Viewing data from:

ANGELIQ

NDA

DROSPIRENONE; ESTRADIOL | N021355 | BAYER HEALTHCARE PHARMACEUTICALS INC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

Today

8906890

Oct. 22, 2031

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

18 trials from ClinicalTrials.gov, 13 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
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
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 Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function NCT01109979	Phase 4	Completed	Brigham and Women's Hospital	24	2009-12 → 2016-06
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

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$6.37

per ea

Lowest NADAC/Unit

$6.37

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50419048303ANGELIQ 0.5 MG-1 MG TABLET	$6.37	EA	Brand	—	2026-06-17
50419048203ANGELIQ 0.25 MG-0.5 MG TABLET	$6.37	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$417.88

Highest Price

$539.10

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50419-0482-03ANGELIQ 0.25/0.5 MG TAB,28	$539.10	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0482-03ANGELIQ 0.25/0.5 MG TAB,28	$417.95	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0483-03ANGELIQ 0.5MG/1MG TAB	$539.10	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0483-03ANGELIQ 0.5MG/1MG TAB	$417.88	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 Angeliq (2024)

Total Spending

$404K

Total Claims

1,117

Beneficiaries

299

Avg Cost/Unit

$6.51

Spending Trend

$306K(2019)→$343K(2020)→$352K(2021)→$393K(2022)→$427K(2023)→$404K(2024)

YoY Change:-5.6%

5yr CAGR:-0.4%

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -12	View Letter (PDF)
Oct 3, 2023	SUPPL -9	View Letter (PDF)
Oct 3, 2023	SUPPL -10	View Letter (PDF)
Jul 11, 2019	SUPPL -8	View Letter (PDF)
Jul 9, 2015	SUPPL -6	View Letter (PDF)
Mar 2, 2012	SUPPL -2	View Letter (PDF)
Mar 2, 2012	SUPPL -3	View Letter (PDF)
Oct 20, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.25MG;0.5MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Feb 29, 2012

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8906890	Oct 22, 2031	—	—	Yes	—	—

#002 — 0.5MG;1MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2005