levonorgestrel - Profile
✉ Email this page to a colleague
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, Novast Labs, Alvogen, Annora Pharma, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Lupin Ltd, Naari Pte, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, and Sun Pharm, and is included in thirty-one NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Levonorgestrel has one hundred and thirteen patent family members in thirty-five countries.
Summary for levonorgestrel
| International Patents: | 113 |
| US Patents: | 7 |
| Tradenames: | 14 |
| Applicants: | 21 |
| NDAs: | 31 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Population Council | JADELLE | levonorgestrel | IMPLANT;IMPLANTATION | 020544-001 | Nov 1, 1996 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Wyeth Pharms Inc | LEVONORGESTREL | levonorgestrel | IMPLANT;IMPLANTATION | 020627-001 | Aug 15, 1996 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Population Council | NORPLANT | levonorgestrel | IMPLANT;IMPLANTATION | 019897-001 | Dec 10, 1990 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Wyeth Pharms Inc | NORPLANT SYSTEM IN PLASTIC CONTAINER | levonorgestrel | IMPLANT;IMPLANTATION | 020088-001 | Dec 10, 1990 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bayer Hlthcare | KYLEENA | levonorgestrel | SYSTEM;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | 11,850,182 | ⤷ Start Trial | Y | ⤷ Start 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 |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | KYLEENA | levonorgestrel | SYSTEM;INTRAUTERINE | 208224-001 | Sep 16, 2016 | 7,252,839 | ⤷ Start Trial |
| Population Council | NORPLANT | levonorgestrel | IMPLANT;IMPLANTATION | 019897-001 | Dec 10, 1990 | 3,850,911 | ⤷ Start Trial |
| Bayer Hlthcare | MIRENA | levonorgestrel | SYSTEM;INTRAUTERINE | 021225-001 | Dec 6, 2000 | 5,785,053 | ⤷ Start Trial |
| Wyeth Pharms Inc | NORPLANT SYSTEM IN PLASTIC CONTAINER | levonorgestrel | IMPLANT;IMPLANTATION | 020088-001 | Dec 10, 1990 | 3,850,911 | ⤷ Start Trial |
| Bayer Hlthcare | SKYLA | levonorgestrel | SYSTEM;INTRAUTERINE | 203159-001 | Jan 9, 2013 | 7,252,839 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for levonorgestrel
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2012282832 | ⤷ Start Trial | |
| Australia | 2015221468 | ⤷ Start Trial | |
| Brazil | 112014000440 | ⤷ Start Trial | |
| Brazil | 122015016218 | ⤷ Start Trial | |
| Canada | 2841855 | ⤷ Start Trial | |
| >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 | ⤷ Start 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 | 122015000093 | Germany | ⤷ Start 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 | ⤷ Start Trial | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
| 1453521 | 39/2015 | Austria | ⤷ Start 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 |
| 1453521 | 93156 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
