IMPLANON Drug Patent Profile

When do Implanon patents expire, and when can generic versions of Implanon launch?

Implanon is a drug marketed by Organon and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-three patent family members in twenty-seven countries.

The generic ingredient in IMPLANON is etonogestrel. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the etonogestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Implanon

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 28, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IMPLANON

International Patents:	33
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	25
Patent Applications:	2,161
Formulation / Manufacturing:	see details
DailyMed Link:	IMPLANON at DailyMed

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

NDA:

021529

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 IMPLANON

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

Sponsor	Phase
United States Agency for International Development (USAID)	Phase 4
Kenya Medical Research Institute	Phase 4
Eastern Virginia Medical School	Phase 4

See all IMPLANON clinical trials

Pharmacology for IMPLANON

Drug Class

Progestin

Anatomical Therapeutic Chemical (ATC) Classes for IMPLANON

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 IMPLANON

IMPLANON is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting IMPLANON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006		DISCN	No	No			Y

Expired US Patents for IMPLANON

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

International Patents for IMPLANON

When does loss-of-exclusivity occur for IMPLANON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Egypt

Latvia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering IMPLANON around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	438688
Canada	2559250	DISPOSITIF D'ADMINISTRATION DE MEDICAMENTS VISIBLE AUX RAYONS X (X-RAY VISIBLE DRUG DELIVERY DEVICE)
Argentina	059069	KIT Y METODO PARA ENSAMBLAR UN APLICADOR PARA INSERTAR UN IMPLANTE
Ukraine	88674	АППЛИКАТОР ДЛЯ ВВЕДЕНИЯ ИМПЛАНТАТА;АПЛІКАТОР ДЛЯ ВВЕДЕННЯ ІМПЛАНТАТА (APPLICATOR FOR INSERTING AN IMPLANT)
Germany	602005007873
South Korea	20070027530	X-RAY VISIBLE DRUG DELIVERY DEVICE
Ukraine	89518	АППЛИКАТОР ДЛЯ ВВЕДЕНИЯ ИМПЛАНТАТА;АПЛІКАТОР ДЛЯ ВВЕДЕННЯ ІМПЛАНТАТА (APPLICATOR FOR INSERTING AN IMPLANT)

Supplementary Protection Certificates for IMPLANON

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