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BREVIBLOC IN PLASTIC CONTAINER Drug Profile
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» See Plans and PricingWhen do Brevibloc In Plastic Container patents expire, and when can generic versions of Brevibloc In Plastic Container launch?
Brevibloc In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA. There are two patents protecting this drug.
This drug has thirty-eight patent family members in twenty-five countries.
The generic ingredient in BREVIBLOC 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 Brevibloc In Plastic Container
A generic version of BREVIBLOC IN PLASTIC CONTAINER was approved as esmolol hydrochloride by WEST-WARD PHARMS INT on August 10th, 2004.
Summary for BREVIBLOC IN PLASTIC CONTAINER
| International Patents: | 38 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 16 |
| Patent Applications: | 620 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | BREVIBLOC IN PLASTIC CONTAINER at DailyMed |
Recent Clinical Trials for BREVIBLOC IN PLASTIC CONTAINER
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 IN PLASTIC CONTAINER
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Paragraph IV (Patent) Challenges for BREVIBLOC IN PLASTIC CONTAINER
| 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 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| 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 IN PLASTIC CONTAINER
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BREVIBLOC IN PLASTIC CONTAINER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 546424 | Start Trial |
| Japan | 2004519506 | Start Trial |
| World Intellectual Property Organization (WIPO) | 02076446 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
