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Last Updated: June 18, 2021

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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 Ltd, 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levonorgestrel has one hundred and two patent family members in thirty-three countries.

There are twenty drug master file entries for levonorgestrel. Twenty-one suppliers are listed for this compound.

Drug Prices for levonorgestrel

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Drug Sales Revenue Trends for levonorgestrel

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Recent Clinical Trials for levonorgestrel

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

SponsorPhase
University of LiverpoolPhase 4
National Cancer Institute (NCI)Phase 3
Botswana Harvard AIDS Institute PartnershipPhase 4

See all levonorgestrel clinical trials

Pharmacology for levonorgestrel
Medical Subject Heading (MeSH) Categories for levonorgestrel

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 207660-001 May 2, 2019 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Fdn Consumer LEVONORGESTREL levonorgestrel TABLET;ORAL 200670-001 Jul 12, 2012 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Population Council NORPLANT levonorgestrel IMPLANT;IMPLANTATION 019897-001 Dec 10, 1990 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Fdn Consumer PLAN B levonorgestrel TABLET;ORAL 021045-001 Jul 28, 1999 DISCN Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Mylan Labs Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 202740-001 Sep 2, 2016 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Population Council JADELLE levonorgestrel IMPLANT;IMPLANTATION 020544-001 Nov 1, 1996 DISCN Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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

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

International Patents for levonorgestrel

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2010031902   Try Before You Buy
Israel 211059   Try Before You Buy
World Intellectual Property Organization (WIPO) 2010031900   Try Before You Buy
Poland 2349143   Try Before You Buy
Poland 374112   Try Before You Buy
Mexico 2011002671   Try Before You Buy
Spain 2401551   Try Before You Buy
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for levonorgestrel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 C201630040 Spain   Try Before You Buy 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 93156 Luxembourg   Try Before You Buy PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 122015000093 Germany   Try Before You Buy 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 Before You Buy 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 Before You Buy 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 300814 Netherlands   Try Before You Buy PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 C 2015 029 Romania   Try Before You Buy 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
>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.