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Last Updated: November 2, 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 three 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-five 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
International Patents:77
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 104
Clinical Trials: 3
Patent Applications: 4,733
Drug Prices: Drug price information for KYLEENA
What excipients (inactive ingredients) are in KYLEENA?KYLEENA excipients list
DailyMed Link:KYLEENA at DailyMed
Drug patent expirations by year for KYLEENA
Drug Prices for KYLEENA

See drug prices for KYLEENA

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

See all KYLEENA clinical trials

Pharmacology for KYLEENA

US Patents and Regulatory Information for KYLEENA

KYLEENA is protected by three US patents.

Patents protecting KYLEENA

Inserter
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF PREVENTING PREGNANCY BY PROVIDING AN INTRAUTERINE SYSTEM (IUS), HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND MOVING A SLIDER IN THE HANDLE TO RELEASE THE IUS WITHIN THE UTERUS

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 SYSTEM;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bayer Hlthcare KYLEENA levonorgestrel SYSTEM;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare KYLEENA levonorgestrel SYSTEM;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for KYLEENA

See the table below for patents covering KYLEENA around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2297810 СИСТЕМА ДОСТАВКИ И СПОСОБ ПРОИЗВОДСТВА СИСТЕМЫ ДОСТАВКИ (DELIVERY SYSTEM AND METHOD FOR PRODUCING THE SYSTEM) ⤷  Sign Up
Norway 331466 ⤷  Sign Up
European Patent Office 1871314 SYSTEME INTRA-UTERIN DETECTABLE PAR ULTRASONS (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM) ⤷  Sign Up
Spain 2424984 ⤷  Sign Up
Hong Kong 1155351 AN INSERTER ⤷  Sign Up
Australia 2009294543 An inserter ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KYLEENA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 C 2015 029 Romania ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521 132016000025143 Italy ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521 CA 2016 00016 Denmark ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 15C0050 France ⤷  Sign Up 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 C201630040 Spain ⤷  Sign Up PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521 93156 Luxembourg ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 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.