levonorgestrel - Profile

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What are the generic drug sources for levonorgestrel and what is the scope of freedom to operate?

Levonorgestrel is the generic ingredient in fourteen branded drugs marketed by Population Council, Wyeth Pharms Inc, Bayer Hlthcare, Medicines360, Aurobindo Pharma, Lupin, Novast Labs, Alvogen, Annora Pharma, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Lupin Ltd, Naari Pte, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, and Sun Pharm, and is included in thirty-one NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for levonorgestrel

International Patents:	113
US Patents:	7
Tradenames:	14
Applicants:	21
NDAs:	31

US Patents and Regulatory Information for levonorgestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Population Council	JADELLE	levonorgestrel	IMPLANT;IMPLANTATION	020544-001	Nov 1, 1996		DISCN	Yes	No
Wyeth Pharms Inc	LEVONORGESTREL	levonorgestrel	IMPLANT;IMPLANTATION	020627-001	Aug 15, 1996		DISCN	No	No
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990		DISCN	No	No
Wyeth Pharms Inc	NORPLANT SYSTEM IN PLASTIC CONTAINER	levonorgestrel	IMPLANT;IMPLANTATION	020088-001	Dec 10, 1990		DISCN	No	No
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes			Y
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016		RX	Yes	Yes			Y

Expired US Patents for levonorgestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MIRENA	levonorgestrel	SYSTEM;INTRAUTERINE	021225-001	Dec 6, 2000
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013
Wyeth Pharms Inc	NORPLANT SYSTEM IN PLASTIC CONTAINER	levonorgestrel	IMPLANT;IMPLANTATION	020088-001	Dec 10, 1990
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013

International Patents for levonorgestrel

Country	Patent Number	Title	Estimated Expiration
Australia	2012282832
Australia	2015221468
Brazil	112014000440
Brazil	122015016218
Canada	2841855
Canada	3099636
Chile	2014000080

Supplementary Protection Certificates for levonorgestrel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C 2015 029	Romania		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	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
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	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