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YAZ

NDA

DROSPIRENONE; ETHINYL ESTRADIOL | N021676 | BAYER HEALTHCARE PHARMACEUTICALS 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer Schering Pharma AG et al v. Mylan Pharmaceuticals Inc. et al 2:2011cv00604 ANDA 202594drospirenone and ethinylestradiol (micronized drospirenone and micronized 17-ethinylestradiol)	D. Nev.	2011-04-19	Terminated 2014-01-02	—
Bayer Schering Pharma AG et al v. Teva Pharmaceuticals USA, Inc. et al 1:2010cv03697 1 patentdrospirenone and 17α-ethinylestradiol (stabilized by β-cyclodextrin)	N.D. Ill.	2010-06-15	Terminated 2010-06-29	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

15 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne NCT00722761	Phase 3	Completed	Massachusetts General Hospital	30	2009-04 → 2012-04
Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females NCT00745901	Phase 4	Completed	Ortho-McNeil Janssen Scientific Affairs, LLC	355	2008-05 → 2008-10
Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.NCT01182194	Phase 1	Completed	Teva Pharmaceuticals USA	32	2006-06 → 2006-08
Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.NCT01519401	N/A	Completed	Catholic University of the Sacred Heart	50	2010-02 → 2011-07
Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study NCT00640224	Phase 4	Completed	Silva Arslanian	65	2005-03 → 2015-07
Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance NCT01511822	Phase 4	Completed	AGUNCO Obstetrics and Gynecology Centre	—	—
The Oral Contraceptive Pill for Premenstrual Worsening of Depression NCT00633360	N/A	Completed	Massachusetts General Hospital	32	2008-02 → 2011-05
Metabolic Syndrome in PCOS: Precursors and Interventions NCT00442689	N/A	Completed	Northwestern University	97	2006-07 → 2012-11
LCS16 vs. COC User Satisfaction and Tolerability Study NCT03074045	Phase 3	Completed	Bayer	145	2017-03-13 → 2022-08-05
Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions NCT01182207	Phase 1	Completed	Teva Pharmaceuticals USA	33	2006-07 → 2006-08

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

$5.85

per ea

Lowest NADAC/Unit

$5.85

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50419040503YAZ 28 TABLET	$5.85	EA	Brand	$0.1895	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

$384.15

Highest Price

$496.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50419-0405-03YAZ 3MG/0.02MG TAB,28	$496.20	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0405-03YAZ 3MG/0.02MG TAB,28	$384.15	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026

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

Medicare Part D Spending

CMS annual spending data for Yaz (2024)

Total Spending

$101K

Total Claims

288

Beneficiaries

Avg Cost/Unit

$5.89

Spending Trend

$101K(2019)→$102K(2020)→$117K(2021)→$112K(2022)→$114K(2023)→$101K(2024)

YoY Change:-8.9%

5yr CAGR:+2.1%

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
May 22, 2023	SUPPL -20	View Letter (PDF)
May 3, 2022	SUPPL -21	View Letter (PDF)
Aug 15, 2017	SUPPL -19	View Letter (PDF)
Jun 3, 2015	SUPPL -14	View Letter (PDF)
Apr 12, 2012	SUPPL -12	View Letter (PDF)
Mar 16, 2011	SUPPL -8	View Letter (PDF)
Apr 12, 2010	SUPPL -9	View Letter (PDF)
Feb 2, 2007	SUPPL -2	View Letter (PDF)
Mar 23, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG;0.02MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 16, 2006

No patent or exclusivity listings for this strength.