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1. 903576-44-3
2. Ciproxidine
3. Bf 2649
4. Pitolisant Hcl
5. Pitolisant (hydrochloride)
6. Bf 2649 Hydrochloride
7. Yv33ch63hi
8. Pitolisant Hydrochloride [usan]
9. 1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine Hydrochloride
10. Piperidine, 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-, Hydrochloride
11. 903576-44-3 (hcl)
12. Wakix (tn)
13. Pitolisant Hydrochloride (usan)
14. 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine Hydrochloride
15. 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine Hydrochloride
16. Piperidine, 1-(3-(3-(4-chlorophenyl)propoxy)propyl)-, Hydrochloride
17. Bf 2.649
18. Unii-yv33ch63hi
19. Schembl4591893
20. Bf-2649 Hydrochloride
21. Chembl4164059
22. Dtxsid50238098
23. Pitolisant;ciproxidine; Bf2649
24. Amy23423
25. Bcp16427
26. Ex-a1420
27. Hy-12199b
28. Pitolisant Hydrochloride [mi]
29. S5926
30. Akos024457784
31. Cs-1501
32. Sb17036
33. Pitolisant Hydrochloride [who-dd]
34. Ac-36017
35. As-72196
36. A3727
37. Pitolisant Hydrochloride [orange Book]
38. C77058
39. D11490
40. A900088
41. Q27895485
42. 1-[3-[3-(4-chlorophenyl)propoxy]propyl]piperidine;hydrochloride
43. 1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine Monohydrochloride
44. Piperidine, 1-(3-(3-(4-chlorophenyl)propoxy)propyl)-, Hydrochloride (1:1)
Molecular Weight | 332.3 g/mol |
---|---|
Molecular Formula | C17H27Cl2NO |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 8 |
Exact Mass | 331.1469699 g/mol |
Monoisotopic Mass | 331.1469699 g/mol |
Topological Polar Surface Area | 12.5 Ų |
Heavy Atom Count | 21 |
Formal Charge | 0 |
Complexity | 235 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39721
Submission : 2024-04-01
Status : Active
Type : II
Available Reg Filing : AU |
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-31
Pay. Date : 2023-03-15
DMF Number : 36859
Submission : 2022-03-01
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-084
Start Marketing Date : 2021-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-28
Pay. Date : 2023-07-06
DMF Number : 37753
Submission : 2022-12-31
Status : Active
Type : II
NDC Package Code : 73435-034
Start Marketing Date : 2023-12-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38174
Submission : 2023-03-30
Status : Active
Type : II
NDC Package Code : 58159-084
Start Marketing Date : 2021-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-22
Pay. Date : 2024-07-25
DMF Number : 39126
Submission : 2023-12-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-17
Pay. Date : 2023-04-25
DMF Number : 38131
Submission : 2023-03-27
Status : Active
Type : II
NDC Package Code : 14501-0114
Start Marketing Date : 2023-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-22
Pay. Date : 2023-04-21
DMF Number : 38307
Submission : 2023-05-09
Status : Active
Type : II
NDC Package Code : 70966-0038
Start Marketing Date : 2019-08-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
About the Company : Emnar Pharma was established in 2005, with a drive to become the premier integrated pharmaceuticals company in India. Its business focuses on Contract Manufacturing, Custom Synthes...
About the Company : Virchow Group comprises of six active pharmaceutical ingredient (API) and drug intermediate manufacturing units and two biotech units. Incorporated in 1981, the flagship company of...
Details:
Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Brand Name: Wakix
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2024
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
HARMONY BIOSCIENCES Receives FDA Approval for WAKIX® in Pediatric Narcolepsy
Details : Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 24, 2024
Details:
Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Wakix
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2024
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Harmony Biosciences Begins Global Phase 3 Trial of Pitolisant for Prader-Willi Syndrome
Details : Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 03, 2024
Details:
Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Wakix
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2024
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Harmony Receives Orphan Drug Designation for Pitolisant in Prader-Willi Syndrome
Details : Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 20, 2024
Details:
Wakix (pitolisant HCl) is a 5-HT3 receptor Inhibitor Small molecule drug candidate, which is currently being evaluated for the treatment of adult patients with myotonic dystrophy type 1.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Wakix
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2023
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Wakix (pitolisant HCl) is a 5-HT3 receptor Inhibitor Small molecule drug candidate, which is currently being evaluated for the treatment of adult patients with myotonic dystrophy type 1.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 07, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Brand Name: Wakix
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2023
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 13, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Brand Name: Wakix
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2023
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 07, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for Prader-Willi Syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Wakix
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2023
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for Prader-Willi Syndrome.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 20, 2023
Details:
Wakix (pitolisant) is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which was granted orphan drug designation for the treatment of narcolepsy by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Brand Name: Wakix
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 04, 2023
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
China NMPA Approves RareStone's Pitolisant (Wakix) for the Treatment of Narcolepsy
Details : Wakix (pitolisant) is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which was granted orphan drug designation for the treatment of narcolepsy by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 04, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse, which is used for Prader-Willi Syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Wakix
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2023
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse, which is used for Prader-Willi Syndrome.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 06, 2023
Details:
Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Brand Name: Wakix
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.
Brand Name : Wakix
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 25, 2023
RLD : Yes
TE Code :
Brand Name : WAKIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4.45MG BASE
Approval Date : 2019-08-14
Application Number : 211150
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : WAKIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 17.8MG BASE
Approval Date : 2019-08-14
Application Number : 211150
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info : Prescription
Registration Country : Canada
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
Regulatory Info : Prescription
Registration Country : Canada
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
Global Sales Information
Market Place
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03 Oct 2019
Patents & EXCLUSIVITIES
Patent Expiration Date : 2026-02-06
US Patent Number : 8354430
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1101
Delist Requested :
Patent Use Description : METHOD OF TREATING EXC...
Patent Expiration Date : 2026-02-06
Patent Expiration Date : 2029-09-26
US Patent Number : 8486947
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1102
Delist Requested :
Patent Use Description : METHOD OF TREATING CAT...
Patent Expiration Date : 2029-09-26
Patent Expiration Date : 2029-09-26
US Patent Number : 8486947
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1102
Delist Requested :
Patent Use Description : METHOD OF TREATING CAT...
Patent Expiration Date : 2029-09-26
Patent Expiration Date : 2026-02-06
US Patent Number : 8354430
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1102
Delist Requested :
Patent Use Description : METHOD OF TREATING CAT...
Patent Expiration Date : 2026-02-06
Patent Expiration Date : 2026-02-06
US Patent Number : 8354430
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1101
Delist Requested :
Patent Use Description : METHOD OF TREATING EXC...
Patent Expiration Date : 2026-02-06
Patent Expiration Date : 2026-02-06
US Patent Number : 8354430
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1102
Delist Requested :
Patent Use Description : METHOD OF TREATING CAT...
Patent Expiration Date : 2026-02-06
Patent Expiration Date : 2029-09-26
US Patent Number : 8486947
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1101
Delist Requested :
Patent Use Description : METHOD OF TREATING EXC...
Patent Expiration Date : 2029-09-26
Patent Expiration Date : 2029-09-26
US Patent Number : 8486947
Drug Substance Claim :
Drug Product Claim :
Application Number : 211150
Patent Use Code : U-1101
Delist Requested :
Patent Use Description : METHOD OF TREATING EXC...
Patent Expiration Date : 2029-09-26
Exclusivity Code : NCE
Exclusivity Expiration Date : 2024-08-14
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-255
Exclusivity Expiration Date : 2026-08-14
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-331
Exclusivity Expiration Date : 2027-10-13
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-21
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-489
Exclusivity Expiration Date : 2031-06-21
Application Number : 211150
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2024-08-14
Application Number : 211150
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-255
Exclusivity Expiration Date : 2026-08-14
Application Number : 211150
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-331
Exclusivity Expiration Date : 2027-10-13
Application Number : 211150
Product Number : 2
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-21
Application Number : 211150
Product Number : 2
Exclusivity Details :
Exclusivity Code : ODE-489
Exclusivity Expiration Date : 2031-06-21
Application Number : 211150
Product Number : 2
Exclusivity Details :
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