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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Daiichi Sankyo
Citi
Queensland Health
Covington
Fuji
US Department of Justice
Chubb
Julphar

Generated: July 21, 2017

DrugPatentWatch Database Preview

MIRENA Drug Profile

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

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

This drug has eighteen patent family members in eighteen countries.

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

Summary for Tradename: MIRENA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list44
Clinical Trials: see list50
Patent Applications: see list3,319
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MIRENA at DailyMed

Pharmacology for Tradename: MIRENA

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;INTRAUTERINE021225-001Dec 6, 2000RXYesYes9,668,912► SubscribeY ► Subscribe
Bayer Hlthcare
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 2000RXYesYes9,615,965► SubscribeY ► Subscribe
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Expired Patents for Tradename: MIRENA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 20005,785,053► Subscribe
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Non-Orange Book Patents for Tradename: MIRENA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,452,082Inserter► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: MIRENA

Country Document Number Estimated Expiration
Israel211058► Subscribe
Russian Federation2494706► Subscribe
Denmark2349143► Subscribe
South Africa201100900► Subscribe
Spain2424984► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MIRENA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
Fish and Richardson
Covington
Chinese Patent Office
Merck
Cantor Fitzgerald
Accenture
QuintilesIMS
Fuji
Johnson and Johnson

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 verifification 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.

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