KYLEENA Drug Patent Profile

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-nine patent family members in twenty-eight countries.

The generic ingredient in KYLEENA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-three 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.

Summary for KYLEENA

International Patents:	79
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	3
Patent Applications:	3,959
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

See drug prices 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
Biós Farmacêutica	Phase 2
Science Valley Research Institute	Phase 2

See all KYLEENA clinical trials

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 five US patents.

Patents protecting 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			Y
Bayer Hlthcare	KYLEENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes			Y
Bayer Hlthcare	KYLEENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes
Bayer Hlthcare	KYLEENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes			Y

International Patents for KYLEENA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0314287	processo de manufatura de um sistema de distribuição
Norway	331466
China	102159160	Inserter
South Korea	20110083598	AN INSERTER

Supplementary Protection Certificates for KYLEENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	C201630040	Spain		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	15C0050	France		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		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211