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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 211150


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NDA 211150 describes WAKIX, which is a drug marketed by Harmony and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the WAKIX profile page.

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.
Summary for 211150
Tradename:WAKIX
Applicant:Harmony
Ingredient:pitolisant hydrochloride
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211150
Generic Entry Date for 211150*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 211150
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WAKIX pitolisant hydrochloride TABLET;ORAL 211150 NDA Harmony Biosciences, LLC 72028-045 72028-045-03 1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
WAKIX pitolisant hydrochloride TABLET;ORAL 211150 NDA Harmony Biosciences, LLC 72028-178 72028-178-03 1 BOTTLE, PLASTIC in 1 CARTON (72028-178-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4.45MG BASE
Approval Date:Aug 14, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 14, 2026
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULT PATIENTS WITH NARCOLEPSY
Regulatory Exclusivity Expiration:Aug 14, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 13, 2027
Regulatory Exclusivity Use:TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY

Expired US Patents for NDA 211150

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.