NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as SALIX. It is marketed under 1 brand name, including TRULANCE. Available in 1 different strength, such as 3MG, and administered through 1 route including TABLET;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 |
|---|
Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"101467","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"86030504941648f7866b","publication_number":"US7041786B2","cleaned_patent_number":"7041786","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-30","publication_date":"2006-05-09","legal_status":"Expired"} | US7041786B2 Molecular | 09 May, 2006 | Expired | 30 Jan, 2028 | |
| {"application_id":"35313","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"93b6ff73e2004b86b38e","publication_number":"US9925231B2","cleaned_patent_number":"9925231","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-15","publication_date":"2018-03-27","legal_status":"Granted"} | US9925231B2 Formulation | 27 Mar, 2018 | Granted | 15 Sep, 2031 | |
| {"application_id":"35311","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"93b6ff73e2004b86b38e","publication_number":"US9610321B2","cleaned_patent_number":"9610321","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-15","publication_date":"2017-04-04","legal_status":"Granted"} | US9610321B2 | 04 Apr, 2017 | Granted | 15 Sep, 2031 | |
| {"application_id":"35312","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"93b6ff73e2004b86b38e","publication_number":"US9919024B2","cleaned_patent_number":"9919024","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-15","publication_date":"2018-03-20","legal_status":"Granted"} | US9919024B2 | 20 Mar, 2018 | Granted | 15 Sep, 2031 | |
| {"application_id":"101494","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"605755c09cc845519445","publication_number":"US11319346B2","cleaned_patent_number":"11319346","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-01","publication_date":"2022-05-03","legal_status":"Granted"} | US11319346B2 Formulation | 03 May, 2022 | Granted | 01 Mar, 2032 | |
| {"application_id":"35310","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"93b6ff73e2004b86b38e","publication_number":"US9616097B2","cleaned_patent_number":"9616097","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-20","publication_date":"2017-04-11","legal_status":"Granted"} | US9616097B2 Formulation | 11 Apr, 2017 | Granted | 20 Aug, 2032 | |
| {"application_id":"138542","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"605755c09cc845519445","publication_number":"","cleaned_patent_number":"12146003","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-05","publication_date":"2024-11-19","legal_status":"Patented case"} | US12146003B2 Formulation | 19 Nov, 2024 | Patented case | 05 Jun, 2034 | |
| {"application_id":"101479","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"605755c09cc845519445","publication_number":"US11142549B2","cleaned_patent_number":"11142549","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-05","publication_date":"2021-10-12","legal_status":"Granted"} | US11142549B2 Formulation | 12 Oct, 2021 | Granted | 05 Jun, 2034 | |
| {"application_id":"101492","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"605755c09cc845519445","publication_number":"US10011637B2","cleaned_patent_number":"10011637","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-05","publication_date":"2018-07-03","legal_status":"Granted"} | US10011637B2 Molecular | 03 Jul, 2018 | Granted | 05 Jun, 2034 | |
| {"application_id":"121263","ingredient":"PLECANATIDE","trade_name":"TRULANCE","family_id":"605755c09cc845519445","publication_number":"US11834521B2","cleaned_patent_number":"11834521","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-06-05","publication_date":"2023-12-05","legal_status":"Granted"} | US11834521B2 Formulation | 05 Dec, 2023 | Granted | 05 Jun, 2034 |
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.