DRONEDARONE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Dronedarone Hydrochloride, and when can generic versions of Dronedarone Hydrochloride launch?
Dronedarone Hydrochloride is a drug marketed by Lupin and is included in one NDA.
The generic ingredient in DRONEDARONE HYDROCHLORIDE is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dronedarone Hydrochloride
A generic version of DRONEDARONE HYDROCHLORIDE was approved as dronedarone hydrochloride by LUPIN on January 31st, 2024.
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Summary for DRONEDARONE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 34 |
| Patent Applications: | 117 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DRONEDARONE HYDROCHLORIDE |
| DailyMed Link: | DRONEDARONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DRONEDARONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai East Hospital | Phase 4 |
| Stony Brook University | Phase 3 |
| Chinese Academy of Medical Sciences, Fuwai Hospital | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for DRONEDARONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DRONEDARONE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MULTAQ | Tablets | dronedarone hydrochloride | 400 mg | 022425 | 7 | 2013-07-01 |
US Patents and Regulatory Information for DRONEDARONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | DRONEDARONE HYDROCHLORIDE | dronedarone hydrochloride | TABLET;ORAL | 205904-001 | Jan 31, 2024 | 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 |
