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 Neuvosyn Laboratories, LLC submitted an ANDA Suitability Petition on June 29, 2026, requesting a determination that norethindrone acetate 1 mg and ethinyl estradiol 15 mcg capsules combined with ferrous fumarate 75 mg capsules are suitable for submission in an abbreviated new drug application under	Suitability	2026-06-30	Open	Neuvosyn Laboratories

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Taytulla (2023)

Total Spending

$30K

Total Claims

Beneficiaries

Avg Cost/Unit

$8.68

Spending Trend

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

YoY Change:+8.3%

5yr CAGR:+6.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

5 letters from Drugs@FDA

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.