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Serving leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Chinese Patent Office
Colorcon
Cerilliant
AstraZeneca
Harvard Business School
Moodys
US Department of Justice
QuintilesIMS

Generated: December 16, 2017

DrugPatentWatch Database Preview

KYLEENA Drug Profile

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Which patents cover Kyleena, and when can generic versions of Kyleena launch?

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

This drug has seventy-seven patent family members in twenty-eight countries and five supplementary protection certificates in five countries.

The generic ingredient in KYLEENA is levonorgestrel. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Drug patent expirations by year for KYLEENA

Pharmacology for KYLEENA

Medical Subject Heading (MeSH) Categories for KYLEENA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer HlthcareKYLEENAlevonorgestrelINTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Bayer HlthcareKYLEENAlevonorgestrelINTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Bayer HlthcareKYLEENAlevonorgestrelINTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Bayer HlthcareKYLEENAlevonorgestrelINTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Tradename: KYLEENA

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: KYLEENA

Country Document Number Estimated Expiration
Germany60319549► Subscribe
Russian Federation2011114979► Subscribe
Costa Rica7709► Subscribe
Japan5390618► Subscribe
China1310627► Subscribe
Portugal1539063► Subscribe
China1681455► Subscribe
Denmark2352470► Subscribe
South Korea20050057381► Subscribe
Canada2735952► 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: KYLEENA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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:

Cantor Fitzgerald
Fish and Richardson
Novartis
Federal Trade Commission
Citi
Teva
Colorcon
Covington
McKinsey
Fuji

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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