NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 5 pharmaceutical companies such as AZURITY, THEPHARMANETWORK LLC, SOFGEN PHARMS and others. It is marketed under 2 brand names, including NYMALIZE, NIMODIPINE. Available in 3 different strengths, such as 3MG/ML, 30MG, 6MG/ML, and administered through 2 routes including SOLUTION;ORAL, 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":"76678","ingredient":"NIMODIPINE","trade_name":"NYMALIZE","family_id":"9c1570d0440249e6844e","publication_number":"US10342787B1","cleaned_patent_number":"10342787","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-16","publication_date":"2019-07-09","legal_status":"Patented case"} | US10342787B2 Formulation | 09 Jul, 2019 | Patented case | 16 Apr, 2038 | |
| {"application_id":"76680","ingredient":"NIMODIPINE","trade_name":"NYMALIZE","family_id":"9c1570d0440249e6844e","publication_number":"US10576070B2","cleaned_patent_number":"10576070","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-16","publication_date":"2020-03-03","legal_status":"Granted"} | US10576070B2 Formulation | 03 Mar, 2020 | Granted | 16 Apr, 2038 | |
| {"application_id":"76681","ingredient":"NIMODIPINE","trade_name":"NYMALIZE","family_id":"9c1570d0440249e6844e","publication_number":"US11207306B2","cleaned_patent_number":"11207306","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-16","publication_date":"2021-12-28","legal_status":"Granted"} | US11207306B2 | 28 Dec, 2021 | Granted | 16 Apr, 2038 | |
| {"application_id":"76684","ingredient":"NIMODIPINE","trade_name":"NYMALIZE","family_id":"9c1570d0440249e6844e","publication_number":"US11413277B2","cleaned_patent_number":"11413277","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-16","publication_date":"2022-08-16","legal_status":"Patented case"} | US11413277B2 Formulation | 16 Aug, 2022 | Patented case | 16 Apr, 2038 | |
| {"application_id":"76682","ingredient":"NIMODIPINE","trade_name":"NYMALIZE","family_id":"9c1570d0440249e6844e","publication_number":"US11806338B2","cleaned_patent_number":"11806338","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-16","publication_date":"2023-11-07","legal_status":"Granted"} | US11806338B2 Formulation | 07 Nov, 2023 | Granted | 16 Apr, 2038 | |
| {"application_id":"139392","ingredient":"NIMODIPINE","trade_name":"NYMALIZE","family_id":"9c1570d0440249e6844e","publication_number":"US12186308B2","cleaned_patent_number":"12186308","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-16","publication_date":"2025-01-07","legal_status":"Granted"} | US12186308B2 Formulation | 07 Jan, 2025 | Granted | 16 Apr, 2038 |
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.