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, 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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Levonorgestrel has one hundred and ten patent family members in thirty-five countries.
There are twenty drug master file entries for levonorgestrel. Thirty-four suppliers are listed for this compound.
Summary for LEVONORGESTREL
International Patents: | 110 |
US Patents: | 6 |
Tradenames: | 14 |
Applicants: | 20 |
NDAs: | 30 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 34 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 248 |
Patent Applications: | 5,759 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for LEVONORGESTREL |
What excipients (inactive ingredients) are in LEVONORGESTREL? | LEVONORGESTREL excipients list |
DailyMed Link: | LEVONORGESTREL at DailyMed |
Recent Clinical Trials for LEVONORGESTREL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Washington University School of Medicine | Phase 2 |
Novo Nordisk A/S | Phase 2 |
Arkansas Children's Hospital Research Institute | Phase 4 |
Pharmacology for LEVONORGESTREL
Drug Class | Progestin Progestin-containing Intrauterine Device Progestin-containing Intrauterine System |
Physiological Effect | Inhibit Ovum Fertilization |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Watson Labs | LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 078666-001 | Jun 24, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Medicines360 | LILETTA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 206229-001 | Feb 26, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Population Council | NORPLANT | levonorgestrel | IMPLANT;IMPLANTATION | 019897-001 | Dec 10, 1990 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 |
---|---|---|---|---|---|---|---|
Wyeth Pharms Inc | NORPLANT SYSTEM IN PLASTIC CONTAINER | levonorgestrel | IMPLANT;IMPLANTATION | 020088-001 | Dec 10, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
Population Council | NORPLANT | levonorgestrel | IMPLANT;IMPLANTATION | 019897-001 | Dec 10, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEVONORGESTREL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200709012 | An ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2010031900 | ⤷ Try a Trial | |
Ecuador | SP077804 | UN SISTEMA INTRAUTERINO DETECTABLE ULTRASÓNICAMENTE Y UN MÉTODO PARA MEJORAR LA DETECCIÓN DEL ULTRASONIDO | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEVONORGESTREL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | 93156 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
1453521 | C201630040 | Spain | ⤷ Try a Trial | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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