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.
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:
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.
Pharmacology for NDA: 211150
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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4.45MG BASE | ||||
| Approval Date: | Aug 14, 2019 | TE: | 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: | Jun 21, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| 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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | ⤷ Get Started Free | ⤷ Get Started Free |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | ⤷ Get Started Free | ⤷ Get Started Free |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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