NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 5 pharmaceutical companies such as FRESENIUS KABI USA, AVET LIFESCIENCES, NOVEL LABS INC and others. It is marketed under 3 brand names, including METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE, GIMOTI. Available in 4 different strengths, such as EQ 5MG BASE/ML, EQ 5MG BASE, EQ 10MG BASE and others, and administered through 4 routes including INJECTABLE;INJECTION, TABLET, ORALLY DISINTEGRATING;ORAL, SPRAY, METERED;NASAL and others.
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Licensing: 5 potential partnersUS Launch window: Loading launch window...
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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":"81036","ingredient":"METOCLOPRAMIDE HYDROCHLORIDE","trade_name":"GIMOTI","family_id":"e3775868ac104306beb8","publication_number":"US11020361B2","cleaned_patent_number":"11020361","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-22","publication_date":"2021-06-01","legal_status":"Granted"} | US11020361B2 | 01 Jun, 2021 | Granted | 22 Dec, 2029 | |
| {"application_id":"81048","ingredient":"METOCLOPRAMIDE HYDROCHLORIDE","trade_name":"GIMOTI","family_id":"e3775868ac104306beb8","publication_number":"US11628150B2","cleaned_patent_number":"11628150","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-22","publication_date":"2023-04-18","legal_status":"Granted"} | US11628150B2 Formulation | 18 Apr, 2023 | Granted | 22 Dec, 2029 | |
| {"application_id":"81051","ingredient":"METOCLOPRAMIDE HYDROCHLORIDE","trade_name":"GIMOTI","family_id":"e3775868ac104306beb8","publication_number":"US11813231B2","cleaned_patent_number":"11813231","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-22","publication_date":"2023-11-14","legal_status":"Granted"} | US11813231B2 Formulation | 14 Nov, 2023 | Granted | 22 Dec, 2029 | |
| {"application_id":"81049","ingredient":"METOCLOPRAMIDE HYDROCHLORIDE","trade_name":"GIMOTI","family_id":"e3775868ac104306beb8","publication_number":"US20210330618A1","cleaned_patent_number":"12194008","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-22","publication_date":"2025-01-14","legal_status":"Pending"} | US12194008B2 | 14 Jan, 2025 | Pending | 22 Dec, 2029 | |
| {"application_id":"81050","ingredient":"METOCLOPRAMIDE HYDROCHLORIDE","trade_name":"GIMOTI","family_id":"e3775868ac104306beb8","publication_number":"US20210330619A1","cleaned_patent_number":"12194009","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-22","publication_date":"2025-01-14","legal_status":"Pending"} | US12194009B2 | 14 Jan, 2025 | Pending | 22 Dec, 2029 | |
| {"application_id":"81045","ingredient":"METOCLOPRAMIDE HYDROCHLORIDE","trade_name":"GIMOTI","family_id":"e3775868ac104306beb8","publication_number":"US8334281B2","cleaned_patent_number":"8334281","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-16","publication_date":"2012-12-18","legal_status":"Patented case"} | US8334281B2 Formulation | 18 Dec, 2012 | Patented case | 16 May, 2030 |
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.