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esmolol hydrochloride in plastic container Drug Profile
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Which patents cover Esmolol Hydrochloride In Plastic Container, and what generic alternatives are available?
Esmolol Hydrochloride In Plastic Container is a drug marketed by Hq Spclt Pharma and is included in one NDA. There are four patents protecting this drug.
This drug has forty-five patent family members in twenty-five countries.
The generic ingredient in ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER is esmolol hydrochloride. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the esmolol hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Esmolol Hydrochloride In Plastic Container
A generic version of esmolol hydrochloride in plastic container was approved as esmolol hydrochloride by WEST-WARD PHARMS INT on August 10th, 2004.
Summary for esmolol hydrochloride in plastic container
| International Patents: | 45 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 90 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | esmolol hydrochloride in plastic container at DailyMed |
Recent Clinical Trials for esmolol hydrochloride in plastic container
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tianjin Nankai Hospital | N/A |
| CMC Ambroise Paré | Phase 3 |
| National Cancer Institute, Egypt | Early Phase 1 |
See all esmolol hydrochloride in plastic container clinical trials
Pharmacology for esmolol hydrochloride in plastic container
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
US Patents and Regulatory Information for esmolol hydrochloride in plastic container
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-001 | Apr 7, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-001 | Apr 7, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-001 | Apr 7, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | esmolol hydrochloride | SOLUTION;INTRAVENOUS | 205703-001 | Apr 7, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for esmolol hydrochloride in plastic container
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100889090 | Start Trial |
| Russian Federation | 2286774 | Start Trial |
| Czech Republic | 20023825 | Start Trial |
| Australia | 2002309475 | Start Trial |
| Canada | 2906031 | Start Trial |
| Turkey | 200202557 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
