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Levonorgestrel - Generic Drug Details

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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, Lotus Pharm Co Ltd, Watson Labs, Aurobindo Pharma Ltd, Watson Labs Inc, Novast Labs Ltd, and Oc Pharma, and is included in twenty-seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty patent family members in twenty-six countries.

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

Summary for Generic Name: levonorgestrel

Tradenames:14
Patents:1
Applicants:17
NDAs:27
Drug Master File Entries: see list20
Suppliers / Packagers: see list29
Bulk Api Vendors: see list44
Clinical Trials: see list64
Patent Applications: see list3,691
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 2000RXYesYes► subscribe► subscribe
Novast Labs Ltd
HER STYLE
levonorgestrel
TABLET;ORAL207976-001Mar 11, 2016OTCNoNo► subscribe► subscribe
Lupin Ltd
FALLBACK SOLO
levonorgestrel
TABLET;ORAL201446-001Jun 19, 2014OTCNoNo► 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
Population Council
NORPLANT
levonorgestrel
IMPLANT;IMPLANTATION019897-001Dec 10, 19903,850,911► subscribe
Bayer Hlthcare
MIRENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE021225-001Dec 6, 20005,785,053► subscribe
Bayer Hlthcare
SKYLA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE203159-001Jan 9, 20135,785,053► subscribe
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International Patent Family for Ingredient: levonorgestrel

Country Document Number Estimated Expiration
Russian Federation2297810► subscribe
World Intellectual Property Organization (WIPO)2004026196► subscribe
Brazil0314287► 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
2016 00016Denmark► subscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
156Luxembourg► subscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0814Netherlands► subscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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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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