NORPLANT Drug Patent Profile
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Which patents cover Norplant, and when can generic versions of Norplant launch?
Norplant is a drug marketed by Population Council and Wyeth Pharms Inc and is included in two NDAs.
The generic ingredient in NORPLANT is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Norplant
A generic version of NORPLANT was approved as levonorgestrel by NOVEL LABS INC on February 22nd, 2013.
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Summary for NORPLANT
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 7 |
| Patent Applications: | 4,728 |
| DailyMed Link: | NORPLANT at DailyMed |
Recent Clinical Trials for NORPLANT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Women and Infants Hospital of Rhode Island | N/A |
| Oregon Health and Science University | Phase 4 |
| Society of Family Planning | Phase 4 |
US Patents and Regulatory Information for NORPLANT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Population Council | NORPLANT | levonorgestrel | IMPLANT;IMPLANTATION | 019897-001 | Dec 10, 1990 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wyeth Pharms Inc | NORPLANT SYSTEM IN PLASTIC CONTAINER | levonorgestrel | IMPLANT;IMPLANTATION | 020088-001 | Dec 10, 1990 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 NORPLANT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Population Council | NORPLANT | levonorgestrel | IMPLANT;IMPLANTATION | 019897-001 | Dec 10, 1990 | ⤷ Sign Up | ⤷ Sign Up |
| Population Council | NORPLANT | levonorgestrel | IMPLANT;IMPLANTATION | 019897-001 | Dec 10, 1990 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NORPLANT
See the table below for patents covering NORPLANT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| France | 1393968 | Substances stéroïdes dérivant de la 19-nortestostérone et leurs procédés de préparation | ⤷ Sign Up |
| Sweden | 322213 | ⤷ Sign Up | |
| Philippines | 11432 | SYNTHESIS OF 13-POLYCARBONALKYLGONA-2,5(10)-DIENE-17-OLS | ⤷ Sign Up |
| Germany | 1443123 | ⤷ Sign Up | |
| Sweden | 354064 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NORPLANT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 300814 | Netherlands | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 1453521 | 15C0050 | France | ⤷ Sign Up | 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 | C 2015 029 | Romania | ⤷ Sign Up | 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 | C201630040 | Spain | ⤷ Sign Up | 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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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.
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