You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Dow
Medtronic
AstraZeneca
McKesson
Baxter
Moodys

Last Updated: September 27, 2023

MIRENA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Mirena, and what generic alternatives are available?

Mirena is a drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this drug.

This drug has forty-five patent family members in twenty countries.

The generic ingredient in MIRENA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mirena

A generic version of MIRENA was approved as levonorgestrel by NOVEL LABS INC on February 22nd, 2013.

  Try a Trial

Drug patent expirations by year for MIRENA
Drug Prices for MIRENA

See drug prices for MIRENA

Drug Sales Revenue Trends for MIRENA

See drug sales revenues for MIRENA

Recent Clinical Trials for MIRENA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Arkansas Children's Hospital Research InstitutePhase 4
Boston Children's HospitalPhase 2
Eastern Virginia Medical SchoolPhase 4

See all MIRENA clinical trials

Pharmacology for MIRENA

US Patents and Regulatory Information for MIRENA

MIRENA is protected by four US patents and one FDA Regulatory Exclusivity.

Patents protecting MIRENA

Inserter
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS

Inserter
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inserter
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM

Inserter
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting MIRENA

DOSING REGIMEN EXTENDING THE CONTRACEPTION USE FROM 5 YEARS TO UP TO 6 YEARS
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for MIRENA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 15C0050 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 122015000093 Germany ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 39/2015 Austria ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 C 2015 029 Romania ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521 132016000025143 Italy ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
AstraZeneca
Johnson and Johnson
Medtronic
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.