AMIODARONE HYDROCHLORIDE Drug Patent Profile
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When do Amiodarone Hydrochloride patents expire, and when can generic versions of Amiodarone Hydrochloride launch?
Amiodarone Hydrochloride is a drug marketed by Acella, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Mylan, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc. and is included in thirty NDAs.
The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amiodarone Hydrochloride
A generic version of AMIODARONE HYDROCHLORIDE was approved as amiodarone hydrochloride by TEVA PHARMS on November 30th, 1998.
Summary for AMIODARONE HYDROCHLORIDE
Recent Clinical Trials for AMIODARONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Kun Hua | Phase 4 |
Rush University Medical Center | N/A |
Massachusetts General Hospital | Phase 4 |
Pharmacology for AMIODARONE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for AMIODARONE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for AMIODARONE HYDROCHLORIDE
US Patents and Regulatory Information for AMIODARONE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms Usa Inc | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 079029-003 | Jan 6, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Taro | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 076362-002 | Dec 2, 2003 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Rubicon | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 078578-001 | Nov 6, 2008 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Taro | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 076362-001 | Nov 29, 2002 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |