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Last Updated: June 14, 2021

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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 Usa Inc 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 three patent family members in thirty-three countries.

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

Recent Clinical Trials for ETONOGESTREL

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

SponsorPhase
University of Colorado, DenverN/A
United States Agency for International Development (USAID)Phase 4
CONRADPhase 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 Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Organon Usa Inc IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 DISCN No No   Get Started Free   Get Started Free Y   Get Started Free
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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 Usa Inc IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006   Get Started Free   Get Started Free
Organon Usa Inc IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006   Get Started Free   Get Started Free
>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 099C0041 Belgium   Get Started Free 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   Get Started Free PRODUCT NAME: ETONOGESTREL; REGISTERED: NL RGV21168 19980825; UK 00065/0161 19990609
0303306 29/1999 Austria   Get Started Free PRODUCT NAME: ETONOGESTREL; NAT. REGISTRATION NO/DATE: 1-22964 19990330; FIRST REGISTRATION: NL 21168 19980825
0303306 C980027 Netherlands   Get Started Free PRODUCT NAME: ETONOGESTREL; REGISTRATION NO/DATE: RVG 21168 19980825
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Moodys
Boehringer Ingelheim
McKesson
Merck

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