AMIODARONE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Amiodarone Hydrochloride, and what generic alternatives are available?
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, Zhejiang Poly Pharm, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Norvium Bioscience, Rubicon, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc. and is included in thirty-one NDAs.
The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-three 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.
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Questions you can ask:
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Summary for AMIODARONE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 26 |
| NDAs: | 31 |
| Finished Product Suppliers / Packagers: | 30 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 161 |
| Patent Applications: | 793 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMIODARONE HYDROCHLORIDE |
| DailyMed Link: | AMIODARONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for AMIODARONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| OHSU Knight Cancer Institute | Phase 2 |
| Kun Hua | Phase 4 |
| Rush University Medical Center | N/A |
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 | 079029-001 | Sep 16, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 075424-001 | Mar 30, 2001 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rubicon | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 078578-002 | Feb 26, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Taro | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 076362-002 | Dec 2, 2003 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rubicon | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 078578-001 | Nov 6, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
