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Last Updated: February 22, 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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levonorgestrel has one hundred and forty-four patent family members in thirty-seven countries.

There are twenty drug master file entries for levonorgestrel. Thirty-four suppliers are listed for this compound.

Summary for levonorgestrel
Drug Prices for levonorgestrel

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Drug Sales Revenue Trends for levonorgestrel

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Recent Clinical Trials for levonorgestrel

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SponsorPhase
Washington University School of MedicinePhase 2
Novo Nordisk A/SPhase 2
Arkansas Children's Hospital Research InstitutePhase 4

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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
Glenmark Pharms Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 207044-001 Mar 25, 2016 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D LEVONORGESTREL levonorgestrel TABLET;ORAL 202334-001 Aug 20, 2014 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wyeth Pharms Inc NORPLANT SYSTEM IN PLASTIC CONTAINER levonorgestrel IMPLANT;IMPLANTATION 020088-001 Dec 10, 1990 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lotus Pharm Co Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 202684-001 Sep 2, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma ATHENTIA NEXT levonorgestrel TABLET;ORAL 206867-001 Dec 8, 2015 OTC 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
Alvogen LEVONORGESTREL levonorgestrel TABLET;ORAL 202246-001 Jun 5, 2015 DISCN No No ⤷  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

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

International Patents for levonorgestrel

Country Patent Number Title Estimated Expiration
Ukraine 112315 ВНУТРІШНЬОМАТКОВІ СИСТЕМИ, ПРИСТРОЇ ВВЕДЕННЯ ПРИСТРОЇВ IUD (ВНУТРІШНЬОМАТКОВИХ ПРИСТРОЇВ) І ПОВ'ЯЗАНІ З НИМИ СПОСОБИ І НАБОРИ ⤷  Try a Trial
Canada 2736020 DISPOSITIF D'INTRODUCTION (AN INSERTER) ⤷  Try a Trial
China 102159160 Inserter ⤷  Try a Trial
Hong Kong 1076023 A delivery system and a manufacturingprocess of a system ⤷  Try a Trial
Israel 211058 מחדיר (Inserter for ius) ⤷  Try a Trial
Canada 2607079 SYSTEME INTRA-UTERIN DETECTABLE PAR ULTRASONS ET PROCEDE DESTINE A INTENSIFIER LA DETECTION PAR LES ULTRASONS (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM AND A METHOD FOR ENHANCING ULTRASOUND DETECTION) ⤷  Try a Trial
Brazil 0314287 Sistema de distribuição e processo de manufatura do mesmo ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for levonorgestrel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 300814 Netherlands ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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 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 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 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
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 C 2015 029 Romania ⤷  Try a Trial 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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