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.

Summary for ETONOGESTREL

International Patents:	105
US Patents:	4
Tradenames:	2
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	75
Patent Applications:	3,462
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ETONOGESTREL
What excipients (inactive ingredients) are in ETONOGESTREL?	ETONOGESTREL excipients list
DailyMed Link:	ETONOGESTREL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ETONOGESTREL

Generic Entry Date for ETONOGESTREL^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Bill and Melinda Gates Foundation	Phase 4
Lori Gawron	Phase 4
Planned Parenthood Association of Utah	Phase 4

See all ETONOGESTREL clinical trials

Pharmacology for ETONOGESTREL

Drug Class	Progestin

Anatomical Therapeutic Chemical (ATC) Classes for ETONOGESTREL

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for ETONOGESTREL

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Glossary

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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	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	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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006	⤷ Sign Up	⤷ Sign Up
Organon	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ETONOGESTREL

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Country	Patent Number	Title	Estimated Expiration
Ukraine	88674	АППЛИКАТОР ДЛЯ ВВЕДЕНИЯ ИМПЛАНТАТА;АПЛІКАТОР ДЛЯ ВВЕДЕННЯ ІМПЛАНТАТА (APPLICATOR FOR INSERTING AN IMPLANT)	⤷ Sign Up
Australia	2006207455	Applicator for inserting an implant	⤷ Sign Up
Mexico	2007008881	APLICADOR PARA INSERTAR UN IMPLANTE. (APPLICATOR FOR INSERTING AN IMPLANT.)	⤷ Sign Up
Japan	2009523515		⤷ Sign Up
Poland	3417905		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ETONOGESTREL

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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	C980027	Netherlands	⤷ Sign Up	PRODUCT NAME: ETONOGESTREL; REGISTRATION NO/DATE: RVG 21168 19980825
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	SPC/GB99/044	United Kingdom	⤷ Sign Up	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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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.