NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 5 pharmaceutical companies such as DUCHESNAY, ACTAVIS LABS FL INC, ENDO OPERATIONS and others. It is marketed under 3 brand names, including DICLEGIS, DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, BONJESTA. Available in 2 different strengths, such as 10MG;10MG, 20MG;20MG, and administered through 2 routes including TABLET, DELAYED RELEASE;ORAL, 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":"84667","ingredient":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","trade_name":"BONJESTA","family_id":"b52428f4e8a74e5697ae","publication_number":"US9089489B2","cleaned_patent_number":"9089489","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-18","publication_date":"2015-07-28","legal_status":"Granted"} | US9089489B2 Formulation | 28 Jul, 2015 | Granted | 18 Feb, 2033 | |
| {"application_id":"84668","ingredient":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","trade_name":"BONJESTA","family_id":"b52428f4e8a74e5697ae","publication_number":"US9375404B2","cleaned_patent_number":"9375404","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-18","publication_date":"2016-06-28","legal_status":"Granted"} | US9375404B2 Formulation | 28 Jun, 2016 | Granted | 18 Feb, 2033 | |
| {"application_id":"84673","ingredient":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","trade_name":"BONJESTA","family_id":"8c30b44e1f2c426d8ca0","publication_number":"US9526703B2","cleaned_patent_number":"9526703","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-18","publication_date":"2016-12-27","legal_status":"Granted"} | US9526703B2 Formulation | 27 Dec, 2016 | Granted | 18 Feb, 2033 | |
| {"application_id":"84644","ingredient":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","trade_name":"BONJESTA","family_id":"b52428f4e8a74e5697ae","publication_number":"US9937132B2","cleaned_patent_number":"9937132","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-18","publication_date":"2018-04-10","legal_status":"Granted"} | US9937132B2 Formulation | 10 Apr, 2018 | Granted | 18 Feb, 2033 |
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.