NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as PURDUE PHARMA LP. It is marketed under 1 brand name, including TARGINIQ. Available in 3 different strengths, such as 5MG;10MG, 10MG;20MG, 20MG;40MG, and administered through 1 route including TABLET, EXTENDED RELEASE;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":"4147","ingredient":"NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","trade_name":"TARGINIQ","family_id":"e6444ccd37ea442bbd60","publication_number":"US9073933B2","cleaned_patent_number":"9073933","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-30","publication_date":"2015-07-07","legal_status":"Granted"} | US9073933B2 Molecular | 07 Jul, 2015 | Granted | 30 Mar, 2025 | |
| {"application_id":"4017","ingredient":"NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","trade_name":"TARGINIQ","family_id":"e6444ccd37ea442bbd60","publication_number":"US9522919B2","cleaned_patent_number":"9522919","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-30","publication_date":"2016-12-20","legal_status":"Expired"} | US9522919B2 Molecular Formulation | 20 Dec, 2016 | Expired | 30 Mar, 2025 |
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.