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Last Updated: June 14, 2024

Etonogestrel - Generic Drug Details


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What are the generic drug sources for etonogestrel and what is the scope of freedom to operate?

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

Etonogestrel has one hundred and five patent family members in thirty-five countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for etonogestrel
Generic Entry Date for etonogestrel*:
Constraining patent/regulatory exclusivity:
Dosage:
IMPLANT;IMPLANTATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for etonogestrel

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

SponsorPhase
Sixth Affiliated Hospital, Sun Yat-sen UniversityPhase 2/Phase 3
Oregon Health and Science UniversityEarly Phase 1
University of PennsylvaniaPhase 4

See all etonogestrel clinical trials

Pharmacology for etonogestrel
Drug ClassProgestin

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 NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 13, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Organon IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Organon NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 13, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Organon NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 13, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Organon NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 13, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for etonogestrel

Country Patent Number Title Estimated Expiration
Norway 20073749 ⤷  Sign Up
Lithuania 3417905 ⤷  Sign Up
European Patent Office 1984063 KIT ET MÉTHODE POUR UN DISPOSITIF POUR INSÉRER UN IMPLANT (KIT FOR AND METHOD OF ASSEMBLING AN APPLICATOR FOR INSERTING AN IMPLANT) ⤷  Sign Up
European Patent Office 1841492 APPAREIL DE POSE D'IMPLANT (APPLICATOR FOR INSERTING AN IMPLANT) ⤷  Sign Up
Japan 2008528084 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2005089814 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for etonogestrel

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.