Viewing data from:

SAFYRAL

NDA

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM | N022574 | 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 | 1 NDC

Highest NADAC/Unit

$3.18

per ea

Lowest NADAC/Unit

$3.18

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00781410315DROSP-EE-LEVOMEF 3-0.03-0.451	$3.18	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

$47.67

Highest Price

$578.64

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00781-4103-15DROSPIRENONE-E.ESTRADIOL-LM.FA	$47.67	FSS	Sandoz, Inc.	08/14/2028
50419-0403-03SAFYRAL TABLETS	$578.64	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0403-03SAFYRAL TABLETS	$448.72	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 Safyral (2024)

Total Spending

$6K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$6.95

Spending Trend

$5K(2019)→$3K(2020)→$3K(2021)→$8K(2023)→$6K(2024)

YoY Change:-9.9%

5yr CAGR:-1.0%

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)
Dec 21, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG

RLDAB

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 16, 2010

Patents (2) · 2 use codes

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