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Last Updated: May 26, 2022

NEXPLANON Drug Patent Profile


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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 five patent family members in thirty-four countries.

The generic ingredient in NEXPLANON is etonogestrel. There are five drug master file entries 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

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Drug patent expirations by year for NEXPLANON
Drug Prices for NEXPLANON

See drug prices for NEXPLANON

Recent Clinical Trials for NEXPLANON

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

SponsorPhase
Saskatchewan Health Authority - Regina AreaPhase 2
University of SaskatchewanPhase 2
Kenya Medical Research InstitutePhase 4

See all NEXPLANON clinical trials

US Patents and Regulatory Information for NEXPLANON

NEXPLANON is protected by four US patents.

Patents protecting NEXPLANON

Kit for and method of assembling an applicator for inserting an implant
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

X-ray visible drug delivery device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicator for inserting an implant
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicator for inserting an implant
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF PREGNANCY

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Organon NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Organon NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Organon NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for NEXPLANON

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

Country Patent Number Title Estimated Expiration
Norway 20073749 See Plans and Pricing
Netherlands 980027 See Plans and Pricing
Canada 1309949 IMPLANT CONTRACEPTIF (CONTRACEPTIVE IMPLANT) See Plans and Pricing
Ireland 882118 See Plans and Pricing
Malaysia 142649 X-RAY VISIBLE DRUG DELIVERY DEVICE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEXPLANON

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

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