NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 12 pharmaceutical companies such as IMPAX LABS, HIKMA, ACTAVIS ELIZABETH and others. It is marketed under 2 brand names, including OXYMORPHONE HYDROCHLORIDE, OPANA ER. Available in 7 different strengths, such as 5MG, 20MG, 40MG and others, and administered through 2 routes including TABLET, EXTENDED RELEASE;ORAL, TABLET;ORAL.
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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":"85792","ingredient":"OXYMORPHONE HYDROCHLORIDE","trade_name":"OPANA ER","family_id":"eab5253525754da8b997","publication_number":"US8192722B2","cleaned_patent_number":"8192722","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-09-15","publication_date":"2012-06-05","legal_status":"Expired"} | US8192722B2 Formulation | 05 Jun, 2012 | Expired | 15 Sep, 2025 | |
| {"application_id":"86936","ingredient":"OXYMORPHONE HYDROCHLORIDE","trade_name":"OPANA ER","family_id":"8109906646b94c9780f5","publication_number":"US8808737B2","cleaned_patent_number":"8808737","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-21","publication_date":"2014-08-19","legal_status":"Granted"} | US8808737B2 | 19 Aug, 2014 | Granted | 21 Jun, 2027 | |
| {"application_id":"86961","ingredient":"OXYMORPHONE HYDROCHLORIDE","trade_name":"OPANA ER","family_id":"724cc03b0eca4fc6aa84","publication_number":"US7851482B2","cleaned_patent_number":"7851482","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-10","publication_date":"2010-12-14","legal_status":"Expired"} | US7851482B2 Molecular | 14 Dec, 2010 | Expired | 10 Jul, 2029 | |
| {"application_id":"86940","ingredient":"OXYMORPHONE HYDROCHLORIDE","trade_name":"OPANA ER","family_id":"08a8e0e701864f2dac8c","publication_number":"US8871779B2","cleaned_patent_number":"8871779","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-11-22","publication_date":"2014-10-28","legal_status":"Granted"} | US8871779B2 Molecular | 28 Oct, 2014 | Granted | 22 Nov, 2029 |
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.