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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 Dexmedetomidine Hydrochloride, Igalmi. 28 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 US11890272 Non-sedating dexmedetomidine treatment regimens Jul 17, 2040 Bioxcel
Igalmi US11998529 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
Critical
 01 Aug, 2017 US9717796
Recordation of Patent Grant Mailed
Critical
 01 Aug, 2017 US9717796
Application ready for PDX access by participating foreign offices
Critical
 13 Jul, 2017 US9717796
Email Notification
Critical
 13 Jul, 2017 US9717796
Issue Notification Mailed
Critical
 12 Jul, 2017 US9717796
Dispatch to FDC 28 Jun, 2017 US9717796
Application Is Considered Ready for Issue
Critical
 27 Jun, 2017 US9717796


Dexmedetomidine Hydrochloride's Family Patents

Family Patents

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Dexmedetomidine Hydrochloride Generics

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 Somerset Therapeutics Llc and was approved on Sep 24, 2024.

Given below is the list of companies who have filed for Dexmedetomidine Hydrochloride generic.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Feb 9, 2016


2. ACTAVIS INC

Actavis Inc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Oct 17, 2016


3. AM REGENT

American Regent Inc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Discontinued INJECTION N/A May 12, 2017


4. AMNEAL

Amneal Eu Ltd has filed for 2 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP May 15, 2023
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP May 15, 2023


5. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 2 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP May 20, 2020
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP May 20, 2020


6. BAXTER HLTHCARE CORP

Baxter Healthcare Corp has filed for 2 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Baxter Hlthcare Corp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Aug 21, 2018
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Aug 21, 2018


7. ENDO OPERATIONS

Endo Operations Ltd has filed for 3 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Aug 18, 2014
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Sep 15, 2020
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Sep 15, 2020


8. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 3 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Mar 17, 2016
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Dec 7, 2020
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Dec 7, 2020


9. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 4 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Sep 18, 2015
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Nov 29, 2018
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Nov 29, 2018
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Nov 29, 2018


10. GLAND

Gland Pharma Ltd has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Gland.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Aug 20, 2015


11. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 2 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jun 3, 2020
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jun 3, 2020


12. HENGRUI PHARMA

Jiangsu Hengrui Pharmaceuticals Co Ltd has filed for 4 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hengrui Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Sep 19, 2017
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jun 12, 2020
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jun 12, 2020
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jun 12, 2020


13. HIKMA

Hikma Pharmaceuticals International Ltd has filed for 3 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Apr 26, 2017
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jan 30, 2020
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jan 30, 2020


14. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Jan 18, 2019


15. MILLA PHARMS

Milla Pharmaceuticals Inc has filed for 2 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Milla Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jun 7, 2023
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Jun 7, 2023


16. MYLAN INSTITUTIONAL

Mylan Institutional Llc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Aug 18, 2014


17. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 2 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Aug 27, 2020
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Aug 27, 2020


18. PIRAMAL CRITICAL

Piramal Critical Care Inc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Piramal Critical.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Discontinued INJECTION N/A Sep 3, 2021


19. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Nov 24, 2014


20. SANDOZ

Sandoz Inc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Jun 14, 2016


21. SOMERSET

Somerset Therapeutics Llc has filed for 2 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Somerset.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) solution Prescription INTRAVENOUS AP Sep 24, 2024
EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) solution Prescription INTRAVENOUS AP Sep 24, 2024


22. TAGI

Tagi Pharma Inc has filed for 3 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Tagi.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Nov 23, 2020
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Nov 23, 2020
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Nov 23, 2020


23. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Nov 28, 2017


24. WILSHIRE PHARMS INC

Wilshire Pharmaceuticals Inc has filed for 3 different strengths of generic version for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Wilshire Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Dec 4, 2019
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) injectable Prescription INJECTION AP Dec 4, 2019
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) injectable Discontinued INJECTION N/A May 8, 2020


25. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Dexmedetomidine Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) injectable Prescription INJECTION AP Feb 27, 2018