NDA (New Drug Application)
ANDA (Generic Application)
It is formulated by 19 pharmaceutical companies such as DR REDDYS LABS LTD, AVANTHI INC, EXELA PHARMA and others. It is marketed under 7 brand names, including DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, AKOVAZ and others. Available in 6 different strengths, such as 5MG;240MG, 6MG;120MG, 50MG/ML (50MG/ML) and others, and administered through 2 routes including TABLET, EXTENDED RELEASE;ORAL, SOLUTION;INTRAVENOUS.
Track protection status across key markets to assess launch feasibility.
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Licensing: 19 potential partnersUS Launch window: Loading launch window...
FDA approval history for this ingredient
Key expiration dates for US patents covering this ingredient
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":"73547","ingredient":"EPHEDRINE SULFATE","trade_name":"EPHEDRINE SULFATE","family_id":"cd9a6790791545848f6d","publication_number":"US10869845B1","cleaned_patent_number":"10869845","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-01-22","publication_date":"2020-12-22","legal_status":"Granted"} | US10869845B2 Formulation | 22 Dec, 2020 | Granted | 22 Jan, 2040 | |
| {"application_id":"124164","ingredient":"EPHEDRINE SULFATE","trade_name":"EPHEDRINE SULFATE","family_id":"","publication_number":"US12029710B2","cleaned_patent_number":"12029710","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-01-22","publication_date":"2024-07-09","legal_status":"Granted"} | US12029710B2 | 09 Jul, 2024 | Granted | 22 Jan, 2040 | |
| {"application_id":"73542","ingredient":"EPHEDRINE SULFATE","trade_name":"EMERPHED","family_id":"11c3f74c5f1a473c9750","publication_number":"US11241400B2","cleaned_patent_number":"11241400","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-05-16","publication_date":"2022-02-08","legal_status":"Granted"} | US11241400B2 | 08 Feb, 2022 | Granted | 16 May, 2040 | |
| {"application_id":"108550","ingredient":"EPHEDRINE SULFATE","trade_name":"EMERPHED","family_id":"62b7da260874470c8e6c","publication_number":"US11478436B2","cleaned_patent_number":"11478436","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-05-16","publication_date":"2022-10-25","legal_status":"Granted"} | US11478436B2 | 25 Oct, 2022 | Granted | 16 May, 2040 | |
| {"application_id":"111315","ingredient":"EPHEDRINE SULFATE","trade_name":"EMERPHED","family_id":"dd3fe95691604347a62a","publication_number":"US11571398B2","cleaned_patent_number":"11571398","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-05-16","publication_date":"2023-02-07","legal_status":"Granted"} | US11571398B2 | 07 Feb, 2023 | Granted | 16 May, 2040 | |
| {"application_id":"73543","ingredient":"EPHEDRINE SULFATE","trade_name":"EMERPHED","family_id":"62b7da260874470c8e6c","publication_number":"US11464752B2","cleaned_patent_number":"11464752","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-05-16","publication_date":"2022-10-11","legal_status":"Granted"} | US11464752B2 Formulation | 11 Oct, 2022 | Granted | 16 May, 2040 | |
| {"application_id":"73534","ingredient":"EPHEDRINE SULFATE","trade_name":"EMERPHED","family_id":"11c3f74c5f1a473c9750","publication_number":"US11090278B2","cleaned_patent_number":"11090278","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-05-16","publication_date":"2021-08-17","legal_status":"Granted"} | US11090278B2 | 17 Aug, 2021 | Granted | 16 May, 2040 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.