NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 11 pharmaceutical companies such as SPECGX LLC, RISING, HOSPIRA INC and others. It is marketed under 3 brand names, including EXALGO, HYDROMORPHONE HYDROCHLORIDE, DILAUDID. Available in 16 different strengths, such as 16MG, 8MG, 12MG and others, and administered through 5 routes including TABLET, EXTENDED RELEASE;ORAL, INJECTABLE;INJECTION, TABLET;ORAL and others.
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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":"61625","ingredient":"HYDROMORPHONE HYDROCHLORIDE","trade_name":"DILAUDID","family_id":"c11deb4578ad48c58d3b","publication_number":"US9731082B2","cleaned_patent_number":"9731082","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-04-23","publication_date":"2017-08-15","legal_status":"Granted"} | US9731082B2 Formulation | 15 Aug, 2017 | Granted | 23 Apr, 2032 | |
| {"application_id":"61636","ingredient":"HYDROMORPHONE HYDROCHLORIDE","trade_name":"DILAUDID","family_id":"06537d31a03d40f29abf","publication_number":"US9248229B2","cleaned_patent_number":"9248229","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-12","publication_date":"2016-02-02","legal_status":"Granted"} | US9248229B2 Formulation | 02 Feb, 2016 | Granted | 12 Mar, 2034 |
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.