Pitolisant Hydrochloride | All | Licensing, EU CTD Dossiers, Formulation Suppliers | PharmaCompass.com

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Pitolisant Hydrochloride
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Pitolisant Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 7 USDMF, 2 EU WC, 6 NDC API, 8 Listed Suppliers, $ API Reference Price

11 API Suppliers
7 USDMF
2 EU WC
6 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

34 Drugs in Development

34 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

16 FDF Dossiers, 4 FDA Orange Book, 10 Europe, 2 Canada

16 FDF Dossiers
4 FDA Orange Book
10 Europe
2 Canada

DIGITAL CONTENT

40 News #PharmaBuzz

40 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

1 US Medicaid Prescriptions

MARKET PLACE

8 APIs

8 APIs

PATENTS & EXCLUSIVITIES

10 US Patents, 8 US Exclusivities, 4 Health Canada Patents

10 US Patents
8 US Exclusivities
4 Health Canada Patents

$ API Ref.Price (USD/KG) : 11,750 Xls

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16 All

01 1Annora Pharma

02 8Bioprojet Pharma

03 2ENDO OPERATIONS LTD.

04 2Future Health Pharma Gmbh

05 2Harmony Biosciences

06 1MSN Laboratories

filter Dosage Reset all filters

16 All

01 10Film Coated Tablet

02 3TABLET

03 1TABLET; FILM COATED

04 2TABLET;ORAL

filter Regulatory Info Reset all filters

16 All

01 2Allowed

02 4Approved

03 4Authorized

04 2Prescription

05 2RX

06 2Blank

filter Brand Name Reset all filters

16 All

01 4Ozawade

02 2PITOLISANT

03 4WAKIX

04 6Wakix

filter Country Reset all filters

16 All

01 2Canada

02 4Spain

03 4Sweden

04 2Switzerland

05 4USA

HRV Pitolisant Hydrochloride

List of Suppliers

Product Main Page

01

Annora Pharma

AIChE Annual Meeting

Not Confirmed

Annora Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : USA

Brand Name : PITOLISANT

Dosage Form : TABLET

Dosage Strength : 17.8MG

Packaging :

Approval Date :

Application Number : 218832

Regulatory Info :

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Pitolisant Hydrochloride

Brand Name : Ozawade

Dosage Form : Film Coated Tablet

Dosage Strength : 18mg

Packaging :

Approval Date : 22/07/2021

Application Number : 20191110000029

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Pitolisant Hydrochloride

Brand Name : Ozawade

Dosage Form : Film Coated Tablet

Dosage Strength : 4.5mg

Packaging :

Approval Date : 22/07/2021

Application Number : 20191110000012

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Pitolisant Hydrochloride

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 18mg

Packaging :

Approval Date : 31/03/2016

Application Number : 20140610000015

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Pitolisant Hydrochloride

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 4.5mg

Packaging :

Approval Date : 31/03/2016

Application Number : 20151003000024

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Pitolisant Hydrochloride

Brand Name : Ozawade

Dosage Form : Film Coated Tablet

Dosage Strength : 4.5MG

Packaging :

Approval Date : 2021-11-11

Application Number : 1211546001

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Pitolisant Hydrochloride

Brand Name : Ozawade

Dosage Form : Film Coated Tablet

Dosage Strength : 18MG

Packaging :

Approval Date : 2021-11-11

Application Number : 1211546002

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 4.5MG

Packaging :

Approval Date : 2016-09-03

Application Number : 1151068001

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

Bioprojet Pharma

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 18MG

Packaging :

Approval Date : 2016-08-03

Application Number : 1151068002

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Harmony Biosciences

AIChE Annual Meeting

Not Confirmed

Harmony Biosciences

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : RX

Registration Country : USA

PITOLISANT HYDROCHLORIDE

Brand Name : WAKIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4.45MG BASE

Packaging :

Approval Date : 2019-08-14

Application Number : 211150

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

11

Harmony Biosciences

AIChE Annual Meeting

Not Confirmed

Harmony Biosciences

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : RX

Registration Country : USA

PITOLISANT HYDROCHLORIDE

Brand Name : WAKIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 17.8MG BASE

Packaging :

Approval Date : 2019-08-14

Application Number : 211150

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

12

MSN Laboratories

AIChE Annual Meeting

Not Confirmed

MSN Laboratories

AIChE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : USA

Brand Name : PITOLISANT

Dosage Form : TABLET; FILM COATED

Dosage Strength : 4.45MG

Packaging :

Approval Date :

Application Number : 218873

Regulatory Info :

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

13

Future Health Pharma Gmbh

Country

AIChE Annual Meeting

Not Confirmed

Future Health Pharma Gmbh

Country

AIChE Annual Meeting

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 4.45mg

Packaging :

Approval Date : 20/12/2018

Application Number : 67007

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

14

Future Health Pharma Gmbh

Country

AIChE Annual Meeting

Not Confirmed

Future Health Pharma Gmbh

Country

AIChE Annual Meeting

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 17.8mg

Packaging :

Approval Date : 20/12/2018

Application Number : 67007

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

15

ENDO OPERATIONS LTD.

Country

AIChE Annual Meeting

Not Confirmed

ENDO OPERATIONS LTD.

Country

AIChE Annual Meeting

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

PITOLISANT HYDROCHLORIDE

Brand Name : WAKIX

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2516241

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

16

ENDO OPERATIONS LTD.

Country

AIChE Annual Meeting

Not Confirmed

ENDO OPERATIONS LTD.

Country

AIChE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Country

Virtual Booth

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

PITOLISANT HYDROCHLORIDE

Brand Name : WAKIX

Dosage Form : TABLET

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 2516268

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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