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NDA

ETHINYL ESTRADIOL; LEVONORGESTREL | N204061 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

Today

8415332

Mar. 11, 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

44 trials from ClinicalTrials.gov — 1 recruiting, 37 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies NCT03557619	Phase 1	Recruiting	AbbVie	12	2019-07-30 → 2026-03-21
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale NCT00394771	Phase 2	Completed	Duramed Research	567	2006-10 → 2008-03
Hormonal Birth Control and the Risk of Acquiring HIV NCT00006324	N/A	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	6,360	1999-12 → 2002-12
The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females NCT00254800	Phase 1	Completed	AstraZeneca	38	2005-11 → 2006-08
Oral Contraceptive Efficacy and Body Weight NCT00662454	Phase 4	Completed	Oregon Health and Science University	120	2006-01 → 2006-05
A Study in Healthy Participants to Evaluate the Effects of Multiple Doses of JNJ-55308942 on Cytochrome P450 Substrate Activity and on the Pharmacokinetics of Levonorgestrel/Ethinyl Estradiol NCT03547024	Phase 1	Completed	Janssen-Cilag International NV	14	2018-06-08 → 2018-08-30
Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel NCT03359057	Phase 3	Completed	Galeno Desenvolvimento de Pesquisas Clínicas	36	2013-02-26 → 2013-09-17
Human Ovarian Follicular Dynamics and Emergency Contraception NCT00204451	Phase 4	Completed	University of Saskatchewan	40	2005-07 → 2006-06
Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive NCT00213096	Phase 2	Completed	Population Council	50	2003-03 → 2004-02
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids NCT04267250	Phase 1	Completed	Pfizer	18	2020-08-24 → 2020-11-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1.59

per ea

Lowest NADAC/Unit

$1.59

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00093603182RIVELSA TABLET	$1.59	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$156.73

Highest Price

$505.97

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00093-6031-82RIVELSA TAB	$505.97	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-6031-82RIVELSA TAB	$156.73	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Aug 5, 2022	SUPPL -5	View Letter (PDF)
Aug 5, 2022	SUPPL -6	View Letter (PDF)
May 3, 2022	SUPPL -8	View Letter (PDF)
Aug 15, 2017	SUPPL -2	View Letter (PDF)
Mar 29, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

RLDAB

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Mar 28, 2013

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8415332	Mar 11, 2029	—	—	Yes	—	—