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Last Updated: March 6, 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 patent family members in thirty-three countries.

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

Summary for etonogestrel
International Patents:100
US Patents:4
Tradenames:2
Applicants:1
NDAs:1
Drug Master File Entries: 5
Suppliers / Packagers: 1
Bulk Api Vendors: 53
Clinical Trials: 58
Patent Applications: 2,527
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in etonogestrel?etonogestrel excipients list
DailyMed Link:etonogestrel at DailyMed
Recent Clinical Trials for etonogestrel

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

SponsorPhase
University of Colorado, DenverPhase 4
Merck Sharp & Dohme Corp.Early Phase 1
University of UtahEarly Phase 1

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 IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 DISCN No No   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
>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 SPC/GB99/044 United Kingdom   Start Trial PRODUCT NAME: ETONOGESTREL; REGISTERED: NL RGV21168 19980825; UK 00065/0161 19990609
0303306 29/1999 Austria   Start Trial PRODUCT NAME: ETONOGESTREL; NAT. REGISTRATION NO/DATE: 1-22964 19990330; FIRST REGISTRATION: NL 21168 19980825
0303306 C980027 Netherlands   Start Trial 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:

McKinsey
Harvard Business School
Merck
Mallinckrodt
AstraZeneca
Medtronic

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