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Last Updated: May 9, 2021

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NEXPLANON Drug Profile

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

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

This drug has one hundred and three patent family members in thirty-three 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

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Drug patent expirations by year for NEXPLANON
Drug Prices for NEXPLANON

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Recent Clinical Trials for NEXPLANON

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

SponsorPhase
Kenya Medical Research InstitutePhase 4
United States Agency for International Development (USAID)Phase 4
CONRADPhase 4

See all NEXPLANON clinical trials

Pharmacology for NEXPLANON
Drug ClassProgestin

US Patents and Regulatory Information for NEXPLANON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Organon Usa Inc NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529-002 May 31, 2011 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for NEXPLANON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0303306 099C0041 Belgium   Get Started for $10 PRODUCT NAME: ETONOGESTREL; NATL. REGISTRATION NO/DATE: 52 IS 296 F 14 19990531; FIRST REGISTRATION: NL RVG 21168 19980825
0303306 29/1999 Austria   Get Started for $10 PRODUCT NAME: ETONOGESTREL; NAT. REGISTRATION NO/DATE: 1-22964 19990330; FIRST REGISTRATION: NL 21168 19980825
0303306 SPC/GB99/044 United Kingdom   Get Started for $10 PRODUCT NAME: ETONOGESTREL; REGISTERED: NL RGV21168 19980825; UK 00065/0161 19990609
0303306 C980027 Netherlands   Get Started for $10 PRODUCT NAME: ETONOGESTREL; REGISTRATION NO/DATE: RVG 21168 19980825
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Express Scripts
Boehringer Ingelheim
Moodys
Baxter

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