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Also known as: Implanon, 54048-10-1, 3-oxodesogestrel, Nexplanon, 3-ketodesogestrel, 3-keto-desogestrel
Molecular Formula
C22H28O2
Molecular Weight
324.5  g/mol
InChI Key
GCKFUYQCUCGESZ-BPIQYHPVSA-N
FDA UNII
304GTH6RNH

Etonogestrel
Etonogestrel is a synthetic form of the naturally occurring female sex hormone progesterone. Etonogestrel binds to the cytoplasmic progesterone receptors in the reproductive system and subsequently activates progesterone receptor mediated gene expression. As a result of the negative feedback mechanism, luteinizing hormone (LH) release is inhibited, which leads to an inhibition of ovulation and an alteration in the cervical mucus and endometrium.
Etonogestrel is a Progestin.
1 2D Structure

Etonogestrel

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(8S,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-11-methylidene-2,6,7,8,9,10,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one
2.1.2 InChI
InChI=1S/C22H28O2/c1-4-21-13-14(3)20-17-9-7-16(23)12-15(17)6-8-18(20)19(21)10-11-22(21,24)5-2/h2,12,17-20,24H,3-4,6-11,13H2,1H3/t17-,18-,19-,20+,21-,22-/m0/s1
2.1.3 InChI Key
GCKFUYQCUCGESZ-BPIQYHPVSA-N
2.1.4 Canonical SMILES
CCC12CC(=C)C3C(C1CCC2(C#C)O)CCC4=CC(=O)CCC34
2.1.5 Isomeric SMILES
CC[C@]12CC(=C)[C@H]3[C@H]([C@@H]1CC[C@]2(C#C)O)CCC4=CC(=O)CC[C@H]34
2.2 Other Identifiers
2.2.1 UNII
304GTH6RNH
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one

2. 18,19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-, (17-alpha)-

3. 3-keto-desogestrel

4. 3-ketodesogestrel

5. 3-oxo Desogestrel

6. 3-oxodesogestrel

7. Implanon

8. Nexplanon

9. Org-3236

2.3.2 Depositor-Supplied Synonyms

1. Implanon

2. 54048-10-1

3. 3-oxodesogestrel

4. Nexplanon

5. 3-ketodesogestrel

6. 3-keto-desogestrel

7. Org-3236

8. Org 3236

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

10. 304gth6rnh

11. Chebi:50777

12. 18,19-dinorpregn-4-en-20-yn-3-one,13-ethyl-17-hydroxy-11-methylene-, (17a)-

13. Etonogestrelum

14. Implanon (tn)

15. Etonogestrel (usan/inn)

16. Unii-304gth6rnh

17. Etonogestrel [usan:inn:ban]

18. Ncgc00168777-01

19. Einecs 258-936-2

20. 17-ethinyl-17-beta-hydroxy-18-methyl-11-methylene-4-estren-3-one

21. Etonogestrel [mi]

22. Etonogestrel [inn]

23. Etonogestrel [usan]

24. 13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one

25. Chembl1531

26. Dsstox_cid_26782

27. Dsstox_rid_81900

28. Etonogestrel [vandf]

29. Dsstox_gsid_46782

30. Desogestrel Impurity D

31. Etonogestrel [mart.]

32. Desogestrel Related Compound C

33. Etonogestrel [usp-rs]

34. Etonogestrel [who-dd]

35. Schembl117703

36. Gtpl7590

37. Dtxsid9046782

38. Etonogestrel (3-ketodesogestrel)

39. Etonogestrel, >=98% (hplc)

40. Etonogestrel [orange Book]

41. Bcp28481

42. Hy-b0652

43. 3-oxodesogestrel;3-keto-desogestrel

44. Tox21_112638

45. Bdbm50423516

46. S4673

47. Zinc11680067

48. Nuvaring Component Etonogestrel

49. 13-ethyl-11-methylene-18,19-dinor-17-alpha-pregn-4-en-20-yn-3-one

50. 17alpha-ethynyl-17beta-hydroxy-11-methylidene-18a-homo-estr-4-en-3-one

51. Ccg-267753

52. Db00294

53. (17-alpha)-13-ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one

54. (17alpha)-13-ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one

55. 18,19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-, (17-alpha)-

56. Etonogestrel Component Of Nuvaring

57. Ncgc00168777-04

58. As-73246

59. Cas-54048-10-1

60. Desogestrel Impurity D [ep Impurity]

61. C75537

62. D04104

63. Desogestrel Related Compound C [usp-rs]

64. 048e101

65. A829925

66. Q3733839

67. Etonogestrel, United States Pharmacopeia (usp) Reference Standard

68. (17-alpha)-13-ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-on

69. 13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17.alpha.-pregn-4-en-20-yn-3-one

70. 18,19-dinor-17alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-

71. Desogestrel Related Compound C, United States Pharmacopeia (usp) Reference Standard

72. (1r,3as,3bs,9ar,9bs,11as)-11a-ethyl-1-ethynyl-1-hydroxy-10-methylidene-1h,2h,3h,3ah,3bh,4h,5h,7h,8h,9h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-one

73. (1s,2r,10s,11s,14r,15s)-15-ethyl-14-ethynyl-14-hydroxy-17-methylidenetetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one

74. (8s,9s,13s,14s,17r)-13-ethyl-17-ethynyl-17-hydroxy-11-methylene-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-3(2h)-one

75. 13-ethyl-17-hydroxy-11-methylidene-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one (3-ketodesogestrel)

76. 18,19-dinor-17.alpha.-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-

2.4 Create Date
2006-07-28
3 Chemical and Physical Properties
Molecular Weight 324.5 g/mol
Molecular Formula C22H28O2
XLogP33.3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count2
Exact Mass324.208930132 g/mol
Monoisotopic Mass324.208930132 g/mol
Topological Polar Surface Area37.3 Ų
Heavy Atom Count24
Formal Charge0
Complexity677
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameImplanon
PubMed HealthEtonogestrel (Implantation)
Drug ClassesContraceptive, Progestin
Drug LabelIMPLANON (etonogestrel implant) is a progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 22). Each...
Active IngredientEtonogestrel
Dosage FormImplant
RouteImplantation
Strength68mg/implant
Market StatusPrescription
CompanyOrganon Usa

2 of 4  
Drug NameNexplanon
PubMed HealthEtonogestrel (Implantation)
Drug ClassesContraceptive, Progestin
Drug LabelNEXPLANON is a radiopaque, progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is white/off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 18). Each impl...
Active IngredientEtonogestrel
Dosage FormImplant
RouteImplantation
Strength68mg/implant
Market StatusPrescription
CompanyOrganon Usa

3 of 4  
Drug NameImplanon
PubMed HealthEtonogestrel (Implantation)
Drug ClassesContraceptive, Progestin
Drug LabelIMPLANON (etonogestrel implant) is a progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 22). Each...
Active IngredientEtonogestrel
Dosage FormImplant
RouteImplantation
Strength68mg/implant
Market StatusPrescription
CompanyOrganon Usa

4 of 4  
Drug NameNexplanon
PubMed HealthEtonogestrel (Implantation)
Drug ClassesContraceptive, Progestin
Drug LabelNEXPLANON is a radiopaque, progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is white/off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 18). Each impl...
Active IngredientEtonogestrel
Dosage FormImplant
RouteImplantation
Strength68mg/implant
Market StatusPrescription
CompanyOrganon Usa

4.2 Drug Indication

Etonogestrel is administered in subdermal implants as long-acting reversible contraception. It is known to be effective in postpartum insertion including breastfeeding women. Etonogestrel is part of the long-acting contraceptive implants that prevent pregnancy. The implant's effect can remain for 5 years.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Etonogestrel attains its therapeutic effect inhibiting fertility by impairing the release of the luteinizing hormone which is one of the most important reproductive hormones for ovulation. As well, etonogestrel is known to increase the viscosity of the cervical mucus hindering the passage of the spermatozoa and altering the lining in the uterus to prevent the implantation of the fertilized eggs in the endometrium. In clinical trials, etonogestrel was implanted and reported to avoid 100% of pregnancies over a three year period. When the implant was removed, normal periods were reinstalled within 90 days in 91% of the individuals. Fertility was established quickly with 20 reported pregnancies within 3 months of implant removal. The implants of etonogestrel release 40 mcg of etonogestrel daily and they usually provide a continuous contraception effect for 3 years. When the implant is administered, the failure rate is reported to be 0.1%. Some non-contraceptive effects are improved dysmenorrhea. All data of etonogestrel comes from patients between 80-130% of the body mass.


5.2 MeSH Pharmacological Classification

Contraceptive Agents, Female

Chemical substances or agents with contraceptive activity in females. Use for female contraceptive agents in general or for which there is no specific heading. (See all compounds classified as Contraceptive Agents, Female.)


Contraceptive Agents, Hormonal

Contraceptive agents that act on the ENDOCRINE SYSTEM. (See all compounds classified as Contraceptive Agents, Hormonal.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ETONOGESTREL
5.3.2 FDA UNII
304GTH6RNH
5.3.3 Pharmacological Classes
Progestin [EPC]; Progesterone Congeners [CS]
5.4 ATC Code

G03AC08

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

G03AC08 - Etonogestrel


5.5 Absorption, Distribution and Excretion

Absorption

Vaginal administration of etonogestrel is known to be significantly absorbed through the vaginal epithelium but it does not increase the levels of etonogestrel in the urine. On the other hand, oral administration is absorbed in the GI tract and it goes through the first-pass metabolism. When etonogestrel is administered subdermally it is absorbed rapidly into the bloodstream and it presents a bioavailability of 82%. It is reported that the implant releases around 60 mcg per day in the first 3 months and then decreases steady reaching a concentration of 30 mcg at the end of year 2.


Route of Elimination

The elimination of etonogestrel and its metabolites is mainly done renally.


Volume of Distribution

The apparent volume of distribution of etonogestrel is of around 201 L.


Clearance

The clearance rate of etonogestrel is reported to be of 7.5 L/h.


5.6 Metabolism/Metabolites

Etonogestrel is highly metabolized in the liver by the action of the cytochrome isoenzyme 3A4 mainly by the presence of hydroxylation, sulfate conjugation and glucuronide conjugation reactions.


5.7 Biological Half-Life

The elimination half-life of etonogestrel is reported to be of 25 hours which indicates a reversible contraceptive effect.


5.8 Mechanism of Action

Etonogestrel binds with high affinity to the progesterone and estrogen receptors in the target organs. From the target organs, they include the female reproductive tract, mammary gland, hypothalamus, and pituitary. Once bound, this drug changes the synthesis of different proteins which in order decreases the level of gonadotropin-releasing hormone and the luteinizing hormone.


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Etonogestrel

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...

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About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

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Etonogestrel

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PUSHPARAJ TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"ETONOGESTREL MICRONIZED (F.O.C.)","address":"13, SURYODAYA MILL ESTATE,","city":"MUMBAI ,MAHARASHTRA","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"PREGNA INTERNATIONAL LIMITED","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"75","totalValueFC":"4124.3","currency":"EUR","unitRateINR":"6918.8","date":"03-Aug-2024","totalValueINR":"345937.5","totalValueInUsd":"4124.3","indian_port":"Bombay Air","hs_no":"29372300","bill_no":"4868651","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"Kloosterstraat 6 5349 AB OssSDNFSDNF NETHERLANDS","customerAddress":"13, SURYODAYA MILL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729708200,"product":"ETONOGESTREL (QTY:1 X 100 MG, VALUE:USD 843)(FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"ITALY","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0001","unit":"KGS","unitRateFc":"8430000","totalValueFC":"880.1","currency":"USD","unitRateINR":"739527100","date":"24-Oct-2024","totalValueINR":"73952.71","totalValueInUsd":"880.1","indian_port":"Hyderabad Air","hs_no":"29372300","bill_no":"6312966","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK, MD, US 21704, UNITED STATES OF AMER ICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"}]
12-Feb-2021
15-Mar-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - RING;VAGINAL - 0.015MG/24HR;0.12MG/2...DOSAGE - RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR

USFDA APPLICATION NUMBER - 21187

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DOSAGE - IMPLANT;IMPLANTATION - 68MG/IMPLANT

USFDA APPLICATION NUMBER - 21529

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01

Brand Name : Nuvaring

U.S.A
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Brand Name : Nuvaring

U.S.A
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Etonogestrel; Ethinyl Estradiol

Dosage Form :

Dosage Strength : 1 System Vaginal Release  

Price Per Pack (Euro) : 13.45

Published in :

Country : Italy

RX/OTC/DISCN : Class C

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02

Brand Name : Nexplanon

U.S.A
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AACR Annual meeting
Not Confirmed

Brand Name : Nexplanon

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Dosage Form : Implant

Dosage Strength : 68 mg

Price Per Pack (Euro) : 124.85

Published in :

Country : Norway

RX/OTC/DISCN :

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03

Brand Name : Nexplanon

U.S.A
arrow
AACR Annual meeting
Not Confirmed

Brand Name : Nexplanon

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Dosage Form : Implant

Dosage Strength : 68 mg

Price Per Pack (Euro) : 89.74

Published in :

Country : Norway

RX/OTC/DISCN :

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04

Brand Name : Nexplanon

Denmark
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Not Confirmed

Brand Name : Nexplanon

Denmark
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AACR Annual meeting
Not Confirmed

Etonogestrel

Dosage Form : Implant

Dosage Strength : 68 mg

Price Per Pack (Euro) : 124.85

Published in :

Country : Norway

RX/OTC/DISCN :

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Annual Reports

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01

Brand Name : Implanon/Nexplanon

Etonogestrel

arrow
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Not Confirmed

Brand Name : Implanon/Nexplanon

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Women's Healthcare

Currency : USD

2020 Revenue in Millions : 680

2019 Revenue in Millions : 787

Growth (%) : -14

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02

Brand Name : NuvaRing

Etonogestrel

arrow
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Not Confirmed

Brand Name : NuvaRing

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Women's Healthcare

Currency : USD

2020 Revenue in Millions : 237

2019 Revenue in Millions : 879

Growth (%) : -73

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03

Brand Name : Nexplanon/Implanon NXT

Etonogestrel

arrow
AACR Annual meeting
Not Confirmed

Brand Name : Nexplanon/Implanon NXT

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Women's Healthcare

Currency : USD

2021 Revenue in Millions : 769

2020 Revenue in Millions : 680

Growth (%) : 13

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04

Brand Name : NuvaRing

Etonogestrel

arrow
AACR Annual meeting
Not Confirmed

Brand Name : NuvaRing

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Women's Healthcare

Currency : USD

2021 Revenue in Millions : 191

2020 Revenue in Millions : 236

Growth (%) : -19

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05

Brand Name : Nexplanon/Implanon NXT

Etonogestrel

arrow
AACR Annual meeting
Not Confirmed

Brand Name : Nexplanon/Implanon NXT

U.S.A
arrow
AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Women's Health

Currency : USD

2022 Revenue in Millions : 834

2021 Revenue in Millions : 769

Growth (%) : 8

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06

Brand Name : NuvaRing

Etonogestrel

arrow
AACR Annual meeting
Not Confirmed

Brand Name : NuvaRing

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Women's Health

Currency : USD

2022 Revenue in Millions : 173

2021 Revenue in Millions : 191

Growth (%) : -9

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07

Brand Name : Nexplanon/Implanon NXT

Etonogestrel

arrow
AACR Annual meeting
Not Confirmed

Brand Name : Nexplanon/Implanon NXT

U.S.A
arrow
AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Women's Health

Currency : USD

2023 Revenue in Millions : 830

2022 Revenue in Millions : 834

Growth (%) : 0

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08

Brand Name : NuvaRing

Etonogestrel

arrow
AACR Annual meeting
Not Confirmed

Brand Name : NuvaRing

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Women's Health

Currency : USD

2023 Revenue in Millions : 152

2022 Revenue in Millions : 173

Growth (%) : -12

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09

Brand Name : Implanin/Nexplanon

Etonogestrel

arrow
AACR Annual meeting
Not Confirmed

Brand Name : Implanin/Nexplanon

U.S.A
arrow
AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Sexual Health

Currency : USD

2015 Revenue in Millions : 502

2014 Revenue in Millions : 588

Growth (%) : 17%

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10

Brand Name : Implanin

Etonogestrel

arrow
AACR Annual meeting
Not Confirmed

Brand Name : Implanin

U.S.A
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AACR Annual meeting
Not Confirmed

Etonogestrel

Main Therapeutic Indication : Sexual Health

Currency : USD

2014 Revenue in Millions : 24.60%

2013 Revenue in Millions :

Growth (%) :

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Patents & EXCLUSIVITIES

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US Patents

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01

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ORGANON

U.S.A
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ETONOGESTREL

US Patent Number : 8888745

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21529

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-08-28

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02

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Not Confirmed

ORGANON

U.S.A
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Not Confirmed

ETONOGESTREL

US Patent Number : 10821277

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21529

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-05-31

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03

arrow
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Not Confirmed

ORGANON

U.S.A
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Not Confirmed

ETONOGESTREL

US Patent Number : 9757552

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21529

Patent Use Code : U-1

Delist Requested :

Patent Use Description : PREVENTION OF PREGNANC...

Patent Expiration Date : 2030-07-28

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04

arrow
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Not Confirmed

ORGANON

U.S.A
arrow
AACR Annual meeting
Not Confirmed

ETONOGESTREL

US Patent Number : 9757552

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21529

Patent Use Code : U-1

Delist Requested :

Patent Use Description : PREVENTION OF PREGNANC...

Patent Expiration Date : 2030-07-28

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05

arrow
AACR Annual meeting
Not Confirmed

ORGANON

U.S.A
arrow
AACR Annual meeting
Not Confirmed

ETONOGESTREL

US Patent Number : 8722037

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21529

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-09-28

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ABOUT THIS PAGE

Looking for 54048-10-1 / Etonogestrel API manufacturers, exporters & distributors?

Etonogestrel manufacturers, exporters & distributors 1

53

PharmaCompass offers a list of Etonogestrel API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Etonogestrel manufacturer or Etonogestrel supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Etonogestrel manufacturer or Etonogestrel supplier.

PharmaCompass also assists you with knowing the Etonogestrel API Price utilized in the formulation of products. Etonogestrel API Price is not always fixed or binding as the Etonogestrel Price is obtained through a variety of data sources. The Etonogestrel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Etonogestrel

Synonyms

Implanon, 54048-10-1, 3-oxodesogestrel, Nexplanon, 3-ketodesogestrel, 3-keto-desogestrel

Cas Number

54048-10-1

Unique Ingredient Identifier (UNII)

304GTH6RNH

About Etonogestrel

Etonogestrel is a synthetic form of the naturally occurring female sex hormone progesterone. Etonogestrel binds to the cytoplasmic progesterone receptors in the reproductive system and subsequently activates progesterone receptor mediated gene expression. As a result of the negative feedback mechanism, luteinizing hormone (LH) release is inhibited, which leads to an inhibition of ovulation and an alteration in the cervical mucus and endometrium.

Nexplanon Manufacturers

A Nexplanon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexplanon, including repackagers and relabelers. The FDA regulates Nexplanon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexplanon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Nexplanon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Nexplanon Suppliers

A Nexplanon supplier is an individual or a company that provides Nexplanon active pharmaceutical ingredient (API) or Nexplanon finished formulations upon request. The Nexplanon suppliers may include Nexplanon API manufacturers, exporters, distributors and traders.

click here to find a list of Nexplanon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Nexplanon USDMF

A Nexplanon DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexplanon active pharmaceutical ingredient (API) in detail. Different forms of Nexplanon DMFs exist exist since differing nations have different regulations, such as Nexplanon USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Nexplanon DMF submitted to regulatory agencies in the US is known as a USDMF. Nexplanon USDMF includes data on Nexplanon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexplanon USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Nexplanon suppliers with USDMF on PharmaCompass.

Nexplanon NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Nexplanon as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Nexplanon API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Nexplanon as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Nexplanon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nexplanon NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Nexplanon suppliers with NDC on PharmaCompass.

Nexplanon GMP

Nexplanon Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Nexplanon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Nexplanon GMP manufacturer or Nexplanon GMP API supplier for your needs.

Nexplanon CoA

A Nexplanon CoA (Certificate of Analysis) is a formal document that attests to Nexplanon's compliance with Nexplanon specifications and serves as a tool for batch-level quality control.

Nexplanon CoA mostly includes findings from lab analyses of a specific batch. For each Nexplanon CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Nexplanon may be tested according to a variety of international standards, such as European Pharmacopoeia (Nexplanon EP), Nexplanon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nexplanon USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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