Viewing data from:

CLIMARA PRO

NDA

ESTRADIOL; LEVONORGESTREL | N021258 | 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

46 trials from ClinicalTrials.gov — 1 recruiting, 39 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies NCT03557619	Phase 1	Recruiting	AbbVie	12	2019-07-30 → 2026-03-21
Managing Temporomandibular Disorder (TMD) Symptoms NCT00237042	N/A	Completed	University of Washington	252	2005-10 → 2010-06
Hormonal Birth Control and the Risk of Acquiring HIV NCT00006324	N/A	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	6,360	1999-12 → 2002-12
The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females NCT00254800	Phase 1	Completed	AstraZeneca	38	2005-11 → 2006-08
Oral Contraceptive Efficacy and Body Weight NCT00662454	Phase 4	Completed	Oregon Health and Science University	120	2006-01 → 2006-05
A Study in Healthy Participants to Evaluate the Effects of Multiple Doses of JNJ-55308942 on Cytochrome P450 Substrate Activity and on the Pharmacokinetics of Levonorgestrel/Ethinyl Estradiol NCT03547024	Phase 1	Completed	Janssen-Cilag International NV	14	2018-06-08 → 2018-08-30
Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel NCT03359057	Phase 3	Completed	Galeno Desenvolvimento de Pesquisas Clínicas	36	2013-02-26 → 2013-09-17
Human Ovarian Follicular Dynamics and Emergency Contraception NCT00204451	Phase 4	Completed	University of Saskatchewan	40	2005-07 → 2006-06
Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive NCT00213096	Phase 2	Completed	Population Council	50	2003-03 → 2004-02
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids NCT04267250	Phase 1	Completed	Pfizer	18	2020-08-24 → 2020-11-06

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

$59.69

per ea

Lowest NADAC/Unit

$59.69

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50419049104CLIMARA PRO PATCH	$59.69	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$186.89

Highest Price

$241.05

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50419-0491-04CLIMARA PRO 0.045MG/0.015MG/DAY PATCH	$241.05	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0491-04CLIMARA PRO 0.045MG/0.015MG/DAY PATCH	$186.89	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 Climara Pro (2024)

Total Spending

$3.7M

Total Claims

8,334

Beneficiaries

2,248

Avg Cost/Unit

$61.16

Spending Trend

$3.0M(2019)→$3.3M(2020)→$3.4M(2021)→$3.5M(2022)→$3.6M(2023)→$3.7M(2024)

YoY Change:-3.8%

5yr CAGR:+2.5%

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 16, 2021	SUPPL -12	View Letter (PDF)
Oct 12, 2021	SUPPL -13	View Letter (PDF)
Oct 11, 2013	SUPPL -6	View Letter (PDF)
Jun 24, 2005	SUPPL -3	View Letter (PDF)
Nov 28, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.045MG/24HR;0.015MG/24HR

RLD

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Nov 21, 2003

No patent or exclusivity listings for this strength.