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Serving leading biopharmaceutical companies globally:

Fuji
Harvard Business School
Cantor Fitzgerald
Baxter
Julphar
Chinese Patent Office
Healthtrust
AstraZeneca
Colorcon
Accenture

Generated: October 23, 2017

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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 levonorgestrel freedom to operate?

Levonorgestrel
is the generic ingredient in fourteen branded drugs marketed by Novel Labs Inc, Bayer Hlthcare, Wyeth Pharms Inc, Lupin Ltd, Medicines360, Perrigo R And D, Sun Pharm Inds Ltd, Mylan Labs Ltd, Population Council, Glenmark Pharms Ltd, Teva Branded Pharm, Reckitt Benckiser, Watson Labs, Aurobindo Pharma Ltd, Watson Labs Inc, Novast Labs Ltd, Oc Pharma, and Lotus Pharm Co Ltd, 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 and five supplementary protection certificates in five countries.

There are twenty drug master file entries for levonorgestrel. Twenty-seven suppliers are listed for this compound.

Summary for Generic Name: levonorgestrel

US Patents:3
Tradenames:14
Applicants:18
NDAs:27
Drug Master File Entries: see list20
Suppliers / Packagers: see list27
Bulk Api Vendors: see list44
Clinical Trials: see list172
Patent Applications: see list5,066
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:levonorgestrel at DailyMed

Pharmacology for Ingredient: levonorgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Population Council
NORPLANT
levonorgestrel
IMPLANT;IMPLANTATION019897-001Dec 10, 1990DISCNNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
FALLBACK SOLO
levonorgestrel
TABLET;ORAL201446-001Jun 19, 2014OTCNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
SKYLA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE203159-001Jan 9, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 2000RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
KYLEENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Teva Branded Pharm
PLAN B ONE-STEP
levonorgestrel
TABLET;ORAL021998-001Jul 10, 2009OTCYesYes► Subscribe► Subscribe► Subscribe
Lotus Pharm Co Ltd
LEVONORGESTREL
levonorgestrel
TABLET;ORAL202684-001Sep 2, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Branded Pharm
PLAN B
levonorgestrel
TABLET;ORAL021045-002Aug 24, 2006DISCNYesNo► Subscribe► Subscribe► Subscribe
Novast Labs Ltd
HER STYLE
levonorgestrel
TABLET;ORAL207976-001Mar 11, 2016OTCNoNo► Subscribe► Subscribe► Subscribe
Perrigo R And D
LEVONORGESTREL
levonorgestrel
TABLET;ORAL202334-001Aug 20, 2014OTCNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: levonorgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 2000► Subscribe► Subscribe
Population Council
NORPLANT
levonorgestrel
IMPLANT;IMPLANTATION019897-001Dec 10, 1990► Subscribe► Subscribe
Bayer Hlthcare
SKYLA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE203159-001Jan 9, 2013► Subscribe► Subscribe
Wyeth Pharms Inc
NORPLANT SYSTEM IN PLASTIC CONTAINER
levonorgestrel
IMPLANT;IMPLANTATION020088-001Dec 10, 1990► Subscribe► Subscribe
Population Council
NORPLANT
levonorgestrel
IMPLANT;IMPLANTATION019897-001Dec 10, 1990► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,452,082Inserter► Subscribe
D791318Inserter► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: levonorgestrel

Country Document Number Estimated Expiration
Poland214245► Subscribe
China102159160► Subscribe
Mexico2011002670► Subscribe
World Intellectual Property Organization (WIPO)2010031902► Subscribe
CroatiaP20121071► Subscribe
Poland2349143► Subscribe
Poland374112► Subscribe
Russian Federation2011115057► Subscribe
Norway20051858► Subscribe
Slovenia1539063► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LEVONORGESTREL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Teva
Mallinckrodt
Healthtrust
Express Scripts
Deloitte
Harvard Business School
Cipla
Farmers Insurance
Fish and Richardson

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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