Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate Global Patent Coverage & Expiry Overview

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It is formulated by 3 pharmaceutical companies such as NOVEL LABS INC, SALIX, TARO. It is marketed under 2 brand names, including PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID, PLENVU. Available in 2 different strengths, such as 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM, 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM, and administered through 1 route including FOR SOLUTION;ORAL.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

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US Orange Book Patents Expiration Timeline

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"57333","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"10bd457cf9b34dfca2b4","publication_number":"US10780112B2","cleaned_patent_number":"10780112","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-09","publication_date":"2020-09-22","legal_status":"Granted"} US10780112B2 Formulation 22 Sep, 2020 Granted 09 Mar, 2032
{"application_id":"57334","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"10bd457cf9b34dfca2b4","publication_number":"US10792306B2","cleaned_patent_number":"10792306","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-09","publication_date":"2020-10-06","legal_status":"Granted"} US10792306B2 Formulation 06 Oct, 2020 Granted 09 Mar, 2032
{"application_id":"57335","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"505398a13d554884af68","publication_number":"US11529368B2","cleaned_patent_number":"11529368","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-09","publication_date":"2022-12-20","legal_status":"Granted"} US11529368B2 Formulation 20 Dec, 2022 Granted 09 Mar, 2032
{"application_id":"57332","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"10bd457cf9b34dfca2b4","publication_number":"US10646512B2","cleaned_patent_number":"10646512","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-25","publication_date":"2020-05-12","legal_status":"Granted"} US10646512B2 Formulation 12 May, 2020 Granted 25 Mar, 2032
{"application_id":"57278","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"10bd457cf9b34dfca2b4","publication_number":"US9592252B2","cleaned_patent_number":"9592252","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-11","publication_date":"2017-03-14","legal_status":"Granted"} US9592252B2 Formulation 14 Mar, 2017 Granted 11 Aug, 2032
{"application_id":"57267","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"2559cfb0916542578773","publication_number":"US10016504B2","cleaned_patent_number":"10016504","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-10","publication_date":"2018-07-10","legal_status":"Granted"} US10016504B2 Formulation 10 Jul, 2018 Granted 10 Sep, 2033
{"application_id":"57266","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"2559cfb0916542578773","publication_number":"US9707297B2","cleaned_patent_number":"9707297","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-10","publication_date":"2017-07-18","legal_status":"Granted"} US9707297B2 Formulation 18 Jul, 2017 Granted 10 Sep, 2033
{"application_id":"57268","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"2559cfb0916542578773","publication_number":"US10918723B2","cleaned_patent_number":"10918723","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-10","publication_date":"2021-02-16","legal_status":"Granted"} US10918723B2 16 Feb, 2021 Granted 10 Sep, 2033
{"application_id":"57272","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"2559cfb0916542578773","publication_number":"US20210346503A1","cleaned_patent_number":"12083179","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-10","publication_date":"2021-11-11","legal_status":"Granted"} US12083179B2 Formulation 11 Nov, 2021 Granted 10 Sep, 2033
{"application_id":"57265","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"2559cfb0916542578773","publication_number":"US8999313B2","cleaned_patent_number":"8999313","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-10","publication_date":"2015-04-07","legal_status":"Granted"} US8999313B2 Formulation 07 Apr, 2015 Granted 10 Sep, 2033
{"application_id":"57203","ingredient":"ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE","trade_name":"PLENVU","family_id":"2559cfb0916542578773","publication_number":"US9326969B2","cleaned_patent_number":"9326969","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-10","publication_date":"2016-05-03","legal_status":"Granted"} US9326969B2 03 May, 2016 Granted 10 Sep, 2033

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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.

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