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Serving leading biopharmaceutical companies globally:

UBS
Harvard Business School
Colorcon
Merck
Fish and Richardson
US Army
Moodys
Chinese Patent Office
Cerilliant
Accenture

Generated: December 11, 2017

DrugPatentWatch Database Preview

MIRENA Drug Profile

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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 two patents protecting this drug.

This drug has forty-four patent family members in twenty countries and five supplementary protection certificates in five 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bayer HlthcareMIRENAlevonorgestrelINTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 2000RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareMIRENAlevonorgestrelINTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 2000RXYesYes► Subscribe► Subscribe► SubscribeY► 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
D791318Inserter► 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
Japan2012502713► Subscribe
South Africa201100900► Subscribe
Portugal2349143► Subscribe
Australia2009294545► Subscribe
Japan2012502712► Subscribe
Russian Federation2494706► Subscribe
European Patent Office2349143► Subscribe
Taiwan201021775► Subscribe
Poland2349143► Subscribe
South Korea20110074741► 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
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
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 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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Serving leading biopharmaceutical companies globally:

Fuji
Covington
Cipla
US Army
Johnson and Johnson
Daiichi Sankyo
QuintilesIMS
Boehringer Ingelheim
McKinsey
Argus Health

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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