NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 23 pharmaceutical companies such as LUPIN LTD, TEVA PHARMS USA, TORRENT and others. It is marketed under 2 brand names, including DULOXETINE HYDROCHLORIDE, DRIZALMA SPRINKLE. Available in 4 different strengths, such as EQ 40MG BASE, EQ 30MG BASE, EQ 20MG BASE and others, and administered through 1 route including CAPSULE, DELAYED REL PELLETS;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":"43586","ingredient":"DULOXETINE HYDROCHLORIDE","trade_name":"DRIZALMA SPRINKLE","family_id":"fd31aa5f44354b4b8409","publication_number":"US10413525B2","cleaned_patent_number":"10413525","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-13","publication_date":"2019-09-17","legal_status":"Granted"} | US10413525B2 Formulation | 17 Sep, 2019 | Granted | 13 Apr, 2037 | |
| {"application_id":"43583","ingredient":"DULOXETINE HYDROCHLORIDE","trade_name":"DRIZALMA SPRINKLE","family_id":"fd31aa5f44354b4b8409","publication_number":"US10959982B2","cleaned_patent_number":"10959982","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-13","publication_date":"2021-03-30","legal_status":"Granted"} | US10959982B2 Formulation | 30 Mar, 2021 | Granted | 13 Apr, 2037 | |
| {"application_id":"43587","ingredient":"DULOXETINE HYDROCHLORIDE","trade_name":"DRIZALMA SPRINKLE","family_id":"fd31aa5f44354b4b8409","publication_number":"US11202772B2","cleaned_patent_number":"11202772","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-13","publication_date":"2021-12-21","legal_status":"Granted"} | US11202772B2 Formulation | 21 Dec, 2021 | Granted | 13 Apr, 2037 | |
| {"application_id":"43589","ingredient":"DULOXETINE HYDROCHLORIDE","trade_name":"DRIZALMA SPRINKLE","family_id":"fd31aa5f44354b4b8409","publication_number":"US20220054452A1","cleaned_patent_number":"12171742","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-13","publication_date":"2022-02-24","legal_status":"Pending"} | US12171742B2 Formulation | 24 Feb, 2022 | Pending | 13 Apr, 2037 | |
| {"application_id":"43585","ingredient":"DULOXETINE HYDROCHLORIDE","trade_name":"DRIZALMA SPRINKLE","family_id":"fd31aa5f44354b4b8409","publication_number":"US9839626B1","cleaned_patent_number":"9839626","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-04-13","publication_date":"2017-12-12","legal_status":"Granted"} | US9839626B2 Formulation | 12 Dec, 2017 | Granted | 13 Apr, 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.