NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 3 pharmaceutical companies such as SOVEREIGN PHARMS, CHARTWELL RX, ECI PHARMS LLC. It is marketed under 4 brand names, including OBREDON, FLOWTUSS, HYCOFENIX and others. Available in 3 different strengths, such as 200MG/5ML;2.5MG/5ML, 200MG/5ML;2.5MG/5ML;30MG/5ML, 400MG;5MG, and administered through 2 routes including SOLUTION;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":"76695","ingredient":"GUAIFENESIN; HYDROCODONE BITARTRATE","trade_name":"OBREDON","family_id":"db34e79f932e47998ab4","publication_number":"US10105324B2","cleaned_patent_number":"10105324","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-13","publication_date":"2018-10-23","legal_status":"Granted"} | US10105324B2 Molecular Formulation | 23 Oct, 2018 | Granted | 13 Nov, 2035 | |
| {"application_id":"76693","ingredient":"GUAIFENESIN; HYDROCODONE BITARTRATE","trade_name":"OBREDON","family_id":"db34e79f932e47998ab4","publication_number":"US9549907B1","cleaned_patent_number":"9549907","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-13","publication_date":"2017-01-24","legal_status":"Granted"} | US9549907B2 Molecular Formulation | 24 Jan, 2017 | Granted | 13 Nov, 2035 | |
| {"application_id":"76694","ingredient":"GUAIFENESIN; HYDROCODONE BITARTRATE","trade_name":"OBREDON","family_id":"db34e79f932e47998ab4","publication_number":"US9808431B2","cleaned_patent_number":"9808431","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-13","publication_date":"2017-11-07","legal_status":"Granted"} | US9808431B2 Molecular Formulation | 07 Nov, 2017 | Granted | 13 Nov, 2035 |
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.