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Phenylephrine hydrochlorideis the generic ingredient in ten branded drugs marketed by Akorn Inc, Paragon Bioteck, Eton Pharms, Amneal, Fresenius Kabi Usa, Meitheal, Par Sterile Products, Riconpharma Llc, Sandoz Inc, West Ward Pharm Corp, Avadel Legacy, Ani Pharms, Hi Tech, Vintage, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, Wockhardt, and Allergan, and is included in twenty-three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.
Phenylephrine hydrochloride has one patent family member in one country.
There are twenty-one drug master file entries for phenylephrine hydrochloride. Fifteen suppliers are listed for this compound.
Summary for phenylephrine hydrochloride
|Drug Master File Entries:||21|
|Suppliers / Packagers:||15|
|Bulk Api Vendors:||65|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for phenylephrine hydrochloride|
|DailyMed Link:||phenylephrine hydrochloride at DailyMed|
Recent Clinical Trials for phenylephrine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Helse Fonna||Phase 4|
|University of Missouri-Columbia||Early Phase 1|
Pharmacology for phenylephrine hydrochloride
|Drug Class||alpha-1 Adrenergic Agonist |
|Mechanism of Action||Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for phenylephrine hydrochloride
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1534313||15C0090||France||Start Trial||PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728|
|1534313||2015/071||Ireland||Start Trial||PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728|
|1534313||92923||Luxembourg||Start Trial||PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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