Amiodarone Hydrochloride Patent Expiration
Amiodarone Hydrochloride was first introduced by Wyeth Pharmaceuticals Llc
Amiodarone Hydrochloride Patents
Given below is the list of patents protecting Amiodarone 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 |
|---|---|---|---|---|
| Nexterone | US6869939 | Formulations containing amiodarone and sulfoalkyl ether cyclodextrin |
May 04, 2022
(Expired) | Baxter Hlthcare |
| Nexterone | US7635773 | Sulfoalkyl ether cyclodextrin compositions | Mar 13, 2029 | Baxter Hlthcare |
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Amiodarone Hydrochloride Generics
Several generic applications have been filed for Amiodarone Hydrochloride. The first generic version for Amiodarone Hydrochloride was by Upsher Smith Laboratories Llc and was approved on Apr 30, 1998. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Jan 6, 2023.
Given below is the list of companies who have filed for Amiodarone Hydrochloride generic.
1. TARO
Taro Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Taro.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG
(reference standard) | tablet | Prescription | ORAL | AB | Mar 30, 2001 |
| 400MG | tablet | Prescription | ORAL | AB | Nov 29, 2002 |
| 100MG | tablet | Prescription | ORAL | AB | Dec 18, 2002 |
| 300MG | tablet | Prescription | ORAL | N/A | Dec 2, 2003 |
2. TEVA
Teva Pharmaceuticals Usa Inc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Discontinued | ORAL | N/A | Apr 16, 1999 |
3. UNICHEM
Unichem Laboratories Ltd has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Unichem.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Prescription | ORAL | AB | Jul 21, 2020 |
4. HIKMA FARMACEUTICA
Hikma Farmaceutica (portugal) Sa has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma Farmaceutica.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Prescription | INJECTION | AP | Feb 25, 2008 |
5. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 1 generic for Amiodarone 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 |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 25, 2017 |
6. BEDFORD LABS
Bedford Laboratories has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Bedford Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 24, 2002 |
7. ACELLA
Acella Pharmaceuticals Llc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Acella.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Prescription | INJECTION | AP | Oct 30, 2008 |
8. ZYDUS PHARMS USA INC
Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Prescription | ORAL | AB | Sep 16, 2008 |
| 400MG | tablet | Prescription | ORAL | AB | Jan 6, 2023 |
| 100MG | tablet | Prescription | ORAL | AB | Jan 6, 2023 |
9. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 1 generic for Amiodarone 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 |
|---|---|---|---|---|---|
| 50MG/ML
(reference standard) | injectable | Prescription | INJECTION | AP | Apr 20, 2005 |
10. BEN VENUE
Ben Venue Laboratories Inc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Ben Venue.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 15, 2002 |
11. DR REDDYS LABS SA
Dr Reddys Laboratories Sa has filed for 3 different strengths of generic version for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Prescription | ORAL | AB | Jan 25, 2001 |
| 400MG | tablet | Prescription | ORAL | AB | Dec 28, 2017 |
| 100MG | tablet | Prescription | ORAL | AB | Dec 28, 2017 |
12. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Rx.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 400MG | tablet | Prescription | ORAL | AB | Apr 8, 2005 |
| 200MG | tablet | Prescription | ORAL | AB | Apr 8, 2005 |
| 100MG | tablet | Prescription | ORAL | AB | Oct 4, 2016 |
13. BEDFORD
Bedford Laboratories Div Ben Venue Laboratories Inc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Bedford.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Oct 15, 2002 |
14. PAR STERILE PRODUCTS
Par Sterile Products Llc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Par Sterile Products.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Apr 25, 2003 |
15. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Amiodarone 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 |
|---|---|---|---|---|---|
| 50MG/ML
(reference standard) | injectable | Prescription | INJECTION | AP | Oct 15, 2002 |
16. RUBICON
Rubicon Research Private Ltd has filed for 3 different strengths of generic version for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Rubicon.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Prescription | ORAL | AB | Nov 6, 2008 |
| 400MG | tablet | Prescription | ORAL | AB | Feb 26, 2021 |
| 100MG | tablet | Prescription | ORAL | AB | Feb 26, 2021 |
17. MYLAN
Mylan Pharmaceuticals Inc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Discontinued | ORAL | N/A | Feb 24, 1999 |
18. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Sep 5, 2003 |
19. UPSHER SMITH LABS
Upsher Smith Laboratories Llc has filed for 3 different strengths of generic version for Amiodarone Hydrochloride. Out of these 400mg version comes by the name PACERONE, 100mg version comes by the name PACERONE. Given below are the details of the strengths of this generic introduced by Upsher Smith Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Discontinued | ORAL | N/A | Dec 23, 1998 |
| 400MG | tablet | Prescription | ORAL | AB | Jul 2, 2020 |
| 100MG | tablet | Prescription | ORAL | AB | Apr 12, 2005 |
20. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Prescription | ORAL | AB | Nov 30, 1998 |
21. HOSPIRA
Hospira Inc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Nov 25, 2013 |
22. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG | tablet | Prescription | ORAL | AB | Jun 3, 2016 |
23. MYLAN INSTITUTIONAL
Mylan Institutional Llc has filed for 1 generic for Amiodarone 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 |
|---|---|---|---|---|---|
| 50MG/ML
(reference standard) | injectable | Prescription | INJECTION | AP | Oct 15, 2002 |
24. EPIC PHARMA LLC
Epic Pharma Llc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Jul 5, 2006 |