NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 5 pharmaceutical companies such as ORGANON, AMNEAL, TEVA PHARMS USA INC and others. It is marketed under 6 brand names, including NEXPLANON, ELURYNG, ETHINYL ESTRADIOL; ETONOGESTREL and others. Available in 2 different strengths, such as 68MG/IMPLANT, 0.015MG/24HR;0.12MG/24HR, and administered through 2 routes including IMPLANT;IMPLANTATION, RING;VAGINAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"60570","ingredient":"ETONOGESTREL","trade_name":"NEXPLANON","family_id":"a832828eca0c4c6c822d","publication_number":"US8888745B2","cleaned_patent_number":"8888745","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-08-28","publication_date":"2014-11-18","legal_status":"Granted"} | US8888745B2 Formulation | 18 Nov, 2014 | Granted | 28 Aug, 2026 | |
| {"application_id":"60519","ingredient":"ETONOGESTREL","trade_name":"NEXPLANON","family_id":"71fcba9b2cd44310964c","publication_number":"US10821277B2","cleaned_patent_number":"10821277","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-31","publication_date":"2020-11-03","legal_status":"Granted"} | US10821277B2 Formulation | 03 Nov, 2020 | Granted | 31 May, 2027 | |
| {"application_id":"60536","ingredient":"ETONOGESTREL","trade_name":"NEXPLANON","family_id":"64efd9b2befd40319037","publication_number":"US8722037B2","cleaned_patent_number":"8722037","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-09-28","publication_date":"2014-05-13","legal_status":"Granted"} | US8722037B2 Formulation | 13 May, 2014 | Granted | 28 Sep, 2027 | |
| {"application_id":"60488","ingredient":"ETONOGESTREL","trade_name":"IMPLANON","family_id":"4b1570bf3c76450d994a","publication_number":"US9757552B2","cleaned_patent_number":"9757552","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-28","publication_date":"2017-09-12","legal_status":"Granted"} | US9757552B2 Formulation | 12 Sep, 2017 | Granted | 28 Jul, 2030 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.