Viewing data from:

NUVARING

NDA

ETHINYL ESTRADIOL; ETONOGESTREL | N021187 | ORGANON USA LLC A SUB OF ORGANON AND CO

1 strength0 unique patents0 unique exclusivities

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

7 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®NCT00475553	N/A	Completed	Scott and White Hospital & Clinic	75	2006-05 → 2008-05
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS NCT04257500	Phase 4	Completed	Andrea Roe, MD, MPH	22	2020-09-03 → 2025-08-22
Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART NCT01903031	Phase 2	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	84	2014-12-30 → 2016-10-10
PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra NCT00269620	Phase 4	Completed	University of Pittsburgh	500	2005-06 → 2006-12
The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism NCT01087879	N/A	Completed	University of Oulu	45	2007-10 → 2011-01
Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers NCT01448291	Phase 4	UNKNOWN	Eastern Virginia Medical School	30	2011-10 → 2013-03
Application for the Etonogestrel/Ethinyl Estradiol Ring NCT03120728	Phase 4	UNKNOWN	University of Southern California	36	2017-07-10 → 2018-07-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$155.89

per ea

Lowest NADAC/Unit

$47.89

per ea

Brand NDCs

Generic NDCs

Avg Brand: $155.89

Avg Generic: $47.89

69% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206014603NUVARING VAGINAL RING	$155.89	EA	Brand	$47.89	2026-06-17
66993060536ETONOGESTREL-EE VAGINAL RING	$47.89	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$98.54

Highest Price

$480.53

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0605-36ETHINYL ESTRADIOL/ETONOGESTREL 0.015MG/0.12MG	$153.98	FSS	Prasco, LLC	06/30/2026
66993-0605-36ETHINYL ESTRADIOL/ETONOGESTREL 0.015MG/0.12MG	$98.54	Big4	Prasco, LLC	06/30/2026
59212-0146-03NUVARING	$480.53	FSS	Amdipharm Limited	09/28/2026
59212-0146-03NUVARING	$366.85	Big4	Amdipharm Limited	09/28/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Nuvaring (2024)

Total Spending

$168K

Total Claims

520

Beneficiaries

148

Avg Cost/Unit

$152.65

Spending Trend

$59K(2021)→$233K(2022)→$197K(2023)→$168K(2024)

YoY Change:-7.3%

5yr CAGR:-2.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Jun 3, 2024	SUPPL -41	View Letter (PDF)
May 3, 2022	SUPPL -40	View Letter (PDF)
May 13, 2019	SUPPL -37	View Letter (PDF)
Dec 7, 2018	SUPPL -36	View Letter (PDF)
Dec 7, 2018	SUPPL -35	View Letter (PDF)
Feb 14, 2018	SUPPL -31	View Letter (PDF)
Aug 15, 2017	SUPPL -32	View Letter (PDF)
Jun 2, 2017	SUPPL -28	View Letter (PDF)
Oct 4, 2016	SUPPL -27	View Letter (PDF)
Nov 3, 2014	SUPPL -25	View Letter (PDF)
Jun 19, 2014	SUPPL -24	View Letter (PDF)
Oct 21, 2013	SUPPL -22	View Letter (PDF)
Oct 21, 2013	SUPPL -21	View Letter (PDF)
May 5, 2008	SUPPL -18	View Letter (PDF)
Oct 4, 2007	SUPPL -17	View Letter (PDF)
Aug 3, 2005	SUPPL -12	View Letter (PDF)
Mar 10, 2004	SUPPL -8	View Letter (PDF)
Mar 2, 2004	SUPPL -7	View Letter (PDF)
Oct 3, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.015MG/24HR;0.12MG/24HR

RLDAB

0 patents0 exclusivities▴

RING;VAGINAL | Approved: Oct 3, 2001

No patent or exclusivity listings for this strength.