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Last Updated: December 8, 2022

Levonorgestrel - Generic Drug Details


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What are the generic drug sources for levonorgestrel and what is the scope of freedom to operate?

Levonorgestrel is the generic ingredient in fourteen branded drugs marketed by Population Council, Wyeth Pharms Inc, Bayer Hlthcare, Medicines360, Aurobindo Pharma, 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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levonorgestrel has one hundred and three 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
Biós FarmacêuticaPhase 2
Hua LiPhase 2/Phase 3
Science Valley Research InstitutePhase 2

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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 LEVONORGESTREL levonorgestrel TABLET;ORAL 078665-001 Aug 28, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Naari Pte Ltd LEVONORGESTREL levonorgestrel TABLET;ORAL 202380-001 May 29, 2015 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare KYLEENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare MIRENA levonorgestrel INTRAUTERINE DEVICE;INTRAUTERINE 021225-001 Dec 6, 2000 See Plans and Pricing See Plans and Pricing
Wyeth Pharms Inc NORPLANT SYSTEM IN PLASTIC CONTAINER levonorgestrel IMPLANT;IMPLANTATION 020088-001 Dec 10, 1990 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for levonorgestrel

Country Patent Number Title Estimated Expiration
Norway 331466 See Plans and Pricing
Poland 374112 Układ doprowadzający i sposób wytwarzania układu doprowadzającego (A DELIVERY SYSTEM AND A MANUFACTURING PROCESS OF A DELIVERY SYSTEM) See Plans and Pricing
Mexico 2014000405 SISTEMAS INTRAUTERINOS, DISPOSITIVOS DE INSERCION DIU, Y METODOS RELACIONADOS Y KITS DE LOS MISMOS. (INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for levonorgestrel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 15C0050 France See Plans and Pricing 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 CA 2016 00016 Denmark See Plans and Pricing PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 93156 Luxembourg See Plans and Pricing PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.