Viewing data from:

SEASONIQUE

NDA

ETHINYL ESTRADIOL; LEVONORGESTREL | N021840 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

Today

7855190

Dec. 5, 2028

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
TEVA WOMEN'S HEALTH, INC. v. MYLAN PHARMACEUTICALS, INC. et al 3:2010cv01235 1 patentANDA 020492ethinyl estradiol and levonorgestrel	D.N.J.	2010-03-09	Terminated 2010-11-30	—
TEVA WOMEN'S HEALTH, INC. v. LUPIN, LTD. et al 3:2010cv00603 1 patentANDA 091467ethinyl estradiol and levonorgestrel	D.N.J.	2010-02-03	Terminated 2012-06-29	—

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

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

$0.1350

per ea

Lowest NADAC/Unit

$0.1350

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00093313482CAMRESE 0.15-0.03-0.01 MG TAB	$0.1350	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

$45.90

Highest Price

$129.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00093-3134-82CAMRESE TABLETS	$129.55	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-3134-82CAMRESE TABLETS	$45.90	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

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

Medicare Part D Spending

CMS annual spending data for Seasonique (2024)

Total Spending

$4K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$4.39

Spending Trend

$96K(2019)→$100K(2020)→$101K(2021)→$123K(2022)→$100K(2023)→$4K(2024)

YoY Change:-18.1%

5yr CAGR:+0.6%

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 30, 2023	SUPPL -12	View Letter (PDF)
Jan 30, 2023	SUPPL -13	View Letter (PDF)
May 3, 2022	SUPPL -15	View Letter (PDF)
Aug 15, 2017	SUPPL -11	View Letter (PDF)
Aug 9, 2010	SUPPL -8	View Letter (PDF)
May 26, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.03MG,0.01MG;0.15MG,N/A

RLDAB

1 patent0 exclusivities▴

TABLET;ORAL | Approved: May 25, 2006

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7855190	Dec 5, 2028	—	—	—		—