List of Drug Master Files (DMF) of Pitolisant Hydrochloride Active Pharmaceutical Ingredient listed on PharmaCompass.com

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Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

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Chemistry

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Also known as: 903576-44-3, Ciproxidine, Bf 2649, Pitolisant hcl, Pitolisant (hydrochloride), Bf 2649 hydrochloride
Molecular Formula
C17H27Cl2NO
Molecular Weight
332.3  g/mol
InChI Key
XLFKECRRMPOAQS-UHFFFAOYSA-N
FDA UNII
YV33CH63HI

Pitolisant Hydrochloride
1 2D Structure

Pitolisant Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[3-[3-(4-chlorophenyl)propoxy]propyl]piperidine;hydrochloride
2.1.2 InChI
InChI=1S/C17H26ClNO.ClH/c18-17-9-7-16(8-10-17)6-4-14-20-15-5-13-19-11-2-1-3-12-19;/h7-10H,1-6,11-15H2;1H
2.1.3 InChI Key
XLFKECRRMPOAQS-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CCN(CC1)CCCOCCCC2=CC=C(C=C2)Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
YV33CH63HI
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

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)

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 332.3 g/mol
Molecular Formula C17H27Cl2NO
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count8
Exact Mass331.1469699 g/mol
Monoisotopic Mass331.1469699 g/mol
Topological Polar Surface Area12.5 Ų
Heavy Atom Count21
Formal Charge0
Complexity235
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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01

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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02

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Nuray Chemicals

03

Biophore India Pharmaceuticals Pvt...

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Biophore

04

Sigmak Lifesciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSigmak Lifesciences: Empowering Business with High-quality Ingredients.

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Sigmak Lifesciences

05

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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06

Dasami Lab

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

ASC 2024
Not Confirmed
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Dasami Lab

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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MSN Laboratories

India

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Emmennar Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

ASC 2024
Not Confirmed
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Emmennar Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virchow Group

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

ASC 2024
Not Confirmed
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USDMF

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01

  • fda
  • EDQM
  • WHO-GMP

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GDUFA

DMF Review : Complete

Rev. Date : 2023-03-31

Pay. Date : 2023-03-15

DMF Number : 36859

Submission : 2022-03-01

Status : Active

Type : II

Nuray Chemicals

02

  • fda
  • EDQM
  • WHO-GMP

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GDUFA

DMF Review : Complete

Rev. Date : 2023-05-19

Pay. Date : 2023-03-21

DMF Number : 38174

Submission : 2023-03-30

Status : Active

Type : II

Nuray Chemicals

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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GDUFA

DMF Review : Complete

Rev. Date : 2023-07-28

Pay. Date : 2023-07-06

DMF Number : 37753

Submission : 2022-12-31

Status : Active

Type : II

Biophore

04

Luxepack
Not Confirmed

04

Luxepack
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2023-06-22

Pay. Date : 2023-04-21

DMF Number : 38307

Submission : 2023-05-09

Status : Active

Type : II

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05

Luxepack
Not Confirmed

05

Luxepack
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2024-08-22

Pay. Date : 2024-07-25

DMF Number : 39126

Submission : 2023-12-05

Status : Active

Type : II

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06

Luxepack
Not Confirmed

06

Luxepack
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2023-05-17

Pay. Date : 2023-04-25

DMF Number : 38131

Submission : 2023-03-27

Status : Active

Type : II

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EU WC

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Pitolisant Hydrochloride IH

Date of Issue : 2024-02-20

Valid Till : 2026-12-06

Written Confirmation Number : WC-0416

Address of the Firm : Plot No. 111 SIDCO Industrial Estate, Kakkalur Thiruvallur-602003 Tamil Nadu, In...

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Patents & EXCLUSIVITIES

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US Patents

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01

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

US Patent Number : 8207197

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 211150

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-07

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02

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

US Patent Number : 8207197

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 211150

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-07

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03

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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Not Confirmed

PITOLISANT HYDROCHLORIDE

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

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04

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

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

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05

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

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

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06

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

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

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07

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

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

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08

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

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

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09

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ASC 2024
Not Confirmed

HARMONY

U.S.A
arrow
ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

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

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10

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ASC 2024
Not Confirmed

HARMONY

U.S.A
arrow
ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

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

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US Exclusivities

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01

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2024-08-14

Application Number : 211150

Product Number : 1

Exclusivity Details :

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02

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : ODE-255

Exclusivity Expiration Date : 2026-08-14

Application Number : 211150

Product Number : 1

Exclusivity Details :

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03

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : ODE-331

Exclusivity Expiration Date : 2027-10-13

Application Number : 211150

Product Number : 1

Exclusivity Details :

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04

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : NPP

Exclusivity Expiration Date : 2027-06-21

Application Number : 211150

Product Number : 1

Exclusivity Details :

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05

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : ODE-489

Exclusivity Expiration Date : 2031-06-21

Application Number : 211150

Product Number : 1

Exclusivity Details :

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06

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2024-08-14

Application Number : 211150

Product Number : 2

Exclusivity Details :

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07

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ASC 2024
Not Confirmed

HARMONY

U.S.A
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ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : ODE-255

Exclusivity Expiration Date : 2026-08-14

Application Number : 211150

Product Number : 2

Exclusivity Details :

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08

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ASC 2024
Not Confirmed

HARMONY

U.S.A
arrow
ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : ODE-331

Exclusivity Expiration Date : 2027-10-13

Application Number : 211150

Product Number : 2

Exclusivity Details :

blank

09

arrow
ASC 2024
Not Confirmed

HARMONY

U.S.A
arrow
ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : NPP

Exclusivity Expiration Date : 2027-06-21

Application Number : 211150

Product Number : 2

Exclusivity Details :

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10

arrow
ASC 2024
Not Confirmed

HARMONY

U.S.A
arrow
ASC 2024
Not Confirmed

PITOLISANT HYDROCHLORIDE

Exclusivity Code : ODE-489

Exclusivity Expiration Date : 2031-06-21

Application Number : 211150

Product Number : 2

Exclusivity Details :

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ABOUT THIS PAGE

Pitolisant Hydrochloride Manufacturers | Traders | Suppliers

Pitolisant Hydrochloride Manufacturers, Traders, Suppliers 1
56

We have 5 companies offering Pitolisant Hydrochloride

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  1. Biophore India Pharmaceuticals Pvt Ltd
  2. Nuray Chemicals Private Limited
  3. Dasami Lab
  4. Emmennar Pharma
  5. MSN Laboratories
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