NEXPLANON Drug Patent Profile

Which patents cover Nexplanon, and what generic alternatives are available?

Nexplanon is a drug marketed by Organon and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and four patent family members in thirty-four countries.

The generic ingredient in NEXPLANON 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 Nexplanon

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NEXPLANON

International Patents:	104
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	29
Patent Applications:	2,457
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEXPLANON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXPLANON
What excipients (inactive ingredients) are in NEXPLANON?	NEXPLANON excipients list
DailyMed Link:	NEXPLANON at DailyMed

See drug prices for NEXPLANON

Recent Clinical Trials for NEXPLANON

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

Sponsor	Phase
Oregon Health and Science University	Early Phase 1
Saskatchewan Health Authority - Regina Area	Phase 2
University of Saskatchewan	Phase 2

See all NEXPLANON clinical trials

Pharmacology for NEXPLANON

Drug Class

Progestin

Anatomical Therapeutic Chemical (ATC) Classes for NEXPLANON

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 NEXPLANON

NEXPLANON is protected by four US patents.

Patents protecting NEXPLANON

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 31, 2011		RX	Yes	Yes			Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 31, 2011		RX	Yes	Yes			Y
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 31, 2011		RX	Yes	Yes			Y

International Patents for NEXPLANON

See the table below for patents covering NEXPLANON around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1729819
Austria	399569
China	101141994	Applicator for inserting an implant

Supplementary Protection Certificates for NEXPLANON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0303306	29/1999	Austria		PRODUCT NAME: ETONOGESTREL; NAT. REGISTRATION NO/DATE: 1-22964 19990330; FIRST REGISTRATION: NL 21168 19980825
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