Viewing data from:

TAYTULLA

NDA

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | N204426 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD

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

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

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Neuvosyn Laboratories, LLC FDA-2026-P-7276 · 5 docket documents Neuvosyn Laboratories, LLC submitted an ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare norethindrone acetate 1 mg / ethinyl estradiol 15 mcg capsules and ferrous fumarate 75 mg capsules suitable for submission in	Suitability	2026-06-30	Open	Neuvosyn Laboratories, LLC

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

Clinical Trials

17 trials from ClinicalTrials.gov, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism NCT00004763	Phase 2	Completed	National Center for Research Resources (NCRR)	45	1993-01
A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists NCT01209143	Phase 1	Completed	Genentech, Inc.	52	2010-11 → 2012-03
Ovulation Incidence in Oral Contraceptive Users NCT03106454	Phase 3	Completed	University of Southern California	58	2014-08 → 2024-01-01
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions NCT01340625	Phase 1	Completed	Teva Pharmaceuticals USA	36	2006-12 → 2007-01
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive NCT01040845	Phase 1	Completed	Mutual Pharmaceutical Company, Inc.	30	2007-08 → 2008-02
Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325 NCT02103569	Phase 1	Completed	Bristol-Myers Squibb	20	2014-04 → 2014-07
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions NCT01344369	Phase 1	Completed	Teva Pharmaceuticals USA	36	2008-08 → 2008-09
Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.NCT00212277	Phase 3	Completed	Nobelpharma	—	2005-02 → 2007-02
Study of Bleeding With Extended Administration of an Oral Contraceptive NCT00338052	Phase 2	Completed	Warner Chilcott	207	2006-06 → 2007-05
Study of Safety and Efficacy of an Oral Contraceptive NCT00477633	Phase 3	Completed	Warner Chilcott	1,700	2007-06 → 2009-02

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

$8.97

per ea

Lowest NADAC/Unit

$8.97

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00023586230TAYTULLA 1 MG-20 MCG CAPSULE	$8.97	EA	Brand	$0.6605	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

$907.10

Highest Price

$944.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00023-5862-30TAYTULLA CAP,28	$944.20	FSS	Abbvie US LLC	07/31/2030
00023-5862-30TAYTULLA CAP,28	$907.10	Big4	Abbvie US LLC	07/31/2030

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

Medicare Part D Spending

CMS annual spending data for Taytulla (2024)

Total Spending

$19K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$8.55

Spending Trend

$80K(2019)→$75K(2020)→$30K(2021)→$30K(2022)→$30K(2023)→$19K(2024)

YoY Change:-1.4%

5yr CAGR:+4.7%

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 27, 2023	SUPPL -9	View Letter (PDF)
May 3, 2022	SUPPL -10	View Letter (PDF)
Aug 21, 2017	SUPPL -7	View Letter (PDF)
Aug 19, 2016	SUPPL -4	View Letter (PDF)
Apr 24, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.02MG;1MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 19, 2013

No patent or exclusivity listings for this strength.