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Last Updated: December 6, 2019

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ETONOGESTREL - Generic Drug Details

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What are the generic sources for etonogestrel and what is the scope of patent protection?

Etonogestrel is the generic ingredient in two branded drugs marketed by Organon Usa Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etonogestrel has eighty-two patent family members in thirty-one countries.

There are five drug master file entries for etonogestrel. One supplier is listed for this compound.

Summary for ETONOGESTREL
Recent Clinical Trials for ETONOGESTREL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of New MexicoPhase 4
National Institutes of Health (NIH)Phase 4
Emory UniversityPhase 4

See all ETONOGESTREL clinical trials

Pharmacology for ETONOGESTREL
Drug ClassProgestin
Synonyms for ETONOGESTREL
(17-alpha)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one
(17|A)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one
(17alpha)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one
(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
(8S,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-11-methylene-2,6,7,8,9,10,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one
(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
(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
048E101
13-Ethyl-11-methylene-18,19-dinor-17-alpha-pregn-4-en-20-yn-3-one
13-Ethyl-17-hydroxy-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one
13-Ethyl-17-hydroxy-11-methylidene-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one (3-Ketodesogestrel)
165050-21-5
17-Ethinyl-17-beta-hydroxy-18-methyl-11-methylene-4-estren-3-one
17alpha-ethynyl-17beta-hydroxy-11-methylidene-18a-homo-estr-4-en-3-one
18,19-Dinor-17alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-
18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-, (17-alpha)-
3-Keto Desogestrel
3-Keto-desogestrel
3-Ketodesogestrel
3-Ketodesogestrel|||3-Oxodesogestrel
3-Oxodesogestrel
3-Oxodesogestrel;3-keto-Desogestrel
304GTH6RNH
54048-10-1
AC1OCEK1
ACN-037292
AKOS030526156
AN-40607
BC252319
BCP28481
BDBM50423516
C-23775
CAS-54048-10-1
CC-28331
CHEBI:50777
CHEMBL1531
CS-2884
D04104
DB00294
Desogestrel Related Compound C, United States Pharmacopeia (USP) Reference Standard
DSSTox_CID_26782
DSSTox_GSID_46782
DSSTox_RID_81900
DTXSID9046782
EINECS 258-936-2
Etonogestrel (3-Ketodesogestrel)
Etonogestrel (USAN/INN)
Etonogestrel [USAN:INN:BAN]
Etonogestrel, >=98% (HPLC)
Etonogestrel, United States Pharmacopeia (USP) Reference Standard
etonogestrelum
FT-0652914
GTPL7590
HY-B0652
Implanon
Implanon (TN)
MolPort-003-847-336
NCGC00168777-01
nexplanon
ORG 3236
Org-3236
s4673
SCHEMBL117703
Tox21_112638
UNII-304GTH6RNH
ZINC11680067

US Patents and Regulatory Information for ETONOGESTREL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Organon Usa Inc IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 DISCN No No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ETONOGESTREL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0303306 29/1999 Austria   Start Trial PRODUCT NAME: ETONOGESTREL; NAT. REGISTRATION NO/DATE: 1-22964 19990330; FIRST REGISTRATION: NL 21168 19980825
0303306 099C0041 Belgium   Start Trial PRODUCT NAME: ETONOGESTREL; NATL. REGISTRATION NO/DATE: 52 IS 296 F 14 19990531; FIRST REGISTRATION: NL RVG 21168 19980825
0303306 C980027 Netherlands   Start Trial PRODUCT NAME: ETONOGESTREL; REGISTRATION NO/DATE: RVG 21168 19980825
0303306 SPC/GB99/044 United Kingdom   Start Trial PRODUCT NAME: ETONOGESTREL; REGISTERED: NL RGV21168 19980825; UK 00065/0161 19990609
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
McKinsey
Johnson and Johnson
Moodys
Baxter

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