Dexmedetomidine Hydrochloride Patent Expiration

Dexmedetomidine Hydrochloride was first introduced by Hospira Inc in its drug Precedex on Dec 17, 1999. Other drugs containing Dexmedetomidine Hydrochloride are Igalmi, Dexmedetomidine Hydrochloride. 27 different companies have introduced drugs containing Dexmedetomidine Hydrochloride.


Dexmedetomidine Hydrochloride Patents

Given below is the list of patents protecting Dexmedetomidine 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
Igalmi US11806334 Non-sedating dexmedetomidine treatment regimens Jan 12, 2043 Bioxcel
Igalmi US11998528 Non-sedating dexmedetomidine treatment regimens Jan 12, 2043 Bioxcel
Igalmi US12090140 Non-sedating dexmedetomidine treatment regimens Jan 12, 2043 Bioxcel
Igalmi US12138247 Non-sedating dexmedetomidine treatment regimens Jan 12, 2043 Bioxcel
Igalmi US11890272 Non-sedating dexmedetomidine treatment regimens Jul 17, 2040 Bioxcel
Igalmi US11998529 Non-sedating dexmedetomidine treatment regimens Jul 17, 2040 Bioxcel
Igalmi US12109196 Non-sedating dexmedetomidine treatment regimens Jul 17, 2040 Bioxcel
Igalmi US10792246 Film formulations containing dexmedetomidine and methods of producing them Jun 26, 2039 Bioxcel
Igalmi US11478422 Film formulations containing dexmedetomidine and methods of producing them Jun 26, 2039 Bioxcel
Igalmi US11497711 Film formulations containing dexmedetomidine and methods of producing them Jun 26, 2039 Bioxcel
Igalmi US11517524 Film formulations containing dexmedetomidine and methods of producing them Jun 26, 2039 Bioxcel
Igalmi US11786508 Use of sublingual dexmedetomidine for the treatment of agitation Dec 29, 2037 Bioxcel
Igalmi US11839604 Use of sublingual dexmedetomidine for the treatment of agitation Dec 29, 2037 Bioxcel
Dexmedetomidine Hydrochloride US9649296 Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container Apr 20, 2036 Hq Spclt Pharma
Dexmedetomidine Hydrochloride US9717796 Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container Apr 20, 2036 Hq Spclt Pharma
Precedex US8242158

(Pediatric)

Dexmedetomidine premix formulation Jul 04, 2032 Hospira
Precedex US8338470

(Pediatric)

Dexmedetomidine premix formulation Jul 04, 2032 Hospira
Precedex US8455527

(Pediatric)

Methods of treatment using a dexmedetomidine premix formulation Jul 04, 2032 Hospira
Precedex US8648106

(Pediatric)

Dexmedetomidine premix formulation Jul 04, 2032 Hospira
Precedex US9320712

(Pediatric)

Dexmedetomidine premix formulation Jul 04, 2032 Hospira
Precedex US9616049

(Pediatric)

Dexmedetomidine premix formulation Jul 04, 2032 Hospira
Precedex US10016396 Dexmedetomidine premix formulation Jan 04, 2032 Hospira
Precedex US8242158 Dexmedetomidine premix formulation Jan 04, 2032 Hospira
Precedex US8338470 Dexmedetomidine premix formulation Jan 04, 2032 Hospira
Precedex US8455527 Methods of treatment using a dexmedetomidine premix formulation Jan 04, 2032 Hospira
Precedex US8648106 Dexmedetomidine premix formulation Jan 04, 2032 Hospira
Precedex US9320712 Dexmedetomidine premix formulation Jan 04, 2032 Hospira
Precedex US9616049 Dexmedetomidine premix formulation Jan 04, 2032 Hospira
Precedex US6716867

(Pediatric)

Use of dexmedetomidine for ICU sedation Oct 01, 2019

(Expired)

Hospira
Precedex US6716867 Use of dexmedetomidine for ICU sedation Mar 31, 2019

(Expired)

Hospira
Precedex US4910214

(Pediatric)

Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist Jan 15, 2014

(Expired)

Hospira
Precedex US4910214 Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist Jul 15, 2013

(Expired)

Hospira



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 Dexmedetomidine Hydrochloride's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Yr, Small Entity 20 Jan, 2021 US9717796
Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 09 Oct, 2020 US9717796
Payment of Maintenance Fee, 4th Yr, Small Entity 24 Sep, 2020 US9649296
Patent Issue Date Used in PTA Calculation 01 Aug, 2017 US9717796
Recordation of Patent Grant Mailed 01 Aug, 2017 US9717796
Application ready for PDX access by participating foreign offices 13 Jul, 2017 US9717796
Email Notification 13 Jul, 2017 US9717796
Issue Notification Mailed 12 Jul, 2017 US9717796
Dispatch to FDC 28 Jun, 2017 US9717796
Application Is Considered Ready for Issue 27 Jun, 2017 US9717796


Dexmedetomidine Hydrochloride's Family Patents

Family Patents

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Dexmedetomidine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Dexmedetomidine Hydrochloride. The first generic version for Dexmedetomidine Hydrochloride was by Mylan Institutional Llc and was approved on Aug 18, 2014. And the latest generic version is by Hikma Pharmaceuticals Usa Inc and was approved on May 30, 2025.

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