Viewing data from:

MIRENA

NDA

LEVONORGESTREL | N021225 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

Today

10561524

Sep. 16, 2029

11850182

Sep. 14, 2029

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Bayer HealthCare LLC FDA-2015-P-4600 · 3 docket documents Bayer HealthCare LLC filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refuse to approve any ANDA for a generic levonorgestrel-releasing intrauterine system (Mirena) unless the applicant establishes bioequivalence through appropriate cli	505(q)	2015-12-04	Open	Bayer HealthCare LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

167 trials from ClinicalTrials.gov — 1 recruiting, 4 active, 134 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer NCT00788671	Phase 2	Active	M.D. Anderson Cancer Center	69	2008-11-03 → 2027-11-30
Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer NCT02397083	Phase 2	Active	M.D. Anderson Cancer Center	102	2015-09-23 → 2026-09-30
A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception NCT04143659	Phase 1	Active	Premier Research	136	2020-03-03 → 2026-03-26
Improving the Treatment for Women With Early Stage Cancer of the Uterus NCT01686126	Phase 2	Active	Queensland Centre for Gynaecological Cancer	165	2012-12 → 2026-12
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
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
The Effectiveness of Lng IUD for Treatment of the Patient Undergone Conservative Surgery for Pelvic Endometriosis NCT00455845	Phase 3	Completed	Mahidol University	54	2007-04 → 2009-12
Oral Contraceptive Efficacy and Body Weight NCT00662454	Phase 4	Completed	Oregon Health and Science University	120	2006-01 → 2006-05
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women NCT01252186	Phase 2	Completed	Teva Women's Health	265	2010-11 → 2011-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$548.85

Highest Price

$548.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50419-0423-01MIRENA 20MCG/DAY INTRAUTERINE SYSTEM	$548.85	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0423-01MIRENA 20MCG/DAY INTRAUTERINE SYSTEM	$548.85	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 Mirena (2024)

Total Spending

$758K

Total Claims

664

Beneficiaries

660

Avg Cost/Unit

$1141.29

Spending Trend

$670K(2019)→$586K(2020)→$661K(2021)→$697K(2022)→$777K(2023)→$758K(2024)

YoY Change:-4.3%

5yr CAGR:+3.0%

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

API Supply Chain14 active DMFs8 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGLEVONORGESTREL

DMF 41781981

GEDEON RICHTER PLCLEVONORGESTREL, USP

DMF 88061990

INDUSTRIALE CHIMICA SRLLEVONORGESTREL USP

DMF 166962003

SCINOPHARM TAIWAN LTDLEVONORGESTREL USP

DMF 170672003

CIPLA LTDLEVONORGESTREL USP

DMF 215472008

FORMOSA LABORATORIES INCLEVONORGESTREL

DMF 216342008

LUPIN LTDLEVONORGESTREL USP

DMF 225082009

QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTDLEVONORGESTREL (MICRONIZED)

DMF 276922013

SYMBIOTEC PHARMALAB PRIVATE LTDLEVONORGESTREL EP/USP, MICRONIZED

DMF 278672014

STERLING CHEMICAL MALTA LTDLEVONORGESTREL

DMF 285022014

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDLEVONORGESTREL

DMF 330002022

HUNAN KYF PHARMACEUTICAL CO LTDLEVONORGESTREL

DMF 374432022

VALARY LAB PRIVATE LIMITEDLEVONORGESTREL

DMF 421412025

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDLEVONORGESTREL

DMF 428742025

BIOTEK INCInactiveLEVONORGESTREL MICROCAPSULES

DMF 51561983

LEIRAS PHARMACEUTICALSInactiveLEVONORGESTREL INTRAUTERINE DEVICE

DMF 61751986

BIOTEK INCInactiveLEVONORGESTREL MICROCAPSULES

DMF 62251986

YANGZHOU PHARMACEUTICAL FACTORYInactiveLEVONORGESTREL USP 23

DMF 129341998

HUBEI PHARMACEUTICAL FACTORYInactiveLEVONORGESTREL, USP

DMF 129941998

HOECHST MARION ROUSSELInactiveLEVONORGESTREL

DMF 142881999

BAYER PHARMA AGInactiveLEVONORGESTREL (DCM)

DMF 184032005

INDO PHYTO CHEMICALS PRIVATE LTDInactiveLEVONORGESTREL USP

DMF 260642012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Aug 15, 2022	SUPPL -43	View Letter (PDF)
Aug 12, 2021	SUPPL -42	View Letter (PDF)
Jun 9, 2021	SUPPL -36	View Letter (PDF)
May 27, 2021	SUPPL -41	View Letter (PDF)
Aug 21, 2020	SUPPL -40	View Letter (PDF)
Jun 9, 2017	SUPPL -38	View Letter (PDF)
May 30, 2017	SUPPL -39	View Letter (PDF)
Dec 23, 2016	SUPPL -37	View Letter (PDF)
Oct 26, 2015	SUPPL -31	View Letter (PDF)
Aug 8, 2013	SUPPL -32	View Letter (PDF)
Nov 10, 2009	SUPPL -27	View Letter (PDF)
Jul 24, 2008	SUPPL -19	View Letter (PDF)
Jun 6, 2008	SUPPL -18	View Letter (PDF)
May 30, 2008	SUPPL -17	View Letter (PDF)
Jan 14, 2004	SUPPL -9	View Letter (PDF)
Aug 29, 2003	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 52MG

RLD

2 patents0 exclusivities▴

SYSTEM;INTRAUTERINE | Approved: Dec 6, 2000

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10561524	Sep 16, 2029	—	—	—		—
11850182	Sep 14, 2029	—	—	Yes		—