NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 28 pharmaceutical companies such as HALEON US HOLDINGS, HIKMA, PARAGON BIOTECK and others. It is marketed under 15 brand names, including ADVIL CONGESTION RELIEF, ADVIL ALLERGY AND CONGESTION RELIEF, PHENYLEPHRINE HYDROCHLORIDE and others. Available in 14 different strengths, such as 200MG;10MG, 4MG;200MG;10MG, 10MG/ML (10MG/ML) and others, and administered through 6 routes including TABLET;ORAL, SOLUTION;INTRAVENOUS, SOLUTION/DROPS;OPHTHALMIC and others.
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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":"116186","ingredient":"PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE","trade_name":"MYDCOMBI","family_id":"f61b7dcd749e447eb49f","publication_number":"US11839487B2","cleaned_patent_number":"11839487","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-07-15","publication_date":"2023-12-12","legal_status":"Granted"} | US11839487B2 | 12 Dec, 2023 | Granted | 15 Jul, 2031 | |
| {"application_id":"116179","ingredient":"PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE","trade_name":"MYDCOMBI","family_id":"f61b7dcd749e447eb49f","publication_number":"US10839960B2","cleaned_patent_number":"10839960","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-07-15","publication_date":"2020-11-17","legal_status":"Granted"} | US10839960B2 | 17 Nov, 2020 | Granted | 15 Jul, 2031 | |
| {"application_id":"116139","ingredient":"PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE","trade_name":"MYDCOMBI","family_id":"f61b7dcd749e447eb49f","publication_number":"US11398306B2","cleaned_patent_number":"11398306","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-07-15","publication_date":"2022-07-26","legal_status":"Granted"} | US11398306B2 | 26 Jul, 2022 | Granted | 15 Jul, 2031 | |
| {"application_id":"2437","ingredient":"KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE","trade_name":"OMIDRIA","family_id":"278e3acd62c14517a5fc","publication_number":"US9855246B2","cleaned_patent_number":"9855246","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-10-23","publication_date":"2018-01-02","legal_status":"Granted"} | US9855246B2 Formulation | 02 Jan, 2018 | Granted | 23 Oct, 2033 | |
| {"application_id":"70829","ingredient":"PHENYLEPHRINE HYDROCHLORIDE","trade_name":"PHENYLEPHRINE HYDROCHLORIDE","family_id":"97a6fc1bb1e54b838ac5","publication_number":"US8859623B1","cleaned_patent_number":"8859623","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-11-14","publication_date":"2014-10-14","legal_status":"Granted"} | US8859623B2 | 14 Oct, 2014 | Granted | 14 Nov, 2033 | |
| {"application_id":"2441","ingredient":"KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE","trade_name":"OMIDRIA","family_id":"278e3acd62c14517a5fc","publication_number":"US9066856B2","cleaned_patent_number":"9066856","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-23","publication_date":"2015-06-30","legal_status":"Granted"} | US9066856B2 | 30 Jun, 2015 | Granted | 23 Apr, 2034 | |
| {"application_id":"2444","ingredient":"KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE","trade_name":"OMIDRIA","family_id":"278e3acd62c14517a5fc","publication_number":"US9486406B2","cleaned_patent_number":"9486406","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-23","publication_date":"2016-11-08","legal_status":"Granted"} | US9486406B2 | 08 Nov, 2016 | Granted | 23 Apr, 2034 | |
| {"application_id":"111790","ingredient":"PHENYLEPHRINE HYDROCHLORIDE","trade_name":"IMMPHENTIV","family_id":"be0f7a2ba7eb4b11b2f2","publication_number":"US11471400B2","cleaned_patent_number":"11471400","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-08-05","publication_date":"2022-10-18","legal_status":"Granted"} | US11471400B2 Formulation | 18 Oct, 2022 | Granted | 05 Aug, 2036 | |
| {"application_id":"111791","ingredient":"PHENYLEPHRINE HYDROCHLORIDE","trade_name":"IMMPHENTIV","family_id":"be0f7a2ba7eb4b11b2f2","publication_number":"US2023014425A1","cleaned_patent_number":"12257342","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-26","publication_date":"2023-01-19","legal_status":"Granted"} | US12257342B2 Formulation | 19 Jan, 2023 | Granted | 26 Sep, 2036 | |
| {"application_id":"111789","ingredient":"PHENYLEPHRINE HYDROCHLORIDE","trade_name":"IMMPHENTIV","family_id":"be0f7a2ba7eb4b11b2f2","publication_number":"US11213480B1","cleaned_patent_number":"11213480","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-26","publication_date":"2022-01-04","legal_status":"Granted"} | US11213480B2 Formulation | 04 Jan, 2022 | Granted | 26 Sep, 2036 |
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.