Viewing data from:

TWIRLA

NDA

ETHINYL ESTRADIOL; LEVONORGESTREL | N204017 | AGILE THERAPEUTICS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

Today

8246978

Aug. 26, 2028

8747888

Jul. 10, 2028

9050348

Jul. 10, 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

No ANDA patent litigation cases (NOS 835) matched from PACER

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

$66.80

per ea

Lowest NADAC/Unit

$66.80

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
71671010003TWIRLA 120-30 MCG/DAY PATCH	$66.80	EA	Brand	—	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

$108.11

Highest Price

$137.19

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71671-0100-03TWIRLA	$137.19	FSS	Agile Therapeutics, Inc. dba Agile Therapeutics	09/14/2026
71671-0100-03TWIRLA	$108.11	Big4	Agile Therapeutics, Inc. dba Agile Therapeutics	09/14/2026

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -9	View Letter (PDF)
May 3, 2022	SUPPL -4	View Letter (PDF)
Feb 18, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.03MG/24HR;0.12MG/24HR

RLD

3 patents0 exclusivities▴

SYSTEM;TRANSDERMAL | Approved: Feb 14, 2020

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8246978	Aug 26, 2028	—	—	Yes	—	—
8747888	Jul 10, 2028	—	—	Yes	—	—
9050348	Jul 10, 2028	—	—	Yes	—	—