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Desmopressin Acetate

Desmopressin Acetate

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

32 API Suppliers, 21 USDMF, 14 CEP/COS, 2 JDMF, 5 EU WC, 9 KDMF, 22 NDC API, 15 Listed Suppliers

DEVELOPMENTS

3 Drug(s) in Development

3 Drug(s) in Development

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API Reference Price, API Exports, API Imports, FDF Imports

DOSSIERs // Finished Dosage Formulations

173 Dossiers, 53 FDA Orange Book, 82 Europe, 10 Canada, 8 Australia, 7 South Africa, 13 Listed Dossiers

DRUG PRODUCT COMPOSITION

SOLUTION;NASAL - 0.01%, SPRAY, METERED;NASAL - 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 0.004MG/ML, TABLET;ORAL - 0.1MG, TABLET;ORAL - 0.2MG, SPRAY, METERED;NASAL - 0.00083MG/SPRAY, SPRAY, METERED;NASAL - 0.00166MG/SPRAY, SPRAY, METERED;NASAL - 0.15MG/SPRAY, SPRAY, METERED;NASAL - 0.01MG/SPRAY, TABLET;SUBLINGUAL - 0.0277MG, TABLET;SUBLINGUAL - 0.0553MG

SOLUTION;NASAL - 0.01%
SPRAY, METERED;NASAL - 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 0.004MG/ML
TABLET;ORAL - 0.1MG
TABLET;ORAL - 0.2MG
SPRAY, METERED;NASAL - 0.00083MG/SPRAY
SPRAY, METERED;NASAL - 0.00166MG/SPRAY
SPRAY, METERED;NASAL - 0.15MG/SPRAY
SPRAY, METERED;NASAL - 0.01MG/SPRAY
TABLET;SUBLINGUAL - 0.0277MG
TABLET;SUBLINGUAL - 0.0553MG

RELATED EXCIPIENT COMPANIES

Suppliers, 18 Kerry, 15 BASF, 10 Microlex e.U, 7 Gangwal Chemicals, 7 Roquette, 7 Boai NKY Pharmaceuticals Ltd, 7 Actylis, 5 Seppic, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 Gangwal Healthcare, 4 Sigachi Industries, 3 Nanjing Well Pharmaceutical, 3 SPI Pharma, 3 Ulanqab Kema New Material, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Ingredion Pharma Solutions, 2 DFE Pharma, 2 Pharmatrans-Sanaq, 1 Prachin Chemical, 1 Alcedo Pharmachem, 1 Vasa Pharmachem, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Finar, 1 Aeon Procare, 1 DKSH

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 23 Direct Compression, 21 Disintegrants & Superdisintegrants, 18 Solubilizers, 14 Granulation, 13 Lubricants & Glidants, 10 Parenteral, 9 Co-Processed Excipients, 9 Controlled & Modified Release, 7 Chewable & Orodispersible Aids, 6 Thickeners and Stabilizers, 4 Taste Masking, 4 Topical, 4 Emulsifying Agents, 4 Coating Systems & Additives, 3 Film Formers & Plasticizers, 3 Surfactant & Foaming Agents, 2 API Stability Enhancers

GLOBAL SALES INFORMATION

46 US Medicaid Prescriptions, 71 Finished Drug Prices

MARKET PLACE

8 APIs, 8 DOSSIERS // FDF

PATENTS

11 US Patents, 18 Health Canada Patents

ANALYTICAL SOLUTION(s)

2 EDQM Standards, 1 USP Standards, 3 Other Ref. Standards

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow, 28 News

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API REF. PRICE (USD / KG)

292,622

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INTERMEDIATES

DOSSIERS // FDF

USA (Orange Book)

Europe

Canada

Australia

South Africa

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GLOBAL SALES (USD Million)

U.S. Medicaid

172.00

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EXCIPIENTS

115

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USFDA Orange Book Patents

USFDA Exclusivities

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Blog #PharmaFlow

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REF STANDARD

EDQM

USP

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SERVICES

Also known as: Octostim, Minirin, Ddavp, Stimate, Concentraid, Desmopressin acetate anhydrous

Molecular Formula

C₄₈H₆₈N₁₄O₁₄S₂

Molecular Weight

1129.3 g/mol

InChI Key

MLSVJHOYXJGGTR-IFHOVBQLSA-N

FDA UNII

1K12647SFC

A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR.

1 2D Structure

Desmopressin Acetate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

acetic acid;(2S)-N-[(2R)-1-[(2-amino-2-oxoethyl)amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]-1-[(4R,7S,10S,13S,16S)-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carbonyl]pyrrolidine-2-carboxamide

2.1.2 InChI

InChI=1S/C46H64N14O12S2.C2H4O2/c47-35(62)15-14-29-40(67)58-32(22-36(48)63)43(70)59-33(45(72)60-18-5-9-34(60)44(71)56-28(8-4-17-52-46(50)51)39(66)53-23-37(49)64)24-74-73-19-16-38(65)54-30(21-26-10-12-27(61)13-11-26)41(68)57-31(42(69)55-29)20-25-6-2-1-3-7-25;1-2(3)4/h1-3,6-7,10-13,28-34,61H,4-5,8-9,14-24H2,(H2,47,62)(H2,48,63)(H2,49,64)(H,53,66)(H,54,65)(H,55,69)(H,56,71)(H,57,68)(H,58,67)(H,59,70)(H4,50,51,52);1H3,(H,3,4)/t28-,29+,30+,31+,32+,33+,34+;/m1./s1

2.1.3 InChI Key

MLSVJHOYXJGGTR-IFHOVBQLSA-N

2.1.4 Canonical SMILES

CC(=O)O.C1CC(N(C1)C(=O)C2CSSCCC(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)N2)CC(=O)N)CCC(=O)N)CC3=CC=CC=C3)CC4=CC=C(C=C4)O)C(=O)NC(CCCN=C(N)N)C(=O)NCC(=O)N

2.1.5 Isomeric SMILES

CC(=O)O.C1C[C@H](N(C1)C(=O)[C@@H]2CSSCCC(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N2)CC(=O)N)CCC(=O)N)CC3=CC=CC=C3)CC4=CC=C(C=C4)O)C(=O)N[C@H](CCCN=C(N)N)C(=O)NCC(=O)N

2.2 Other Identifiers

2.2.1 UNII

1K12647SFC

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-deamino-8-d-arginine Vasopressin

2. 1-desamino-8-arginine Vasopressin

3. Acetate, Desmopressin

4. Adiuretin

5. Adiuretin Sd

6. Apo-desmopressin

7. Arginine Vasopressin, Deamino

8. Ddavp

9. Deamino Arginine Vasopressin

10. Desmogalen

11. Desmopressin

12. Desmopressin Monoacetate

13. Desmopressin Monoacetate, Trihydrate

14. Desmopressine Ferring

15. Desmospray

16. Desmotabs

17. Ferring, Desmopressine

18. Minirin

19. Minurin

20. Monoacetate, Desmopressin

21. Monoacetate, Trihydrate Desmopressin

22. Nocutil

23. Octim

24. Octostim

25. Trihydrate Desmopressin Monoacetate

26. Vasopressin, 1-deamino-8-d-arginine

27. Vasopressin, 1-desamino-8-arginine

28. Vasopressin, Deamino Arginine

2.3.2 Depositor-Supplied Synonyms

1. Octostim

2. Minirin

3. Ddavp

4. Stimate

5. Concentraid

6. Desmopressin Acetate Anhydrous

7. Noctiva

8. 62288-83-9

9. Ddavp (needs No Refrigeration)

10. Desmospray

11. Anhydrous Desmopressin Acetate

12. Desmopressin Acetate Preservative Free

13. Desmopressin Acetate (needs No Refrigeration)

14. 1k12647sfc

15. Desmopressin Acetate Hydrate

16. Desmotabs

17. Minirine

18. Nocutil

19. Octim

20. Desmopressin Acetate Trihydrate

21. Demopressin Acetate

22. Ddavp Nasal Spray

23. Ddavp Rhinal Tube

24. Stimate Nasal Spray

25. Noqdirna

26. Presinex

27. Desmomelt

28. Unii-1k12647sfc

29. Desmopressin Acetate [usan:jan]

30. Chembl1200556

31. Dtxsid4046864

32. 16679-58-6(free Base)

33. Desmopressin Acetate [mi]

34. Stimate (needs No Refrigeration)

35. Ex-a4285

36. 1-(3-mercaptopropionic Acid)-8-d-arginine Vasopression Monoacetate

37. Bdbm50247923

38. Mfcd00133962

39. Akos025311518

40. Ccg-270644

41. Desmopressin Monoacetate Anhydrous

42. Anhydrous Desmopressin Acetate [mart.]

43. (deamino-cys1,d-arg8)-vasopressin Acetate

44. 789d983

45. Q27252517

46. 1-(3-mercaptopropionic Acid)-8-d-arginine-vasopressin Monoacetate (salt)

47. Vasopressin, 1-(3-mercaptopropanoic Acid)-8-d-arginine-, Monoacetate (salt)

48. Vasopressin,1-(3-mercaptopropanoic Acid)-8-d-arginine-,monoacetate(salt)(9ci)

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₄₈H₆₈N₁₄O₁₄S₂
Molecular Weight	1129.3 g/mol
Hydrogen Bond Donor Count	14
Hydrogen Bond Acceptor Count	17
Rotatable Bond Count	19
Exact Mass	1128.44808525 g/mol
Monoisotopic Mass	1128.44808525 g/mol
Topological Polar Surface Area	526 Å²
Heavy Atom Count	78
Formal Charge	0
Complexity	2070
Isotope Atom Count	0
Defined Atom Stereocenter Count	7
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Desmopressin acetate
Drug Label	Desmopressin Nasal Spray Solution USP, 0.01% is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is:Mol. w...
Active Ingredient	Desmopressin acetate
Dosage Form	Injectable; Spray, metered; Tablet; Solution
Route	Nasal; oral; Injection; Oral
Strength	0.01mg/spray; 0.004mg/ml; 0.2mg; 0.01%; 0.1mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Glenmark Generics; Teva Pharms; Hospira; Actavis Labs Fl; Apotex; Bausch And Lomb; Sun Pharm Inds; Teva Pharms Usa; Ferring

2 of 2
Drug Name	Desmopressin acetate
Drug Label	Desmopressin Nasal Spray Solution USP, 0.01% is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is:Mol. w...
Active Ingredient	Desmopressin acetate
Dosage Form	Injectable; Spray, metered; Tablet; Solution
Route	Nasal; oral; Injection; Oral
Strength	0.01mg/spray; 0.004mg/ml; 0.2mg; 0.01%; 0.1mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Glenmark Generics; Teva Pharms; Hospira; Actavis Labs Fl; Apotex; Bausch And Lomb; Sun Pharm Inds; Teva Pharms Usa; Ferring

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antidiuretic Agents

Agents that reduce the excretion of URINE, most notably the octapeptide VASOPRESSINS. (See all compounds classified as Antidiuretic Agents.)

Hemostatics

Agents acting to arrest the flow of blood. Absorbable hemostatics arrest bleeding either by the formation of an artificial clot or by providing a mechanical matrix that facilitates clotting when applied directly to the bleeding surface. These agents function more at the capillary level and are not effective at stemming arterial or venous bleeding under any significant intravascular pressure. (See all compounds classified as Hemostatics.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Increased Coagulation Factor VIII Activity [PE]; Increased Coagulation Factor VIII Concentration [PE]; Vasopressin Analog [EPC]; Vasopressins [CS]; Factor VIII Activator [EPC]

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