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Amiodarone Hydrochloride Patent Expiration

Amiodarone Hydrochloride was first introduced by Wyeth Pharmaceuticals Llc in its drug Cordarone on Dec 24, 1985. Other drugs containing Amiodarone Hydrochloride are Amiodarone Hydrochloride, Nexterone. 29 different companies have introduced drugs containing Amiodarone Hydrochloride.


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 US7635773 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Baxter Hlthcare
Nexterone US6869939 Formulations containing amiodarone and sulfoalkyl ether cyclodextrin May 04, 2022

(Expired)

 Baxter Hlthcare



Amiodarone Hydrochloride's Family Patents

Family Patents

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Amiodarone Hydrochloride Generic API Manufacturers

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 Zhejiang Poly Pharm Co Ltd and was approved on Sep 11, 2024.

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


1. 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


Manufacturing Plant Locations
New

Acella's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Acella as present at those locations.

Country City Firm Name
United States
Alpharetta Acella Pharmaceuticals, LLC





2. 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


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





3. 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


Manufacturing Plant Locations
New

Bedford's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bedford as present at those locations.

Country City Firm Name
United States
Curryville Bedford Farm Bureau Cooperative
Bedford Bedford Research Foundation, Inc.
Shelbyville Bedford Cheese Store Inc





4. 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





5. 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


Manufacturing Plant Locations
New

Ben Venue's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Ben Venue as present at those locations.

Country City Firm Name
United States
Bedford Ben Venue Laboratories Inc





6. 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
200MG

tablet Prescription ORAL AB Apr 8, 2005
400MG

tablet Prescription ORAL AB Apr 8, 2005
100MG

tablet Prescription ORAL AB Oct 4, 2016





7. 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





8. 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





9. 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





10. 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


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited





11. 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


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Bensenville Fresenius Kabi USA LLC (FK USA)
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC





12. 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





13. 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


Manufacturing Plant Locations
New

Hikma Farmaceutica's manufacturing plants are situated in 1 country - Portugal. Given below are the details of these plant locations as well as the firm names of Hikma Farmaceutica as present at those locations.

Country City Firm Name
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.





14. 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


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Lake Forest Hospira Inc
Clayton Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Rocky Mount Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





15. 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


Manufacturing Plant Locations
New

Mylan Institutional's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mylan Institutional as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.





16. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Feb 24, 1999





17. 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


Manufacturing Plant Locations
New

Par Sterile Products's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Par Sterile Products as present at those locations.

Country City Firm Name
United States
Parsippany Par Sterile Products LLC DBA JHP Pharmaceuticals, LLC





18. 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


Manufacturing Plant Locations
New

Rubicon's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Rubicon as present at those locations.

Country City Firm Name
United States
Indianapolis Rubicon Foods LLC
Geismar Rubicon, LLC
Canada
Concord Rubicon Research Canada Limited
India
Ambarnath Rubicon Research Private Limited





19. 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


Manufacturing Plant Locations
New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country City Firm Name
United States
Honolulu Taro Delight, LLC
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





20. 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


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Fort Dodge TEVA Animal Health Inc
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





21. 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





22. 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


Manufacturing Plant Locations
New

Unichem's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Unichem as present at those locations.

Country City Firm Name
India
Ghaziabad Unichem Laboratories Ltd.
Mumbai Unichem Laboratories Limited
Kolhapur Unichem Laboratories Limited
Pilerne Bardez Unichem Laboratories Limited
Pithampur Unichem Laboratories Limited
District Raigad Unichem Laboratories Ltd
United States
Hasbrouck Heights Unichem Pharmaceuticals Usa Inc
East Brunswick Unichem Pharmaceuticals USA Inc.





23. 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





24. ZHEJIANG POLY PHARM

Zhejiang Poly Pharm Co Ltd has filed for 1 generic for Amiodarone Hydrochloride. Given below are the details of the strengths of this generic introduced by Zhejiang Poly Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Prescription INJECTION AP Sep 11, 2024





25. 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