NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as COMMAVE THERAP. It is marketed under 1 brand name, including AZSTARYS. Available in 3 different strengths, such as EQ 5.2MG BASE;EQ 26.1MG BASE, EQ 7.8MG BASE;EQ 39.2MG BASE, EQ 10.4MG BASE;EQ 52.3MG BASE, and administered through 1 route including CAPSULE;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":"45892","ingredient":"DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE","trade_name":"AZSTARYS","family_id":"6d1cd10785284e81b2c6","publication_number":"US9079928B2","cleaned_patent_number":"9079928","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-27","publication_date":"2015-07-14","legal_status":"Granted"} | US9079928B2 Formulation | 14 Jul, 2015 | Granted | 27 Jul, 2032 | |
| {"application_id":"45877","ingredient":"DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE","trade_name":"AZSTARYS","family_id":"1e62b8971b6d4008a751","publication_number":"US10584112B2","cleaned_patent_number":"10584112","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-09","publication_date":"2020-03-10","legal_status":"Granted"} | US10584112B2 Molecular Formulation | 10 Mar, 2020 | Granted | 09 Dec, 2037 | |
| {"application_id":"45878","ingredient":"DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE","trade_name":"AZSTARYS","family_id":"1e62b8971b6d4008a751","publication_number":"US10584113B2","cleaned_patent_number":"10584113","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-09","publication_date":"2020-03-10","legal_status":"Granted"} | US10584113B2 Formulation | 10 Mar, 2020 | Granted | 09 Dec, 2037 | |
| {"application_id":"45879","ingredient":"DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE","trade_name":"AZSTARYS","family_id":"1e62b8971b6d4008a751","publication_number":"US10759778B2","cleaned_patent_number":"10759778","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-09","publication_date":"2020-09-01","legal_status":"Granted"} | US10759778B2 Formulation | 01 Sep, 2020 | Granted | 09 Dec, 2037 | |
| {"application_id":"45865","ingredient":"DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE","trade_name":"AZSTARYS","family_id":"1e62b8971b6d4008a751","publication_number":"US10858341B2","cleaned_patent_number":"10858341","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-09","publication_date":"2020-12-08","legal_status":"Granted"} | US10858341B2 | 08 Dec, 2020 | Granted | 09 Dec, 2037 | |
| {"application_id":"45881","ingredient":"DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE","trade_name":"AZSTARYS","family_id":"1e62b8971b6d4008a751","publication_number":"US10954213B2","cleaned_patent_number":"10954213","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-09","publication_date":"2021-03-23","legal_status":"Granted"} | US10954213B2 | 23 Mar, 2021 | Granted | 09 Dec, 2037 |
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.