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Last Updated: June 10, 2024

LEVONORGESTREL - Generic Drug Details

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What are the generic sources for levonorgestrel and what is the scope of patent protection?

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-five 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:	35
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	250
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

Drug Sales Revenue Trends for LEVONORGESTREL

See drug sales revenues for LEVONORGESTREL

Recent Clinical Trials for LEVONORGESTREL

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

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
Washington University School of Medicine	Phase 2
Novo Nordisk A/S	Phase 2

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

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
Glenmark Pharms Ltd	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	207044-001	Mar 25, 2016		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Medicines360	LILETTA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bayer Hlthcare	SKYLA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Watson Labs	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	078666-001	Jun 24, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Naari Pte Ltd	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202380-001	May 29, 2015		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fdn Consumer	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	200670-001	Jul 12, 2012		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
Wyeth Pharms Inc	NORPLANT SYSTEM IN PLASTIC CONTAINER	levonorgestrel	IMPLANT;IMPLANTATION	020088-001	Dec 10, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	SKYLA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	203159-001	Jan 9, 2013	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225-001	Dec 6, 2000	⤷ Sign Up	⤷ Sign Up
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	KYLEENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	208224-001	Sep 16, 2016	⤷ 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
Norway	339210		⤷ Sign Up
Poland	2352470		⤷ Sign Up
Spain	2401551		⤷ Sign Up
Canada	2736020	DISPOSITIF D'INTRODUCTION (AN INSERTER)	⤷ Sign Up
Brazil	PI0612196	sistema intra-uterino ultra-sonicamente detectável, e método para melhorar a visualização de um sistema intra-uterino	⤷ Sign Up
Denmark	2352470		⤷ 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	300814	Netherlands	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	39/2015	Austria	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 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	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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