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BREVIBLOC Drug Profile
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» See Plans and PricingWhen do Brevibloc patents expire, and what generic alternatives are available?
Brevibloc is a drug marketed by Baxter Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-eight patent family members in twenty-five countries.
The generic ingredient in BREVIBLOC 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 Brevibloc
A generic version of BREVIBLOC was approved as esmolol hydrochloride by WEST-WARD PHARMS INT on August 10th, 2004.
Summary for BREVIBLOC
| International Patents: | 38 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 16 |
| Patent Applications: | 610 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BREVIBLOC |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BREVIBLOC |
| DailyMed Link: | BREVIBLOC at DailyMed |
Recent Clinical Trials for BREVIBLOC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zagazig University | Phase 2 |
| Cristália Produtos Químicos Farmacêuticos Ltda. | Phase 4 |
| University Hospital Bispebjerg and Frederiksberg | Phase 4 |
Pharmacology for BREVIBLOC
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Paragraph IV (Patent) Challenges for BREVIBLOC
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BREVIBLOC | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
| 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 |
US Patents and Regulatory Information for BREVIBLOC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-003 | Aug 15, 1988 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Baxter Hlthcare | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-005 | Jan 27, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-007 | May 28, 2003 | DISCN | No | No | 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 BREVIBLOC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-006 | Feb 25, 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 BREVIBLOC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 546424 | Start Trial |
| Japan | 2004519506 | Start Trial |
| World Intellectual Property Organization (WIPO) | 02076446 | Start Trial |
| Czech Republic | 304290 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
