Phenylephrine Hydrochloride Patent Expiration

Phenylephrine Hydrochloride was first introduced by Hikma Pharmaceuticals Usa Inc in its drug Phenylephrine Hydrochloride on Dec 20, 2012. Other drugs containing Phenylephrine Hydrochloride are Vazculep, Immphentiv, Phenylephrine Hydrochloride In 0.9% Sodium Chloride, Biorphen. 22 different companies have introduced drugs containing Phenylephrine Hydrochloride.


Phenylephrine Hydrochloride Patents

Given below is the list of patents protecting Phenylephrine Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Immphentiv US11213480 Phenylephrine hydrochloride ready-to-use solution Sep 26, 2036 Hikma
Immphentiv US12257342 Phenylephrine hydrochloride ready-to-use solution Sep 26, 2036 Hikma
Immphentiv US11471400 Phenylephrine hydrochloride ready-to-use solution Aug 05, 2036 Hikma
Phenylephrine Hydrochloride US8859623 Methods and compositions of stable phenylephrine formulations Nov 14, 2033 Paragon Bioteck



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Phenylephrine Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Phenylephrine Hydrochloride.

Activity Date Patent Number
Patent litigations
7.5 yr surcharge - late pmt w/in 6 mo, Large Entity 03 Oct, 2022 US8859623
Payment of Maintenance Fee, 8th Year, Large Entity 03 Oct, 2022 US8859623
Application Return from OIPE 18 Jul, 2022 US8859623
Correspondence Address Change 18 Jul, 2022 US8859623
Application Return TO OIPE 18 Jul, 2022 US8859623
Maintenance Fee Reminder Mailed 06 Jun, 2022 US8859623
Appeal to Court of Appeals 13 Jan, 2017 US8859623
Termination or Final Written Decision 14 Nov, 2016 US8859623
Application ready for PDX access by participating foreign offices 31 Aug, 2015 US8859623
Petition Requesting Trial 11 May, 2015 US8859623


Phenylephrine Hydrochloride's Family Patents

Family Patents

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Phenylephrine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Phenylephrine Hydrochloride. The first generic version for Phenylephrine Hydrochloride was by Meitheal Pharmaceuticals Inc and was approved on Apr 27, 2018. And the latest generic version is by Somerset Therapeutics Llc and was approved on Feb 14, 2025.

Given below is the list of companies who have filed for Phenylephrine Hydrochloride generic, along with the locations of their manufacturing plants worldwide.