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BREVIBLOC Drug Profile
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See Plans and PricingWhen do Brevibloc patents expire, and when can generic versions of Brevibloc launch?
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-six patent family members in twenty-four countries.
The generic ingredient in BREVIBLOC 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.
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: | 36 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 68 |
| 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 |
Recent Litigation for BREVIBLOC
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| BAXTER HEALTHCARE CORPORATION v. AGILA SPECIALTIES PRIVATE LIMITED | 2014-11-12 |
| BAXTER HEALTHCARE CORPORATION v. HQ SPECIALTY PHARMA CORPORATION | 2013-10-18 |
| BAXTER HEALTHCARE CORPORATION v. AGILA SPECIALTIES PRIVATE LIMITED |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2015-11-19 |
Pharmacology for BREVIBLOC
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Synonyms for BREVIBLOC
| (+-)-Methyl p-(2-hydroxy-3-(isopropylamino)propoxy)hydrocinnamate hydrochloride |
| (+/-)-methyl p-[2-hydroxy-3-(isopropylamino) propoxy]hydrocinnamate hydrochloride |
| 4-(2-Hydroxy-3-((1-methylethyl)amino)propoxy)benzenepropanoic acid methyl ester HCl |
| 4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]benxzenepropanoic Acid Methyl Ester Hydrochloride |
| 4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]benzenepropanoic acid methyl ester hydrochloride hydrochloride |
| 598E034 |
| 81147-92-4 (Parent) |
| 81161-17-3 |
| 81161-17-3, 81147-92-4(free base) |
| AB0013228 |
| AB07716 |
| AC-6972 |
| AC1L2XGQ |
| AC1Q3EA6 |
| AKOS015895316 |
| AN-9460 |
| API0001758 |
| Asl 8052 |
| ASL-8052 |
| BCP28434 |
| Benzenepropanoic acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, methyl ester, hydrochloride |
| Benzenepropanoic acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, methyl ester, hydrochloride, (+-)- |
| Benzenepropanoic acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, methyl ester,hydrochloride |
| BG0502 |
| Brevibloc (TN) |
| Brevibloc Double Strength in plastic container |
| Brevibloc in plastic container |
| C16H25NO4.HCl |
| CAS-81161-17-3 |
| CCG-100972 |
| CCG-220890 |
| CHEBI:4857 |
| CHEMBL1201115 |
| CPD000469141 |
| CS-4908 |
| CTK8F9497 |
| D00644 |
| DSSTox_CID_28929 |
| DSSTox_GSID_49003 |
| DSSTox_RID_83195 |
| DTXSID7049003 |
| EBD13377 |
| Esmolol (hydrochloride) |
| Esmolol HCL |
| Esmolol hydrochloride |
| Esmolol hydrochloride (JAN/USAN) |
| Esmolol hydrochloride [USAN] |
| Esmolol hydrochloride, >=98% (HPLC), solid |
| Esmolol hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Esmolol(hydrochloride) |
| FT-0082446 |
| FT-0601541 |
| H746 |
| HSDB 6530 |
| HY-B1392 |
| I06-0682 |
| J-003862 |
| KS-00001FBX |
| KS-1353 |
| LS-31122 |
| methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)propanoate hydrochloride |
| methyl 3-(4-{2-hydroxy-3-[(methylethyl)amino]propoxy}phenyl)propanoate, chlori de |
| METHYL 3-[4-(2-HYDROXY-3-PROPAN-2-YLAMINO-PROPOXY)PHENYL]PROPANOATE HYDROCHLORIDE |
| Methyl 3-[4-(2-hydroxy-3-propan-2-ylamino-propoxy)phenyl]propanoate hydrochloride; Brevibloc |
| methyl 3-[4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl]propanoate hydrochloride |
| methyl 3-[4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]propanoate hydrochloride |
| Methyl 3-{4-[2-Hydroxy-3-(isopropylamino)propoxy]phenyl}propanoate hydrochloride (Esmolol HCl) |
| MLS001401393 |
| MolPort-003-847-093 |
| NC00222 |
| NCGC00185766-01 |
| NCGC00185766-04 |
| Q-201070 |
| s4100 |
| SAM001246533 |
| SBB055181 |
| SCHEMBL41086 |
| SMR000469141 |
| SR-01000763706 |
| SR-01000763706-4 |
| SW197602-3 |
| TL8005428 |
| Tox21_113496 |
| Tox21_113496_1 |
| W-1240 |
Paragraph IV (Patent) Challenges for BREVIBLOC
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BREVIBLOC IN PLASTIC CONTAINER | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
| BREVIBLOC | INJECTABLE;INJECTION | esmolol hydrochloride | 019386 | 2014-01-31 |
| BREVIBLOC DOUBLE STRENGTH 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 | |||
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-006 | Feb 25, 2003 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Baxter Hlthcare | BREVIBLOC | esmolol hydrochloride | INJECTABLE;INJECTION | 019386-006 | Feb 25, 2003 | AP | 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 | 019386-003 | 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 | 019386-007 | 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 | 019386-003 | 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 |
|---|---|---|
| Slovenia | 1368019 | Start Trial |
| Czech Republic | 20023825 | Start Trial |
| Portugal | 1368019 | Start Trial |
| Japan | 2004519506 | Start Trial |
| Poland | 357387 | Start Trial |
| China | 1981739 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
