NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 10 pharmaceutical companies such as ZYDUS PHARMS, ALVOGEN, IMPAX LABS INC and others. It is marketed under 1 brand name, including PYRIDOSTIGMINE BROMIDE. Available in 5 different strengths, such as 60MG, 180MG, 60MG/5ML and others, and administered through 3 routes including TABLET;ORAL, TABLET, EXTENDED RELEASE;ORAL, SYRUP;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":"138518","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US10881617B1","cleaned_patent_number":"10881617","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2021-01-05","legal_status":"Granted"} | US10881617B2 Formulation | 05 Jan, 2021 | Granted | 18 Jun, 2038 | |
| {"application_id":"138516","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US10925833B2","cleaned_patent_number":"10925833","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2021-02-23","legal_status":"Granted"} | US10925833B2 Formulation | 23 Feb, 2021 | Granted | 18 Jun, 2038 | |
| {"application_id":"138517","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US10987311B2","cleaned_patent_number":"10987311","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2021-04-27","legal_status":"Patented Case"} | US10987311B2 Formulation | 27 Apr, 2021 | Patented Case | 18 Jun, 2038 | |
| {"application_id":"138521","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US11229606B2","cleaned_patent_number":"11229606","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2022-01-25","legal_status":"Granted"} | US11229606B2 Formulation | 25 Jan, 2022 | Granted | 18 Jun, 2038 | |
| {"application_id":"138514","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US11478425B2","cleaned_patent_number":"11478425","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2022-10-25","legal_status":"Granted"} | US11478425B2 Formulation | 25 Oct, 2022 | Granted | 18 Jun, 2038 | |
| {"application_id":"138519","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US11666536B2","cleaned_patent_number":"11666536","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2023-06-06","legal_status":"Granted"} | US11666536B2 Formulation | 06 Jun, 2023 | Granted | 18 Jun, 2038 | |
| {"application_id":"138520","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US11911515B2","cleaned_patent_number":"11911515","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2024-02-27","legal_status":"Granted"} | US11911515B2 Formulation | 27 Feb, 2024 | Granted | 18 Jun, 2038 | |
| {"application_id":"138515","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US12042559B2","cleaned_patent_number":"12042559","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2024-07-23","legal_status":"Granted"} | US12042559B2 Formulation | 23 Jul, 2024 | Granted | 18 Jun, 2038 | |
| {"application_id":"164465","ingredient":"PYRIDOSTIGMINE BROMIDE","trade_name":"PYRIDOSTIGMINE BROMIDE","family_id":"","publication_number":"US12233166B2","cleaned_patent_number":"12233166","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-18","publication_date":"2025-02-25","legal_status":"Granted"} | US12233166B2 Formulation | 25 Feb, 2025 | Granted | 18 Jun, 2038 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.