Etonogestrel - Generic Drug Details
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What are the generic drug sources for etonogestrel and what is the scope of freedom to operate?
Etonogestrel
is the generic ingredient in two branded drugs marketed by Organon and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Etonogestrel has one hundred and five patent family members in thirty-five countries.
There are five drug master file entries for etonogestrel. One supplier is listed for this compound.
Summary for etonogestrel
International Patents: | 105 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 75 |
Patent Applications: | 3,462 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for etonogestrel |
What excipients (inactive ingredients) are in etonogestrel? | etonogestrel excipients list |
DailyMed Link: | etonogestrel at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for etonogestrel
Generic Entry Date for etonogestrel*:
Constraining patent/regulatory exclusivity:
Dosage:
IMPLANT;IMPLANTATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for etonogestrel
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bill and Melinda Gates Foundation | Phase 4 |
Lori Gawron | Phase 4 |
Planned Parenthood Association of Utah | Phase 4 |
Pharmacology for etonogestrel
Drug Class | Progestin |
Anatomical Therapeutic Chemical (ATC) Classes for etonogestrel
US Patents and Regulatory Information for etonogestrel
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon | IMPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529-001 | Jul 17, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Organon | NEXPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529-002 | May 13, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Organon | NEXPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529-002 | May 13, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Organon | NEXPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529-002 | May 13, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Organon | NEXPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529-002 | May 13, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 etonogestrel
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | IMPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529-001 | Jul 17, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Organon | IMPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529-001 | Jul 17, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for etonogestrel
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1841493 | ⤷ Sign Up | |
New Zealand | 556490 | Applicator for inserting an implant | ⤷ Sign Up |
Japan | 4876077 | ⤷ Sign Up | |
Portugal | 3417905 | ⤷ Sign Up | |
European Patent Office | 1841492 | APPAREIL DE POSE D'IMPLANT (APPLICATOR FOR INSERTING AN IMPLANT) | ⤷ Sign Up |
Ecuador | SP066865 | DISPOSITIVO DE DISTRIBUCIÓN DE FÁRMACOS VISIBLE POR RAYOS X | ⤷ Sign Up |
Taiwan | 200534838 | X-ray visible drug delivery device | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for etonogestrel
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0303306 | SPC/GB99/044 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ETONOGESTREL; REGISTERED: NL RGV21168 19980825; UK 00065/0161 19990609 |
0303306 | 099C0041 | Belgium | ⤷ Sign Up | PRODUCT NAME: ETONOGESTREL; NATL. REGISTRATION NO/DATE: 52 IS 296 F 14 19990531; FIRST REGISTRATION: NL RVG 21168 19980825 |
0303306 | 29/1999 | Austria | ⤷ Sign Up | PRODUCT NAME: ETONOGESTREL; NAT. REGISTRATION NO/DATE: 1-22964 19990330; FIRST REGISTRATION: NL 21168 19980825 |
0303306 | C980027 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ETONOGESTREL; REGISTRATION NO/DATE: RVG 21168 19980825 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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