Dexmedetomidine Hydrochloride Patent Expiration
Dexmedetomidine Hydrochloride was first introduced by Hospira Inc
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 |
|---|---|---|---|---|
| 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 |
| 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 | US11806334 | Non-sedating dexmedetomidine treatment regimens | Jan 12, 2043 | Bioxcel |
| Igalmi | US11839604 | Use of sublingual dexmedetomidine for the treatment of agitation | Dec 29, 2037 | Bioxcel |
| Igalmi | US11890272 | Non-sedating dexmedetomidine treatment regimens | Jul 17, 2040 | Bioxcel |
| Igalmi | US11998528 | Non-sedating dexmedetomidine treatment regimens | Jan 12, 2043 | Bioxcel |
| Igalmi | US11998529 | Non-sedating dexmedetomidine treatment regimens | Jul 17, 2040 | Bioxcel |
| Precedex | US10016396 | Dexmedetomidine premix formulation | Jan 04, 2032 | Hospira |
| Precedex | US4910214 | Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist |
Jul 15, 2013
(Expired) | Hospira |
| Precedex |
US4910214 (Pediatric) | Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist |
Jan 15, 2014
(Expired) | Hospira |
| Precedex | US6716867 | Use of dexmedetomidine for ICU sedation |
Mar 31, 2019
(Expired) | Hospira |
| Precedex |
US6716867 (Pediatric) | Use of dexmedetomidine for ICU sedation |
Oct 01, 2019
(Expired) | Hospira |
| Precedex | US8242158 | Dexmedetomidine premix formulation | Jan 04, 2032 | Hospira |
| Precedex |
US8242158 (Pediatric) | Dexmedetomidine premix formulation | Jul 04, 2032 | Hospira |
| Precedex | US8338470 | Dexmedetomidine premix formulation | Jan 04, 2032 | Hospira |
| Precedex |
US8338470 (Pediatric) | Dexmedetomidine premix formulation | Jul 04, 2032 | Hospira |
| Precedex | US8455527 | Methods of treatment using a dexmedetomidine premix formulation | Jan 04, 2032 | Hospira |
| Precedex |
US8455527 (Pediatric) | Methods of treatment using a dexmedetomidine premix formulation | Jul 04, 2032 | Hospira |
| Precedex | US8648106 | Dexmedetomidine premix formulation | Jan 04, 2032 | Hospira |
| Precedex |
US8648106 (Pediatric) | Dexmedetomidine premix formulation | Jul 04, 2032 | Hospira |
| Precedex | US9320712 | Dexmedetomidine premix formulation | Jan 04, 2032 | Hospira |
| Precedex |
US9320712 (Pediatric) | Dexmedetomidine premix formulation | Jul 04, 2032 | Hospira |
| Precedex | US9616049 | Dexmedetomidine premix formulation | Jan 04, 2032 | Hospira |
| Precedex |
US9616049 (Pediatric) | Dexmedetomidine premix formulation | Jul 04, 2032 | 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.
Latest Legal Activities on Dexmedetomidine Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Dexmedetomidine Hydrochloride.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 |
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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 Milla Pharmaceuticals Inc and was approved on Jun 7, 2023.
Given below is the list of companies who have filed for Dexmedetomidine Hydrochloride generic.
1. 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 200MCG BASE/50ML (EQ 4MCG BASE/ML) | injectable | Prescription | INJECTION | AP | Aug 27, 2020 |
| EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | injectable | Prescription | INJECTION | AP | Aug 27, 2020 |
2. 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 400MCG BASE/100ML (EQ 4MCG BASE/ML) | injectable | Prescription | INJECTION | AP | May 15, 2023 |
| EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | injectable | Prescription | INJECTION | AP | May 15, 2023 |
3. 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 |
4. 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 |
5. 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 |
6. 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 200MCG BASE/50ML (EQ 4MCG BASE/ML) | injectable | Prescription | INJECTION | AP | Jan 30, 2020 |
| EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | injectable | Prescription | INJECTION | AP | Jan 30, 2020 |
7. 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 |
8. 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 |
9. 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 |
10. 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 |
11. 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 |
12. 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 |
13. 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 |
14. 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 |
15. 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 |
16. 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 200MCG BASE/50ML (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 400MCG BASE/100ML (EQ 4MCG BASE/ML) | injectable | Prescription | INJECTION | AP | Nov 29, 2018 |
17. SLAYBACK PHARMA LLC
Slayback Pharma Llc 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 Slayback Pharma Llc.
| 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 |
18. 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 |
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. 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 |
21. 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 |
22. 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 |
23. 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 |
24. 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 |