Viewing data from:

IMPLANON

NDA

ETONOGESTREL | N021529 | ORGANON USA LLC

2 strengths4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (2)Active (2)TodayExclusivity

2027

2028

2029

2030

Today

Sep. 28, 2027

Aug. 28, 2026

Jul. 28, 2030

May. 31, 2027

D-199

Jan. 16, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME B.V. et al v. XIROMED PHARMA ESPAA, S.L. et al 2:2025cv02254 2 patentsANDA 217698etonogestrel	D.N.J.	2025-04-02	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nexplanon (2023)

Total Spending

$402K

Total Claims

346

Beneficiaries

346

Avg Cost/Unit

$1160.47

Spending Trend

$67K(2021)→$273K(2022)→$402K(2023)

YoY Change:+3.2%

5yr CAGR:+2.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

GEDEON RICHTER PLCETONOGESTREL

DMF 119971996

ASPEN OSS BVETONOGESTREL

DMF 122931996

STERLING SPAETONOGESTREL

DMF 246512011

INDUSTRIALE CHIMICA SRLETONOGESTREL

DMF 291652015

CURIA SPAIN SAUETONOGESTREL

DMF 322712017

STEROID SPAETONOGESTREL

DMF 394552024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
May 29, 2026	SUPPL -28	View Letter (PDF)
Jan 22, 2026	SUPPL -27	View Letter (PDF)
Oct 3, 2023	SUPPL -21	View Letter (PDF)
Oct 3, 2023	SUPPL -24	View Letter (PDF)
Oct 3, 2023	SUPPL -22	View Letter (PDF)
Sep 25, 2020	SUPPL -19	View Letter (PDF)
Sep 25, 2020	SUPPL -20	View Letter (PDF)
Apr 24, 2019	SUPPL -18	View Letter (PDF)
May 23, 2017	SUPPL -15	View Letter (PDF)
Mar 16, 2016	SUPPL -13	View Letter (PDF)
Aug 21, 2015	SUPPL -11	View Letter (PDF)
Oct 1, 2013	SUPPL -10	View Letter (PDF)
Feb 3, 2012	SUPPL -6	View Letter (PDF)
May 19, 2011	SUPPL -7	View Letter (PDF)
Feb 23, 2009	SUPPL -4	View Letter (PDF)
Jan 25, 2007	SUPPL -1	View Letter (PDF)
Jul 21, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 68MG/IMPLANT

1 patent0 exclusivities▴

IMPLANT;IMPLANTATION | Approved: Jul 17, 2006

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9757552	Jul 28, 2030	—	—	Yes		—

#002 — 68MG/IMPLANT

RLD

4 patents1 exclusivity▾

IMPLANT;IMPLANTATION | Approved: May 13, 2011