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Last Updated: June 14, 2021

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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 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
National Cancer Institute (NCI)Phase 3
Botswana Harvard AIDS Institute PartnershipPhase 4
Wake Forest University Health SciencesPhase 3

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
Perrigo R And D LEVONORGESTREL levonorgestrel TABLET;ORAL 202334-001 Aug 20, 2014 OTC No No   Get Started Free   Get Started Free   Get Started Free
Lotus Pharm Co Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 202684-001 Sep 2, 2016 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Laboratoire Hra LEVONORGESTREL levonorgestrel TABLET;ORAL 204044-001 Jul 3, 2018 OTC No No   Get Started Free   Get Started Free   Get Started Free
L Perrigo Co LEVONORGESTREL levonorgestrel TABLET;ORAL 090740-001 Dec 30, 2010 OTC No Yes   Get Started Free   Get Started Free   Get Started Free
Fdn Consumer PLAN B levonorgestrel TABLET;ORAL 021045-001 Jul 28, 1999 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Watson Labs LEVONORGESTREL levonorgestrel TABLET;ORAL 078666-001 Jun 24, 2009 DISCN No No   Get Started Free   Get Started Free   Get Started Free
L Perrigo Co LEVONORGESTREL levonorgestrel TABLET;ORAL 090740-001 Dec 30, 2010 RX No Yes   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Wyeth Pharms Inc NORPLANT SYSTEM IN PLASTIC CONTAINER levonorgestrel IMPLANT;IMPLANTATION 020088-001 Dec 10, 1990   Get Started Free   Get Started Free
Bayer Hlthcare SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159-001 Jan 9, 2013   Get Started Free   Get Started Free
Population Council NORPLANT levonorgestrel IMPLANT;IMPLANTATION 019897-001 Dec 10, 1990   Get Started Free   Get Started Free
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LEVONORGESTREL

Country Patent Number Estimated Expiration
Austria 387898   Get Started Free
Japan 5390618   Get Started Free
South Korea 20110074741   Get Started Free
World Intellectual Property Organization (WIPO) 2013009674   Get Started Free
European Patent Office 2352470   Get Started Free
Mexico 2011002671   Get Started Free
Ukraine 112315   Get Started Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for LEVONORGESTREL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 93156 Luxembourg   Get Started Free PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 39/2015 Austria   Get Started Free 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 122015000093 Germany   Get Started Free PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 15C0050 France   Get Started Free 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 132016000025143 Italy   Get Started Free PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521 300814 Netherlands   Get Started Free PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 CA 2016 00016 Denmark   Get Started Free PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 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.