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Last Updated: March 28, 2024

KYLEENA Drug Patent 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 five patents protecting this drug.

This drug has seventy-seven patent family members in thirty countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Kyleena

A generic version of KYLEENA was approved as levonorgestrel by NOVEL LABS INC on February 22nd, 2013.

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Summary for KYLEENA
Drug patent expirations by year for KYLEENA
Drug Prices for KYLEENA

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Recent Clinical Trials for KYLEENA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Arkansas Children's Hospital Research InstitutePhase 4
Science Valley Research InstitutePhase 2
Biós FarmacêuticaPhase 2

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Pharmacology for KYLEENA

US Patents and Regulatory Information for KYLEENA

KYLEENA is protected by five US patents.

Patents protecting KYLEENA

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Patented Use: A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS

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Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inserter
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM

Inserter
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a 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 93156 Luxembourg ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.