ESMOLOL HYDROCHLORIDE Drug Patent Profile
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When do Esmolol Hydrochloride patents expire, and what generic alternatives are available?
Esmolol Hydrochloride is a drug marketed by Am Regent, Amneal, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Mylan Institutional, Mylan Labs Ltd, and Sagent Pharms Inc. and is included in twelve NDAs. There are two patents protecting this drug.
The generic ingredient in ESMOLOL HYDROCHLORIDE is esmolol hydrochloride. There are eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Esmolol Hydrochloride
A generic version of ESMOLOL HYDROCHLORIDE was approved as esmolol hydrochloride by HIKMA on August 10th, 2004.
Summary for ESMOLOL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 96 |
| Clinical Trials: | 109 |
| Patent Applications: | 703 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESMOLOL HYDROCHLORIDE |
| What excipients (inactive ingredients) are in ESMOLOL HYDROCHLORIDE? | ESMOLOL HYDROCHLORIDE excipients list |
| DailyMed Link: | ESMOLOL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ESMOLOL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | Phase 3 |
| Instituto de Salud Carlos III | Phase 3 |
| Xiumei Song | Phase 4 |
Pharmacology for ESMOLOL HYDROCHLORIDE
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ESMOLOL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ESMOLOL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BREVIBLOC IN PLASTIC CONTAINER | Injection | esmolol hydrochloride | 10 mg/mL, 250 mL infusion bags and 20 mg/mL, 100 mL infusion bags | 019386 | 1 | 2014-01-31 |
US Patents and Regulatory Information for ESMOLOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 201126-001 | Feb 20, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-002 | Apr 7, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 076573-001 | May 2, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eugia Pharma | ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 216244-001 | Mar 21, 2022 | AP | 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 |
