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Last Updated: August 13, 2020

DrugPatentWatch Database Preview

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

Levonorgestrel has one hundred and one 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
Zagazig UniversityPhase 2/Phase 3
Cairo UniversityPhase 3
Laboratorios Andromaco S.A.Phase 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
Fdn Consumer PLAN B ONE-STEP levonorgestrel TABLET;ORAL 021998-001 Jul 10, 2009 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 207044-001 Mar 25, 2016 OTC No No   Start Trial   Start Trial   Start Trial
Wyeth Pharms Inc LEVONORGESTREL levonorgestrel IMPLANT;IMPLANTATION 020627-001 Aug 15, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Naari Pte Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 207660-001 May 2, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Wyeth Pharms Inc NORPLANT SYSTEM IN PLASTIC CONTAINER levonorgestrel IMPLANT;IMPLANTATION 020088-001 Dec 10, 1990 DISCN No No   Start Trial   Start Trial   Start 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
Bayer Hlthcare SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159-001 Jan 9, 2013   Start Trial   Start Trial
Population Council NORPLANT levonorgestrel IMPLANT;IMPLANTATION 019897-001 Dec 10, 1990   Start Trial   Start Trial
Wyeth Pharms Inc NORPLANT SYSTEM IN PLASTIC CONTAINER levonorgestrel IMPLANT;IMPLANTATION 020088-001 Dec 10, 1990   Start Trial   Start Trial
Population Council NORPLANT levonorgestrel IMPLANT;IMPLANTATION 019897-001 Dec 10, 1990   Start Trial   Start Trial
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LEVONORGESTREL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 132016000025143 Italy   Start Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521 39/2015 Austria   Start 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 C201630040 Spain   Start 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 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Mallinckrodt
Boehringer Ingelheim
McKesson
Dow

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.