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KYLEENA Drug Profile

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Which patents cover Kyleena, and what substitute generic drugs are available?

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

This drug has thirty 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-nine suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

Summary for Tradename: KYLEENA

Patents:1
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 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, 2016RXYesYes► Subscribe► Subscribe
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International Patent Family for Tradename: KYLEENA

Country Document Number Estimated Expiration
Slovenia1539063► Subscribe
MexicoPA05002718► Subscribe
Denmark1539063► Subscribe
Australia2003258752► Subscribe
New Zealand538275► 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
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
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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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