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Last Updated: July 2, 2020

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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-eight patent family members in twenty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Kyleena

A generic version of KYLEENA was approved as levonorgestrel by L PERRIGO CO on December 30th, 2010.

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US Patents and Regulatory Information for 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;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for KYLEENA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 39/2015 Austria   Start Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 132016000025143 Italy   Start Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Johnson and Johnson
Merck
Mallinckrodt
McKinsey

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