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ESMOLOL HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for esmolol hydrochloride and what is the scope of patent protection?
Esmolol hydrochloride
is the generic ingredient in six branded drugs marketed by Baxter Hlthcare, Am Regent, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Institutional, Mylan Labs Ltd, Sagent Pharms Inc, West-ward Pharms Int, and Hq Spclt Pharma, and is included in ten NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Esmolol hydrochloride has forty-five patent family members in twenty-five countries.
There are eight drug master file entries for esmolol hydrochloride. Eleven suppliers are listed for this compound.
Summary for ESMOLOL HYDROCHLORIDE
| International Patents: | 45 |
| US Patents: | 6 |
| Tradenames: | 6 |
| Applicants: | 10 |
| NDAs: | 10 |
| Drug Master File Entries: | 8 |
| Suppliers / Packagers: | 11 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 90 |
| Patent Applications: | 936 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESMOLOL HYDROCHLORIDE |
| DailyMed Link: | ESMOLOL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ESMOLOL HYDROCHLORIDE
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 |
Pharmacology for ESMOLOL HYDROCHLORIDE
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Paragraph IV (Patent) Challenges for ESMOLOL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
| BREVIBLOC IN PLASTIC CONTAINER | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
| BREVIBLOC | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sagent Pharms Inc | ESMOLOL HYDROCHLORIDE | esmolol hydrochloride | INJECTABLE;INJECTION | 207107-002 | Jun 8, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Baxter Hlthcare | BREVIBLOC IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-004 | Feb 16, 2001 | 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 | |||
| Baxter Hlthcare | BREVIBLOC IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-004 | Feb 16, 2001 | 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 |
Expired US Patents for ESMOLOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | BREVIBLOC IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-004 | Feb 16, 2001 | Start Trial | Start Trial |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-003 | Aug 15, 1988 | Start Trial | Start Trial |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-007 | May 28, 2003 | Start Trial | Start Trial |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-003 | Aug 15, 1988 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ESMOLOL HYDROCHLORIDE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 1368019 | Start Trial |
| European Patent Office | 2948379 | Start Trial |
| Denmark | 1368019 | Start Trial |
| Japan | 5778384 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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