LEVONORGESTREL - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug 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 eight 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: | 8 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | MIRENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 021225-001 | Dec 6, 2000 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Lupin Ltd | LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 091328-001 | Jan 23, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Fdn Consumer | LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 078665-001 | Aug 28, 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 | ⤷ Try a Trial | ||||
Watson Labs | LEVONORGESTREL | levonorgestrel | TABLET;ORAL | 078666-001 | Jun 24, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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
International Patents for LEVONORGESTREL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 104023681 | Intraurinary systems, IUD insertion devices, and related methods and kits therefor | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2013009674 | ⤷ Try a Trial | |
Mexico | 2007011820 | UN SISTEMA INTRAUTERINO DETECTABLE ULTRASONICAMENTE Y UN METODO PARA MEJORAR LA DETECCION DEL ULTRASONIDO. (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM AND A METHOD FOR ENHANCING ULTRASOUND DETECTION.) | ⤷ Try a Trial |
Japan | 7392929 | ⤷ Try a Trial | |
Hong Kong | 1155350 | AN INSERTER | ⤷ Try a Trial |
Lithuania | 1871314 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2010031900 | ⤷ 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 | C 2015 029 | Romania | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
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 | 132016000025143 | Italy | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
1453521 | 15C0050 | France | ⤷ Try a Trial | 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 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
1453521 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
1453521 | 39/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.