Levonorgestrel - Generic Drug Details

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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 Ltd, Novast Labs, Alvogen, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co 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 seven 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-five suppliers are listed for this compound.

Summary for levonorgestrel

International Patents:	110
US Patents:	7
Tradenames:	14
Applicants:	19
NDAs:	30
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	252
Patent Applications:	6,420
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

Drug Sales Revenue Trends for levonorgestrel

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Recent Clinical Trials for levonorgestrel

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

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
Lori Gawron	Phase 4
Planned Parenthood Association of Utah	Phase 4

See all levonorgestrel clinical trials

Pharmacology for levonorgestrel

Drug Class	Progestin Progestin-containing Intrauterine System Progestin-containing Intrauterine Device
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

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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
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		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				⤷ Sign Up
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Wyeth Pharms Inc	LEVONORGESTREL	levonorgestrel	IMPLANT;IMPLANTATION	020627-001	Aug 15, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 levonorgestrel

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

International Patents for levonorgestrel

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1871314	SYSTEME INTRA-UTERIN DETECTABLE PAR ULTRASONS (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM)	⤷ Sign Up
Argentina	075548	UN INSERTOR	⤷ Sign Up
Poland	2352470		⤷ Sign Up
South Korea	101604507		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006106180		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for levonorgestrel

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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	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	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	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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