Etonogestrel - PharmaKB

Etonogestrel

Eluryng, Enilloring, Ethinyl Estradiol / Etonogestrel, Haloette, Nexplanon, Nuvaring (etonogestrel) is a small molecule pharmaceutical. Etonogestrel was first approved as Nuvaring on 2001-10-03.

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Financial

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YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion date

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Commercial

Therapeutic Areas

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Trade Name

FDA

EMA

Nexplanon (discontinued: Nexplanon)

Combinations

Eluryng, Enilloring, Ethinyl estradiol; etonogestrel, Haloette, Nuvaring (discontinued: Veraring)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Etonogestrel

Tradename	Company	Number	Date	Products
NEXPLANON	Organon	N-021529 RX	2011-05-13	1 products, RLD, RS

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Ethinyl estradiol

Etonogestrel

Tradename	Company	Number	Date	Products
NUVARING	Organon	N-021187 RX	2001-10-03	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
eluryng	ANDA	2024-08-20
enilloring	ANDA	2024-06-24
etonogestrel and ethinyl estradiol	ANDA	2022-09-30
etonogestrel and ethinyl estradiol vaginal	ANDA	2024-07-08
etonogestrel and ethinyl estradiol vaginal ring	ANDA	2024-06-24
etonogestrel/ethinyl estradiol	NDA authorized generic	2024-06-21
haloette	ANDA	2024-04-19
nexplanon	New Drug Application	2024-09-23
nuvaring	New Drug Application	2024-06-01

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
prostatic neoplasms	—	D011471	C61
breast neoplasms	EFO_0003869	D001943	C50
menorrhagia	EFO_0003945	D008595	N92.0
primary ovarian insufficiency	EFO_0004266	D016649	E28.3
hot flashes	—	D019584	—
hypogonadism	HP_0000044	D007006	E23.0
premature menopause	HP_0008209	D008594	E28.31

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Etonogestrel, Implanon, Organon
9757552	2030-07-28	DP	U-1
8722037	2027-09-28	DP
10821277	2027-05-31	DP
8888745	2026-08-28	DP

ATC Codes

G: Genito urinary system and sex hormones

— G03: Sex hormones and modulators of the genital system

— G03A: Hormonal contraceptives for systemic use

— G03AC: Progestogen systemic hormonal contraceptives

— G03AC08: Etonogestrel

HCPCS

Code	Description
J7295	Ethinyl estradiol and etonogestrel 0.015mg, 0.12mg per 24 hours; monthly vaginal ring, each
J7307	Etonogestrel (contraceptive) implant system, including implant and supplies

Clinical

Clinical Trials

146 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Contraception	D003267	—	—	7	7	10	25	30	78
Hemorrhage	D006470	MP_0001914	R58	1	2	2	8	3	15
Uterine hemorrhage	D014592	—	—	1	5	—	4	1	10
Contraception behavior	D003268	—	—	1	—	1	2	5	9
Hiv infections	D015658	EFO_0000764	B20	—	2	—	3	3	8
Hiv	D006678	—	—	—	1	—	4	3	8
Drug interactions	D004347	—	—	—	—	—	3	2	5
Emergencies	D004630	—	—	—	—	—	3	2	5
Metrorrhagia	D008796	HP_0100608	N92.1	—	—	—	2	1	3
Postcoital contraception	D044363	—	—	—	—	—	2	1	3

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Dysmenorrhea	D004412	HP_0100607	N94.6	—	2	2	—	—	4
Systemic lupus erythematosus	D008180	HP_0002725	M32	—	1	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyperplasia	D006965	EFO_0000536	—	—	1	—	—	1	2
Prostatic hyperplasia	D011470	EFO_0000284	N40	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pregnancy	D011247	EFO_0002950	Z33.1	1	—	—	—	2	3
Pregnancy rate	D018873	—	—	1	—	—	—	—	1
Migraine disorders	D008881	EFO_0003821	G43	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hormonal contraception	D000080282	—	—	—	—	—	—	2	2
Body weight	D001835	EFO_0004338	—	—	—	—	—	2	2
Weight loss	D015431	HP_0001824	—	—	—	—	—	2	2
Obesity	D009765	EFO_0001073	E66.9	—	—	—	—	2	2
Microbiota	D064307	—	—	—	—	—	—	1	1
Pharmacokinetics	D010599	—	—	—	—	—	—	1	1
Opioid-related disorders	D009293	EFO_0005611	F11	—	—	—	—	1	1
Sexual behavior	D012725	—	—	—	—	—	—	1	1
Sexually transmitted diseases	D012749	—	A50-A64	—	—	—	—	1	1
Body weight changes	D001836	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Etonogestrel
INN	etonogestrel
Description	Etonogestrel is a medication which is used as a means of birth control for women. It is available as an implant placed under the skin of the upper arm under the brand names Nexplanon and Implanon. It is a progestin that is also used in combination with ethinylestradiol, an estrogen, as a vaginal ring under the brand names NuvaRing and Circlet. Etonogestrel is effective as a means of birth control and lasts at least three or four years with some data showing effectiveness for five years. Following removal, fertility quickly returns.
Classification	Small molecule
Drug class	estrogens; progestins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@@H]4[C@H]3C(=C)C[C@@]21CC

Identifiers

PDB	—
CAS-ID	54048-10-1
RxCUI	—
ChEMBL ID	CHEMBL1531
ChEBI ID	50777
PubChem CID	21729469
DrugBank	DB00294
UNII ID	304GTH6RNH (ChemIDplus, GSRS)

Target

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Variants

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Financial

Revenue by drug

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Nexplanon – Organon

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Nexplanon – Merck & Co

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Nuvaring – Organon

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Nuvaring – Merck & Co

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Estimated US medical usage

Etonogestrel

Ethinyl estradiol

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Etonogestrel

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Eluryng, Enilloring, Etonogestrel and ethinyl estradiol, Etonogestrel and ethinyl estradiol vaginal, Etonogestrel and ethinyl estradiol vaginal ring, Etonogestrel/ethinyl estradiol, Haloette, Nuvaring

Adverse Events

Top Adverse Reactions

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77,232 adverse events reported

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