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Last Updated: September 25, 2022

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

Levonorgestrel has one hundred and three 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
UNC Lineberger Comprehensive Cancer CenterPhase 2
Radiological Society of North AmericaPhase 2
ParexelPhase 1

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
Novast Labs HER STYLE levonorgestrel TABLET;ORAL 207976-001 Mar 11, 2016 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alvogen LEVONORGESTREL levonorgestrel TABLET;ORAL 202246-001 Jun 5, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Watson Labs LEVONORGESTREL levonorgestrel TABLET;ORAL 078666-001 Jun 24, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wyeth Pharms Inc NORPLANT SYSTEM IN PLASTIC CONTAINER levonorgestrel IMPLANT;IMPLANTATION 020088-001 Dec 10, 1990 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 091328-001 Jan 23, 2013 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000 See Plans and Pricing See Plans and Pricing
Wyeth Pharms Inc NORPLANT SYSTEM IN PLASTIC CONTAINER levonorgestrel IMPLANT;IMPLANTATION 020088-001 Dec 10, 1990 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159-001 Jan 9, 2013 See Plans and Pricing See Plans and Pricing
Population Council NORPLANT levonorgestrel IMPLANT;IMPLANTATION 019897-001 Dec 10, 1990 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for levonorgestrel

Country Patent Number Title Estimated Expiration
Denmark 2352470 See Plans and Pricing
Ukraine 77859 DELIVERY SYSTEM FOR CAPSULE CONTAINING PHARMACEUTICAL COMPOSITION, METHOD FOR MANUFACTURING THEREOF See Plans and Pricing
Portugal 1539063 See Plans and Pricing
Japan 2014523780 See Plans and Pricing
South Korea 20140051296 INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR See Plans and Pricing
Japan 5390618 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for levonorgestrel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 C 2015 029 Romania See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 C201630040 Spain See Plans and Pricing 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 CA 2016 00016 Denmark See Plans and Pricing PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 15C0050 France See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 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.