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Last Updated: December 4, 2022

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-four countries.

There are five drug master file entries for etonogestrel.

Summary for etonogestrel
Recent Clinical Trials for etonogestrel

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

SponsorPhase
Lupin Research IncPhase 2
Saskatchewan Health Authority - Regina AreaPhase 2
University of SaskatchewanPhase 2

See all etonogestrel clinical trials

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 31, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Organon NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Organon NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for etonogestrel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 See Plans and Pricing See Plans and Pricing
Organon IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for etonogestrel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0303306 C980027 Netherlands See Plans and Pricing PRODUCT NAME: ETONOGESTREL; REGISTRATION NO/DATE: RVG 21168 19980825
0303306 099C0041 Belgium See Plans and Pricing PRODUCT NAME: ETONOGESTREL; NATL. REGISTRATION NO/DATE: 52 IS 296 F 14 19990531; FIRST REGISTRATION: NL RVG 21168 19980825
0303306 SPC/GB99/044 United Kingdom See Plans and Pricing 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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