PITOLISANT HYDROCHLORIDE - Generic Drug Details

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What are the generic 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:	28
Patent Applications:	9
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

Generic Entry Date for PITOLISANT HYDROCHLORIDE^: ⤷ Sign Up* 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
University of Oxford	N/A
William Ondo, MD	Phase 4
Harmony Biosciences, LLC	Phase 4

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

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Glossary

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

Expired US Patents for PITOLISANT HYDROCHLORIDE

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

International Patents for PITOLISANT HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Japan	5546761		⤷ Sign Up
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)	⤷ Sign Up
Denmark	1846384		⤷ Sign Up
Canada	2603656	TRAITEMENT DE LA MALADIE DE PARKINSON, DE L'APNEE OBSTRUCTIVE DU SOMMEIL, DE LA DEMENCE AVEC CORPS DE LEWY, DE LA DEMENCE VASCULAIRE, AVEC DES LIGANDS DU RECEPTEUR H3 D'HISTAMINE A ALKYLAMINES NON IMIDAZOLES (TREATMENT OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS)	⤷ Sign Up
Eurasian Patent Organization	200702135	ЛЕЧЕНИЕ БОЛЕЗНИ ПАРКИНСОНА, ОБСТРУКТИВНОГО СИНДРОМА АПНОЭ ВО СНЕ, СЛАБОУМИЯ С ТЕЛЬЦАМИ ЛЬЮИ, СОСУДИСТОЙ ДЕМЕНЦИИ С ПОМОЩЬЮ НЕ СОДЕРЖАЩИХ ИМИДАЗОЛА АЛКИЛАМИНОВЫХ ЛИГАНДОВ ГИСТАМИНОВЫХ Н3-РЕЦЕПТОРОВ	⤷ Sign Up
South Africa	200708086	Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PITOLISANT HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1428820	CR 2016 00042	Denmark	⤷ Sign Up	PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
1428820	2016/038	Ireland	⤷ Sign Up	PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	16C0038	France	⤷ Sign Up	PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	122016000073	Germany	⤷ Sign Up	PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	2016C/048	Belgium	⤷ Sign Up	PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1068 20160404
1428820	CA 2016 00042	Denmark	⤷ Sign Up	PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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