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Phenylephrine hydrochlorideis the generic ingredient in ten branded drugs marketed by Akorn, Paragon Bioteck, Eton Pharms, Accord Hlthcare, Amneal, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Par Sterile Products, Provepharm Sas, Sagent Pharms Inc, Sandoz Inc, Exela Pharma, Ani Pharms, Pharm Assoc, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, Wockhardt, and Allergan, and is included in twenty-nine 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. Eighteen suppliers are listed for this compound.
Summary for phenylephrine hydrochloride
|Drug Master File Entries:||21|
|Finished Product Suppliers / Packagers:||18|
|Raw Ingredient (Bulk) Api Vendors:||69|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for phenylephrine hydrochloride|
|What excipients (inactive ingredients) are in phenylephrine hydrochloride?||phenylephrine hydrochloride excipients list|
|DailyMed Link:||phenylephrine hydrochloride at DailyMed|
Recent Clinical Trials for phenylephrine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Rabin Medical Center||N/A|
|Laval University||Phase 3|
|CHU de Quebec-Universite Laval||Phase 3|
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||92923||Luxembourg||Get Started Free||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|
|1534313||2015/071||Ireland||Get Started Free||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||15C0090||France||Get Started Free||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|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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