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ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 8 USDMF, 6 CEP/COS, 4 JDMF, 2 EU WC, 4 NDC API, 13 Listed Suppliers, $ API Reference Price

22 API Suppliers
8 USDMF
6 CEP/COS
4 JDMF
2 EU WC
4 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

120 FDF Dossiers, 32 FDA Orange Book, 61 Europe, 14 Canada, 4 South Africa, 9 Listed Dossiers

120 FDF Dossiers
32 FDA Orange Book
61 Europe
14 Canada
4 South Africa
9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG

drugProductComposition
TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 10 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
10 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 51 Finished Drug Prices, 3 Annual Reports

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7 US Medicaid Prescriptions
51 Finished Drug Prices
3 Annual Reports

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5 APIs, 1 FDF Dossiers

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5 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM , 5 USP , 5 Others

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5 USP
5 Others

Aspen Desogestrel

Synopsis

ACTIVE PHARMA INGREDIENTS

22

API Suppliers

8

USDMF

6

CEP/COS

CEP/COS Certifications

4

JDMF

2

EU WC

0

KDMF

4

NDC API

0

VMF

13

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 62,578

MARKET PLACE

5

API

1

FDF

4INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

120

FDF Dossiers

32

FDA Orange Book

FDA (Orange Book)

61

Europe

14

Canada

0

Australia

4

South Africa

9

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

2

EDQM

5

USP

0

JP

5

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

1

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

10

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

281,031

Annual Reports (USD Million)

314

Finished Drug Prices

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0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 54024-22-5, Cerazette, Desogen, Desogestrelum, Org-2969, Mircette

Molecular Formula

C₂₂H₃₀O

Molecular Weight

310.5 g/mol

InChI Key

RPLCPCMSCLEKRS-BPIQYHPVSA-N

FDA UNII

81K9V7M3A3

Desogestrel

A synthetic progestational hormone used often as the progestogenic component of combined oral contraceptive agents (ORAL CONTRACEPTIVES, COMBINED).

Desogestrel is a Progestin.

1 2D Structure

Desogestrel

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(8S,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-11-methylidene-1,2,3,6,7,8,9,10,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol

2.1.2 InChI

InChI=1S/C22H30O/c1-4-21-14-15(3)20-17-9-7-6-8-16(17)10-11-18(20)19(21)12-13-22(21,23)5-2/h2,8,17-20,23H,3-4,6-7,9-14H2,1H3/t17-,18-,19-,20+,21-,22-/m0/s1

2.1.3 InChI Key

RPLCPCMSCLEKRS-BPIQYHPVSA-N

2.1.4 Canonical SMILES

CCC12CC(=C)C3C(C1CCC2(C#C)O)CCC4=CCCCC34

2.1.5 Isomeric SMILES

CC[C@]12CC(=C)[C@H]3[C@H]([C@@H]1CC[C@]2(C#C)O)CCC4=CCCC[C@H]34

2.2 Other Identifiers

2.2.1 UNII

81K9V7M3A3

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 13 Ethyl 11 Methylene 18,19 Dinor 17 Alpha Pregn 4 En 20 Yn 17 Ol

2. 13-ethyl-11-methylene-18,19-dinor-17 Alpha-pregn-4-en-20-yn-17-ol

3. 18,19-dinorpregn-4-en-20-yn-17-ol, 13-ethyl-11-methylene-, (17alpha)-

4. Alpha-pregn-4-en-20-yn-17-ol, 13-ethyl-11-methylene-18,19-dinor-17

5. Cerazette

6. Marvelon

7. Org 2969

8. Org-2969

9. Org2969

2.3.2 Depositor-Supplied Synonyms

1. 54024-22-5

2. Cerazette

3. Desogen

4. Desogestrelum

5. Org-2969

6. Mircette

7. Org 2969

8. Desogestrelum [inn-latin]

9. 13-ethyl-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-17-ol

10. (8s,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-11-methylidene-1,2,3,6,7,8,9,10,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol

11. Chebi:4453

12. 81k9v7m3a3

13. Ncgc00167449-01

14. 13-ethyl-11-methylene-18,19-dinorpregn-4-en-20-yn-17alpha-ol

15. Hsdb 3593

16. Sr-01000883959

17. Einecs 258-929-4

18. Desogestrel (usan/inn)

19. Unii-81k9v7m3a3

20. Desogestrel [usan:inn:ban]

21. 18,19-dinorpregn-4-en-20-yn-17-ol, 13-ethyl-11-methylene-, (17.alpha.)-

22. Mfcd00869346

23. Desogestrel [mi]

24. Desogestrel [inn]

25. Desogestrel [jan]

26. Dsstox_cid_2898

27. Desogestrel [hsdb]

28. Desogestrel [usan]

29. 18,19-dinorpregn-4-en-20-yn-17-ol, 13-ethyl-11-methylene-, (17alpha)-

30. Desogestrel [vandf]

31. Chembl1533

32. Desogestrel [mart.]

33. Dsstox_rid_76779

34. Dsstox_gsid_22898

35. Schembl41341

36. Desogestrel [usp-rs]

37. Desogestrel [who-dd]

38. Gtpl7065

39. Dtxsid6022898

40. Desogestrel [orange Book]

41. 17alpha-ethynyl-11-methylidene-18a-homo-estr-4-en-17beta-ol

42. Desogestrel [ep Monograph]

43. Desogestrel [usp Monograph]

44. Kariva Component Desogestrel

45. Volnea Component Desogestrel

46. Bcp18794

47. Bekyree Component Desogestrel

48. Desogen Component Desogestrel

49. Enskyce Component Desogestrel

50. Pimtrea Component Desogestrel

51. Velivet Component Desogestrel

52. Viorele Component Desogestrel

53. Zinc4097416

54. Tox21_112453

55. 13-ethyl-11-methylene-18,19-dinor-17a-pregn-4-en-20-yn-17-ol

56. Ac-308

57. Bdbm50423510

58. Cyclessa Component Desogestrel

59. Isibloom Component Desogestrel

60. Lmst02030104

61. Mircette Component Desogestrel

62. S4638

63. (17alpha)-13-ethyl-11-methylene-18,19-dinorpregn-4-en-20-yn-17-ol

64. Akos015963198

65. Desogestrel Component Of Kariva

66. Ccg-267585

67. Cs-3686

68. Db00304

69. Desogestrel Component Of Desogen

70. Desogestrel Component Of Velivet

71. Ortho-cept Component Desogestrel

72. Desogestrel Component Of Cyclessa

73. Desogestrel Component Of Mircette

74. As-13022

75. Hy-12516

76. Desogestrel 100 Microg/ml In Acetonitrile

77. Desogestrel Component Of Ortho-cept

78. Cas-54024-22-5

79. B4976

80. D4163

81. C07629

82. C15951

83. D02367

84. Desogestrel, Vetranal(tm), Analytical Standard

85. 024d225

86. Q415304

87. J-520217

88. Sr-01000883959-1

89. Sr-01000883959-2

90. 17alpha-ethynyl-13beta-ethyl-11-methylene-4-gonen-17-ol

91. Desogestrel, British Pharmacopoeia (bp) Reference Standard

92. Desogestrel, European Pharmacopoeia (ep) Reference Standard

93. Desogestrel, United States Pharmacopeia (usp) Reference Standard

94. Desogestrel, Pharmaceutical Secondary Standard; Certified Reference Material

95. Desogestrel For System Suitability, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₃₀O
Molecular Weight	310.5 g/mol
XLogP3	4.9
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	2
Exact Mass	310.229665576 g/mol
Monoisotopic Mass	310.229665576 g/mol
Topological Polar Surface Area	20.2 Å²
Heavy Atom Count	23
Formal Charge	0
Complexity	605
Isotope Atom Count	0
Defined Atom Stereocenter Count	6
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Desogen
Active Ingredient	Desogestrel; ethinyl estradiol
Dosage Form	Tablet
Route	Oral-28
Strength	0.03mg; 0.15mg
Market Status	Prescription
Company	Organon Usa

2 of 2
Drug Name	Desogen
Active Ingredient	Desogestrel; ethinyl estradiol
Dosage Form	Tablet
Route	Oral-28
Strength	0.03mg; 0.15mg
Market Status	Prescription
Company	Organon Usa

4.2 Therapeutic Uses

Contraceptives, Oral, Synthetic; Progestational Hormones, Synthetic

National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)

Apri (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841

Cerazette /is indicated for/ contraception.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/

Desogestrel is an synthetic progestogen structurally related to levonorgestrel, with actions and uses similar to those of progestogens in general. It is reported to have potent progestogenic activity and little or no androgenic activity. It is used as the progestogenic component of combined mono- and multiphasic oral contraceptive preparations and as a subdermal implantable 'progestogen-only' contraceptive.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V72 587 (1999)

4.3 Drug Warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841

Oral contraceptives like Apri (desogestrel and ethinyl estradiol) tablets should not be used in women who currently have the following conditions: thrombophlebitis or thromboembolic disorders; a past history of deep vein thrombophlebitis or thromboembolic disorders; cerebral vascular or coronary artery disease; known or suspected carcinoma of the breast; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice with prior pill use; hepatic adenomas or carcinomas...

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841

Cerazette does not influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However, small amounts of etonogestrel are excreted in the breast milk. As a result, 0.01 - 0.05 ug etonogestrel per kg body weight per day may be ingested by the child (based on an estimated milk ingestion of 150 mL/kg/day).

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/

Epidemiological investigations have associated the use of combined oral contraceptives (COC) with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an estrogenic component is unknown, Cerazette should be discontinued in the event of a thrombosis. Discontinuation of Cerazette should also be considered in case of long-term immobilization due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/

For more Drug Warnings (Complete) data for DESOGESTREL (48 total), please visit the HSDB record page.

4.4 Drug Indication

Oral desogestrel is used in combination with [ethinylestradiol] as a contraceptive agent for the prevention of pregnancy. Desogestrel is part of the combined oral contraceptives that contain a mix of estrogen and progestin which inhibit ovulation.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

The effects of desogestrel are divided on reproductive including modification of luteinizing hormone and follicle stimulating hormone, declines on the onset of menstruation, and increases the viscosity of the vaginal fluid; and on metabolic that includes increase insulin secretion and resistance, increased lipase activity, and increased fat deposition. The effect of desogestrel on the lipids has been studied extensively and the results are contradictory. Desogestrel main therapeutic effect due to its mechanism of action is known to be related to the inhibition of the ovulation in 97% of the cycles. This effect was proven in clinical trials in non-breastfeeding women from which the Pearl failure rate was reported to be of 0.17 per 100 women-years. This result indicated that desogestrel is more efficient when compared to other progestogen-only pills. All the therapeutic effect is produced by a transformation of the endometrium followed by an inhibition of the ovulation due to the suppression of other hormones. Desogestrel has been widely confirmed to be related to an increase in the risk of venous thromboembolism due to the driven increased in blood coagulation factors, leading to a pronounced prothrombotic state. However, the effects of desogestrel are known to not impact significantly the level of total cholesterol remaining in the range of change of 10% which allows it to be a molecule that presents a favorable lipid profile.

5.2 MeSH Pharmacological Classification

Contraceptives, Oral, Hormonal

Oral contraceptives which owe their effectiveness to hormonal preparations. (See all compounds classified as Contraceptives, Oral, Hormonal.)

Progestins

Compounds that interact with PROGESTERONE RECEPTORS in target tissues to bring about the effects similar to those of PROGESTERONE. Primary actions of progestins, including natural and synthetic steroids, are on the UTERUS and the MAMMARY GLAND in preparation for and in maintenance of PREGNANCY. (See all compounds classified as Progestins.)

Contraceptives, Oral, Synthetic

Oral contraceptives which owe their effectiveness to synthetic preparations. (See all compounds classified as Contraceptives, Oral, Synthetic.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

DESOGESTREL

5.3.2 FDA UNII

81K9V7M3A3

5.3.3 Pharmacological Classes

Established Pharmacologic Class [EPC] - Progestin

5.4 ATC Code

G03AC09

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

G - Genito urinary system and sex hormones

G03 - Sex hormones and modulators of the genital system

G03A - Hormonal contraceptives for systemic use

G03AC - Progestogens

G03AC09 - Desogestrel

5.5 Absorption, Distribution and Excretion

Absorption

After oral administration, desogestrel is rapidly absorbed and it reaches a peak concentration of 2 ng/ml after 1.5 hours. The bioavailability of desogestrel is reported to be in the range of 60-80% and the reported AUC is of 3000 ng.h/ml. Almost all the administered dose is modified to the active metabolite, [etonogestrel].

Route of Elimination

The elimination of desogestrel is found to be mainly renal corresponding to about 6 times the dose eliminated in the bile. The elimination of desogestrel is only done as the metabolites and not as the unchanged drug and about 85% of the administered dose can be excreted as metabolites after 6-8 days.

Volume of Distribution

The apparent volume of distribution of desogestrel is of 1.5 L/kg.

Clearance

The metabolic clearance rate of desogestrel is reported to be of about 2 ml/min/kg.

After oral dosing of Cerazette desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately 70%.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/

In the third cycle of use after a single desogestrel and ethinyl estradiol tablet, maximum concentrations of 3-keto-desogestrel of 2,805 +/- 1,203 pg/mL (mean+/-SD) are reached at 1.4+/-0.8 hours. The area under the curve (AUC) is 33,858+/-11,043 pg/mL (hr) after a single dose.

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841

At steady state, attained from at least day 19 onwards, maximum concentrations of 5,840 +/-1,667 pg/mL are reached at 1.4+/-0.9 hours. The minimum plasma levels of 3-keto-desogestrel at steady state are 1,400+/-560 pg/mL. The AUC0-24 at steady state is 52,299+/-17,878 pg/mL (hr). The mean AUC0 for 3-keto-desogestrel at single dose is significantly lower than the mean AUC0-24 at steady state. This indicates that the kinetics of 3-keto-desogestrel are non-linear due to an increase in binding of 3-keto-desogestrel to sex hormone-binding globulin in the cycle, attributed to increased sex hormone-binding globulin levels which are induced by the daily administration of ethinyl estradiol. Sex hormone-binding globulin levels increased significantly in the third treatment cycle from day 1 (150+/-64 nmol/L) to day 21 (230+/-59 nmol/L).

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841

Etonogestrel is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser extent to sex hormone-binding globulin (SHBG).

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/

For more Absorption, Distribution and Excretion (Complete) data for DESOGESTREL (8 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Desogestrel is rapidly metabolized in the intestinal mucosa and by first-pass hepatic metabolism to form the major metabolite of desogestrel is [etonogestrel] which is the biologically active metabolite. This modification is described by the hydroxylation in C3 of the desogestrel molecule. Later, etonogestrel is metabolized following the normal pathways of steroid metabolism. On the other hand, due to the 11-methylene side chain, desogestrel cannot be metabolized to other progestins.

In addition to 3-keto-desogestrel, other phase I metabolites are 3alpha-OH-desogestrel, 3beta-OH-desogestrel, and 3alpha-OH-5alpha-H-desogestrel. These other metabolites are not known to have any pharmacologic effects, and are further converted in part by conjugation (phase II metabolism) into polar metabolites, mainly sulfates and glucuronides.

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841

Desogestrel is metabolized via hydroxylation and dehydrogenation to the active metabolite etonogestrel. Etonogestrel is metabolised via sulphate and glucuronide conjugation.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/

Desogestrel is metabolized rapidly and completely in the liver and gut wall. It is metabolized to 3-keto-desogestrel, which mediates its progestogenic effects, and it is not metabolized further to another progestogen. The serum concentrations of 3-keto-desogestrel reached maximum levels within 2-3 hours after oral administration of desogestrel and were subsequently cleared with a half-life of 12-24 hours.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V72 227 (1999)

The metabolism of desogestrel in microsomes from six hours livers in vitro /were studied/. The main metabolite formed was 3-keto-desogestrel; 3alpha-hydroxydesogestrel and 3beta-hydroxydesogestrel were also detected. The metabolism of desogestrel was inhibited by 50% by primaquine at a concentration of 30 umol/L, but not by levonorgestrel at 250 umol/L.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V72 227 (1999)

For more Metabolism/Metabolites (Complete) data for DESOGESTREL (7 total), please visit the HSDB record page.

Desogestrel has known human metabolites that include 3-alpha-hydroxydesogestrel, 3-beta-hydroxy-desogestrel, and Desogestrel 17-O-glucuronide.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

5.7 Biological Half-Life

The terminal half-life of desogestrel is determined to be of 30 hours.

Etonogestrel is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple dosing.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/

The elimination half-life for 3-keto-desogestrel is approximately 38+/-20 hours at steady state. /3-Keto-desogestrel/

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841

5.8 Mechanism of Action

Desogestrel enters the cell passively and acts by binding selectively to the progesterone receptor and generating low androgenic activity. Its binding produces an effect like a transcription factor and thus, it produces modifications in the mRNA synthesis. The active metabolite of desogestrel, [etonogestrel], presents a combination of high progestational activity with minimal intrinsic androgenicity.

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus, which increase the difficulty of sperm entry into the uterus, and changes in the endometrium which reduce the likelihood of implantation. Receptor binding studies, as well as studies in animals, have shown that 3-keto-desogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with minimal intrinsic androgenicity. The relevance of this latter finding in humans is unknown.

US Natl Inst Health; DailyMed. Current Medication Information APRI (desogestrel and ethinyl estradiol) kit (January 2011). Available from, as of March 22, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=37841

In contrast to traditional progestogen-only pills, the contraceptive effect of Cerazette is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus.

Datapharm Communications Ltd; Electronic Medicines Compendium (eMC), Summary of Product Characteristics (SPC) for A Cerazette film-coated tablet (Last updated December 2007). Available from, as of March 23, 2011: https://www.medicines.org.uk/EMC/medicine/10098/SPC/Cerazette+75+microgram+film-coated+tablet/

Recent studies have demonstrated that desogestrel activates the estrogen receptor-alpha at an activity of about 50% of that of 17beta-estradiol but activates the estrogen receptor-beta at an activity of only 20%. Desogestrel and/or its metabolite 3-keto-desogestrel (etonogestrel) were strongly progestogenic (approximately twofold over progesterone), weakly or not androgenic in animal studies in vivo and in-vitro binding assays and weakly or not active on the glucocorticoid receptor. The active metabolite of desogestrel, 3-ketodesogestrel, strongly bound to and activated progesterone receptor-A and, to a slightly lesser extent, progesterone receptor-B

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V91 163 (2007)

Improvement in oral contraceptive formulations was originally achieved through dose reduction of the estrogen and progestogen components. Recently, further improvement was achieved by increasing the selectivity of contraceptive progestins. The ratio between the affinity for the progesterone receptor and the affinity for the androgen receptor is an indicator of progesterone (or androgen) selectivity of a progestin. This ratio (selectivity index) reflects the relative amount of androgenic or progestational effect at a given dose. Relative selectivity can be characterized with in vitro receptor-binding studies and animal pharmacologic experiments. In comparison with levonorgestrel, desogestrel displays markedly lower androgenicity and slightly increased relative progestational activity. In receptor-binding experiments and animal pharmacologic studies, 3-keto-desogestrel, the active metabolite of desogestrel, shows the highest selectivity index. The favorable effect of desogestrel-containing oral contraceptives on lipoprotein metabolism and preexisting androgen-dependent skin disorders and the absence of adverse effects on blood pressure and body weight are attributed to the increased progestin selectivity of desogestrel.

PMID:8447353 Collins D; Am J Obstet Gynecol 168 (3 Pt 2): 1010-6 (1993)

For more Mechanism of Action (Complete) data for DESOGESTREL (6 total), please visit the HSDB record page.

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USDMF

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Aspen Oss Bv

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Desogestrel

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-13

Pay. Date : 2013-08-01

DMF Number : 7197

Submission : 1987-10-28

Status : Active

Type : II

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Symbiotec Pharmalab Private Ltd

India

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Desogestrel Ep/bp, Micronized

GDUFA

DMF Review : N/A

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DMF Number : 28124

Submission : 2014-03-17

Status : Active

Type : II

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Curia Italy Srl

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Gedeon Richter Plc

Hungary

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Industriale Chimica Srl

Italy

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Lupin Ltd

India

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Organon Nv

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ASPEN OSS B.V. Oss NL

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Desogestrel

Certificate Number : R1-CEP 2009-300 - Rev 00

Status : Valid

Issue Date : 2016-03-16

Type : Chemical

Substance Number : 1717

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CURIA SPAIN S.A.U. Boecillo ES

U.S.A

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GEDEON RICHTER PLC Budapest HU

Hungary

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Industriale Chimica S.R.L. Saronno ...

Italy

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LIBBS FARMACEUTICA LTDA. Embu das A...

Brazil

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Desogestrel

Registration Number : 303MF10070

Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands

Initial Date of Registration : 2021-04-22

Latest Date of Registration : 2021-04-22

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INDUSTRIALE CHIMICA s. r. l.

Italy

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Desogestrel (BP/ Ph.Eur)

Date of Issue : 2022-08-31

Valid Till : 2025-07-02

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Desogestrel BP/EP

Date of Issue : 2022-07-05

Valid Till : 2025-07-02

Written Confirmation Number : WC-0161A2

Address of the Firm : 385/2, Pigdamber, Rau, Indore-453 331, MP, India

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DESOGESTREL

NDC Package Code : 60870-0460

Start Marketing Date : 1999-08-02

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Italy

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About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...

Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen API works tirelessly to deliver top-quality APIs to clients worldwide. Aspen API has a portfolio of over 58 high-quality APIs, including high potency, oncology, peptides, narcotics, analgesics, botanical extractions, and biochemicals. Aspen API places a strong emphasis on sustainability. It employs eco-friendly technologies and solvents in its chemical processes, ensuring responsible and environmentally conscious manufacturing.

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About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...

Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable operations, and innovation has driven their commitment to improving global healthcare access. With a state-of-the-art manufacturing facility inaugurated in 2004, Symbiotec has become a trusted provider in the industry. Their certifications including WHO-GMP, ISO, US FDA, and EU GMP showcase their dedication to quality and excellence. Over two decades, they've maintained their position through adaptability, efficiency, and competitive pricing.

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL-21 - 0.15MG;0.03MG **Fed...DOSAGE - TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20301

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USFDA APPLICATION NUMBER - 21090

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