kyleena Drug Patent Profile

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When do Kyleena patents expire, 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-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 22^nd, 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:	4,778
Formulation / Manufacturing:	see details
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

Recent Clinical Trials for kyleena

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

Sponsor	Phase
Arkansas Children's Hospital Research Institute	Phase 4
Science Valley Research Institute	Phase 2
Biós Farmacêutica	Phase 2

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Pharmacology for kyleena

Drug Class	Progestin Progestin-containing Intrauterine Device
Physiological Effect	Inhibit Ovum Fertilization

Anatomical Therapeutic Chemical (ATC) Classes for kyleena

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03AD	Emergency contraceptives
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for kyleena

kyleena is protected by three US patents.

Patents protecting kyleena

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

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

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Glossary

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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				⤷ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for kyleena

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	KYLEENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	208224-001	Sep 16, 2016	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for kyleena

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

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Country	Patent Number	Title	Estimated Expiration
New Zealand	538275	A delivery system and a manufacturing process of a delivery system	⤷ Try a Trial
European Patent Office	2349143	DISPOSITIF D'INTRODUCTION (AN INSERTER)	⤷ Try a Trial
Poland	2352470		⤷ Try a Trial
Israel	166787	DELIVERY SYSTEM AND MANUFACTURING PROCESS OF A DELIVERY SYSTEM	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for kyleena

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	39/2015	Austria	⤷ Try a 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	122015000093	Germany	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	93156	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	C 2015 029	Romania	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for kyleena

Recent Clinical Trials for kyleena

Pharmacology for kyleena

Anatomical Therapeutic Chemical (ATC) Classes for kyleena

Patents protecting kyleena

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