Next-Generation Formulations

• Harmony is developing next-generation formulations of pitolisant, including high-dose and gastro-resistant versions, aimed at providing enhanced pharmacokinetic profiles and higher dosage ranges to drive greater efficacy. These innovations are expected to extend the pitolisant franchise beyond 2040[3][4].

Financial Outlook

Revenue Projections

• For 2024, Harmony Biosciences projects net product revenue for WAKIX to be between $700 million and $720 million, driven primarily by volume growth[1][2][5].

Cash Position and Share Repurchases

• The company maintains a strong cash position, with $425.6 million in cash, equivalents, and investment securities as of the end of 2023. Harmony also continues its share repurchase program, with $150 million remaining authorized for repurchases as of September 30, 2024[2][5].

Market Dynamics and Competition

Market Opportunity

• The narcolepsy market in the U.S. is significant, with approximately 80,000 diagnosed patients. WAKIX's broad clinical utility and strong prescriber base position it well to tap into this large market opportunity[4].

Competitive Landscape

• Despite competition from generic and once-nightly oxybate products, WAKIX has continued to grow, driven by its differentiated product profile and broad clinical utility. Harmony does not foresee any new mechanisms of action impacting WAKIX's growth until late in its life cycle[2].

Key Takeaways

• Revenue Growth: WAKIX has achieved significant revenue growth, surpassing $2 billion in cumulative revenue since its launch.
• Clinical Advancements: The drug is being explored for additional indications, including idiopathic hypersomnia, Prader-Willi syndrome, and Myotonic Dystrophy Type 1.
• Pipeline Expansion: Next-generation formulations are in development to enhance efficacy and extend the franchise.
• Financial Strength: Harmony Biosciences maintains a strong cash position and continues its share repurchase program.
• Market Position: WAKIX remains a leader in the narcolepsy market, with a broad prescriber base and robust payer coverage.

FAQs

Q: What is WAKIX used for?

A: WAKIX (pitolisant) is used for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.

Q: How has WAKIX performed financially since its launch?

A: Since its launch in Q4 2019, WAKIX has generated over $2 billion in cumulative revenue, with a 31% increase in Q4 2023 and a 33% increase for the full year 2023 compared to the previous year.

Q: What are the future clinical development plans for WAKIX?

A: Harmony Biosciences is advancing WAKIX for additional indications such as idiopathic hypersomnia, Prader-Willi syndrome, and Myotonic Dystrophy Type 1, and is developing next-generation formulations.

Q: How does WAKIX compete in the market?

A: Despite competition from generic and once-nightly oxybate products, WAKIX's differentiated product profile and broad clinical utility have enabled it to maintain strong growth.

Q: What is Harmony Biosciences' financial outlook for 2024?

A: Harmony Biosciences projects net product revenue for WAKIX to be between $700 million and $720 million for 2024, driven primarily by volume growth.

Sources

1. Harmony Biosciences Preliminary Unaudited Fourth Quarter and Full Year 2023 Net Product Revenue - PR Newswire
2. Earnings call: Harmony Biosciences reports 2023 growth driven by WAKIX - Investing.com
3. Harmony Biosciences Acknowledges US Food and Drug Administration (FDA) - Investor Relations | Harmony Biosciences
4. Harmony's Wakix Surpasses $2B in Revenue - Sleep Review
5. Harmony Biosciences Reports Strong Third Quarter 2024 Financial Results - Investor Relations | Harmony Biosciences