IMPLANON Drug Patent Profile

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When do Implanon patents expire, and what generic alternatives are available?

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

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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:	2,000
DailyMed Link:	IMPLANON at DailyMed

Drug patent expirations by year for IMPLANON

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

Generic Entry Date for IMPLANON^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Eastern Virginia Medical School	Phase 4
CONRAD	Phase 4
United States Agency for International Development (USAID)	Phase 4

See all IMPLANON clinical trials

Pharmacology for IMPLANON

Drug Class	Progestin

US Patents and Regulatory Information for IMPLANON

IMPLANON is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IMPLANON is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Applicator for inserting an implant
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF PREGNANCY

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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	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006		DISCN	No	No	⤷ 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 IMPLANON

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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 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

Patent: 359
Patent: x-ray visible drug delivery device
Estimated Expiration: ⤷ Sign Up

Latvia

Patent: 521
Patent: X-RAY VISIBLE DRUG DELIVERY DEVICE
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Finland	3417905		⤷ Sign Up
Japan	4876077		⤷ Sign Up
Ukraine	89518	АППЛИКАТОР ДЛЯ ВВЕДЕНИЯ ИМПЛАНТАТА;АПЛІКАТОР ДЛЯ ВВЕДЕННЯ ІМПЛАНТАТА (APPLICATOR FOR INSERTING AN IMPLANT)	⤷ Sign Up
Norway	20064716		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IMPLANON

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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