Levonorgestrel - Generic Drug Details

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 Ltd, Novast Labs, Alvogen, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Mylan Labs Ltd, Naari Pte Ltd, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, and Sun Pharm, and is included in thirty NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levonorgestrel has one hundred and ten patent family members in thirty-five countries.

There are twenty drug master file entries for levonorgestrel. Thirty-four suppliers are listed for this compound.

Summary for levonorgestrel

International Patents:	110
US Patents:	6
Tradenames:	14
Applicants:	20
NDAs:	30
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	248
Patent Applications:	5,759
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for levonorgestrel
What excipients (inactive ingredients) are in levonorgestrel?	levonorgestrel excipients list
DailyMed Link:	levonorgestrel at DailyMed

See drug prices for levonorgestrel

See drug sales revenues for levonorgestrel

Recent Clinical Trials for levonorgestrel

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

Sponsor	Phase
Washington University School of Medicine	Phase 2
Novo Nordisk A/S	Phase 2
Arkansas Children's Hospital Research Institute	Phase 4

See all levonorgestrel clinical trials

Pharmacology for levonorgestrel

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

Medical Subject Heading (MeSH) Categories for levonorgestrel

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Anatomical Therapeutic Chemical (ATC) Classes for levonorgestrel

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 levonorgestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Naari Pte Ltd	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202380-001	May 29, 2015		OTC	No	No
Alvogen	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202246-001	Jun 5, 2015		DISCN	No	No
Medicines360	LILETTA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes			Y
Sun Pharm	OPCICON ONE-STEP	levonorgestrel	TABLET;ORAL	202635-001	Sep 11, 2014		OTC	No	No
Perrigo R And D	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202334-001	Aug 20, 2014		OTC	No	No
Bayer Hlthcare	SKYLA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes			Y

Expired US Patents for levonorgestrel

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

International Patents for levonorgestrel

Country	Patent Number	Title	Estimated Expiration
Finland	20050345	Ultraäänellä havaittavissa oleva kondunsisäinen laite ja menetelmä ultraäänidetektion tehostamiseksi;Med ultraljud detekterbar intrauterin anordning och förfarande för effektivering av ultraljudsdetektering
Japan	2021518216	子宮内器具（ＩＵＤ）挿入装置および関連する方法とそのためのキット
Japan	5264475
South Korea	20070120542	AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM AND A METHOD FOR ENHANCING ULTRASOUND DETECTION
European Patent Office	1871314	SYSTEME INTRA-UTERIN DETECTABLE PAR ULTRASONS (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM)
New Zealand	619783	Intrauterine systems, iud insertion devices, and related methods and kits therefor

Supplementary Protection Certificates for levonorgestrel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
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	39/2015	Austria		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	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211