BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Boehringer Ingelheim
Fuji
Chubb
Queensland Health
Colorcon
Cerilliant
Citi
Fish and Richardson

Generated: January 17, 2018

DrugPatentWatch Database Preview

Levonorgestrel - Generic Drug Details

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What are the generic sources for levonorgestrel and what is the scope of levonorgestrel 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 Ltd, Glenmark Pharms Ltd, Lotus Pharm Co Ltd, Mylan Labs Ltd, Novel Labs Inc, Oc Pharma, Perrigo R And D, Reckitt Benckiser, Watson Labs, Watson Labs Inc, Sun Pharm Inds Ltd, and Teva Branded Pharm, and is included in twenty-seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levonorgestrel has seventy-seven patent family members in twenty-eight countries.

There are twenty drug master file entries for levonorgestrel. Twenty-seven suppliers are listed for this compound.
Summary for levonorgestrel
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
Aurobindo Pharma Ltd ATHENTIA NEXT levonorgestrel TABLET;ORAL 206867-001 Dec 8, 2015 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Labs Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 202740-001 Sep 2, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Branded Pharm PLAN B levonorgestrel TABLET;ORAL 021045-002 Aug 24, 2006 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Reckitt Benckiser LEVONORGESTREL levonorgestrel TABLET;ORAL 202246-001 Jun 5, 2015 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Population Council JADELLE levonorgestrel IMPLANT;IMPLANTATION 020544-001 Nov 1, 1996 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159-001 Jan 9, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bayer Hlthcare SKYLA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 203159-001 Jan 9, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Medicines360 LILETTA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 206229-001 Feb 26, 2015 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Branded Pharm PLAN B levonorgestrel TABLET;ORAL 021045-001 Jul 28, 1999 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Non-Orange Book US Patents for levonorgestrel

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
D791318 Inserter ➤ Subscribe
9,452,082 Inserter ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for levonorgestrel

Supplementary Protection Certificates for levonorgestrel

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000093 Germany ➤ Subscribe PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0814 Netherlands ➤ Subscribe PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2016 00016 Denmark ➤ Subscribe PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
/2015 Austria ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
156 Luxembourg ➤ Subscribe PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Cerilliant
Boehringer Ingelheim
McKinsey
Deloitte
UBS
Moodys
Harvard Business School
Farmers Insurance

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 verifification 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.

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