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Last Updated: April 26, 2024

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, 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

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
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

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
Mylan Labs Ltd	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202740-001	Sep 2, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Population Council	JADELLE	levonorgestrel	IMPLANT;IMPLANTATION	020544-001	Nov 1, 1996		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bayer Hlthcare	MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225-001	Dec 6, 2000		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Alvogen	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202246-001	Jun 5, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bayer Hlthcare	SKYLA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Bayer Hlthcare	SKYLA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
Bayer Hlthcare	SKYLA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	203159-001	Jan 9, 2013	⤷ Try a Trial	⤷ Try a Trial
Bayer Hlthcare	MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225-001	Dec 6, 2000	⤷ Try a Trial	⤷ Try a Trial
Wyeth Pharms Inc	NORPLANT SYSTEM IN PLASTIC CONTAINER	levonorgestrel	IMPLANT;IMPLANTATION	020088-001	Dec 10, 1990	⤷ Try a Trial	⤷ Try a Trial
Bayer Hlthcare	KYLEENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	208224-001	Sep 16, 2016	⤷ Try a Trial	⤷ Try a Trial
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990	⤷ Try a Trial	⤷ Try a Trial
Bayer Hlthcare	SKYLA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	203159-001	Jan 9, 2013	⤷ Try a Trial	⤷ Try a Trial
>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
Russian Federation	2011115057	УСТРОЙСТВО ДЛЯ ВВЕДЕНИЯ	⤷ Try a Trial
South Korea	101604507		⤷ Try a Trial
Mexico	2014000405	SISTEMAS INTRAUTERINOS, DISPOSITIVOS DE INSERCION DIU, Y METODOS RELACIONADOS Y KITS DE LOS MISMOS. (INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR.)	⤷ Try a Trial
South Korea	20070120542	AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM AND A METHOD FOR ENHANCING ULTRASOUND DETECTION	⤷ Try a Trial
Croatia	P20181826		⤷ Try a Trial
Japan	7392929		⤷ Try a Trial
>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	122015000093	Germany	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	15C0050	France	⤷ Try a Trial	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	39/2015	Austria	⤷ Try a Trial	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	132016000025143	Italy	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	CA 2016 00016	Denmark	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	C201630040	Spain	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.