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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Covington
Novartis
US Army
Cantor Fitzgerald
Chubb
Queensland Health
Moodys
Argus Health
Johnson and Johnson

Generated: June 24, 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 two patents protecting this drug.

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

The generic ingredient in KYLEENA 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: KYLEENA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list44
Patent Applications: see list3,776
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:KYLEENA at DailyMed

Pharmacology for Tradename: KYLEENA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
KYLEENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes7,252,839► SubscribeY ► Subscribe
Bayer Hlthcare
KYLEENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes9,615,965► SubscribeY ► Subscribe
Bayer Hlthcare
KYLEENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes► Subscribe► 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
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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
South Africa201100900► Subscribe
Japan2005538791► Subscribe
EcuadorSP055686► Subscribe
Australia2009294545► 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
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
/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
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
Healthtrust
Moodys
Citi
Covington
Queensland Health
UBS
Chubb
Cipla

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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