Viewing data from:

BEYAZ

NDA

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM | N022532 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

Today

8617597

Feb. 8, 2030

11617751

Jul. 17, 2030

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

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$8.29

per ea

Lowest NADAC/Unit

$1.56

per ea

Brand NDCs

Generic NDCs

Avg Brand: $8.29

Avg Generic: $1.56

81% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50419040703BEYAZ 28 TABLET	$8.29	EA	Brand	$1.56	2026-06-17
00781407515DROSP-EE-LEVOMEF 3-0.02-0.451	$1.56	EA	Generic	—	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 | 3 NDCs (2 FSS, 1 Big4)

Lowest Price

$65.22

Highest Price

$702.95

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00781-4075-15DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE	$65.22	FSS	Sandoz, Inc.	08/14/2028
50419-0407-03BEYAZ TABLETS	$702.95	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0407-03BEYAZ TABLETS	$544.78	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 Beyaz (2024)

Total Spending

$22K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$8.17

Spending Trend

$41K(2019)→$38K(2020)→$33K(2021)→$40K(2022)→$32K(2023)→$22K(2024)

YoY Change:-4.2%

5yr CAGR:+0.8%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
May 22, 2023	SUPPL -10	View Letter (PDF)
May 3, 2022	SUPPL -11	View Letter (PDF)
Aug 15, 2017	SUPPL -9	View Letter (PDF)
Jun 3, 2015	SUPPL -6	View Letter (PDF)
Apr 12, 2012	SUPPL -4	View Letter (PDF)
Feb 21, 2012	SUPPL -1	View Letter (PDF)
Sep 29, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG

RLDAB

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 24, 2010

Patents (2) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8617597	Feb 8, 2030	—	—	Yes	—	—
11617751	Jul 17, 2030	—	—	Yes		—