Viewing data from:

SEASONALE

NDA

ETHINYL ESTRADIOL; LEVONORGESTREL | N021544 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

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

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Duramed Research, Inc. FDA-2006-P-0348 · 5 docket documents Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, filed this citizen petition on July 14, 2006, requesting that the FDA require all Abbreviated New Drug Applications referencing Duramed's NDA No. 21-544 for Seasonale (0.03 mg ethinyl estradiol/0.15 mg levonorgestrel) to conduct bioequiva	505(q)	2009-03-24	Withdrawn	Duramed Research, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

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

$0.1866

per ea

Lowest NADAC/Unit

$0.1866

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00555912366JOLESSA 0.15 MG-0.03 MG TABLET	$0.1866	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

$97.48

Highest Price

$144.83

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00555-9123-66JOLESSA 0.15MG/0.03MG TAB,EC,91	$144.83	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00555-9123-66JOLESSA 0.15MG/0.03MG TAB,EC,91	$97.48	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 30, 2023	SUPPL -14	View Letter (PDF)
Jan 30, 2023	SUPPL -15	View Letter (PDF)
Aug 15, 2017	SUPPL -13	View Letter (PDF)
Apr 3, 2017	SUPPL -9	View Letter (PDF)
Apr 3, 2017	SUPPL -10	View Letter (PDF)
Sep 25, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.03MG;0.15MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 5, 2003

No patent or exclusivity listings for this strength.