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Generated: December 12, 2017

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Esmolol hydrochloride - Generic Drug Details

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What are the generic drug sources for esmolol hydrochloride and what is the scope of esmolol hydrochloride freedom to operate?

Esmolol hydrochloride
is the generic ingredient in six branded drugs marketed by Baxter Hlthcare, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Luitpold Pharms Inc, Mylan Institutional, West-ward Pharms Int, and Hq Spclt Pharma, and is included in seven 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-three patent family members in twenty-five countries.

There are eight drug master file entries for esmolol hydrochloride. Eleven suppliers are listed for this compound.

Pharmacology for esmolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Baxter HlthcareBREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINEResmolol hydrochlorideINJECTABLE;INJECTION019386-005Jan 27, 2003RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Baxter HlthcareBREVIBLOCesmolol hydrochlorideINJECTABLE;INJECTION019386-006Feb 25, 2003APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Baxter HlthcareBREVIBLOC IN PLASTIC CONTAINEResmolol hydrochlorideINJECTABLE;INJECTION019386-004Feb 16, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Baxter HlthcareBREVIBLOCesmolol hydrochlorideINJECTABLE;INJECTION019386-006Feb 25, 2003APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan InstitutionalESMOLOL HYDROCHLORIDEesmolol hydrochlorideINJECTABLE;INJECTION076474-001May 2, 2005APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hq Spclt PharmaESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINEResmolol hydrochlorideSOLUTION;INTRAVENOUS205703-001Apr 7, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Luitpold Pharms IncESMOLOL HYDROCHLORIDEesmolol hydrochlorideINJECTABLE;INJECTION201126-001Feb 20, 2015APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hq Spclt PharmaESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINEResmolol hydrochlorideSOLUTION;INTRAVENOUS205703-002Apr 7, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Baxter HlthcareBREVIBLOCesmolol hydrochlorideINJECTABLE;INJECTION019386-003Aug 15, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hq Spclt PharmaESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINEResmolol hydrochlorideSOLUTION;INTRAVENOUS205703-001Apr 7, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: esmolol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter HlthcareBREVIBLOCesmolol hydrochlorideINJECTABLE;INJECTION019386-003Aug 15, 1988► Subscribe► Subscribe
Baxter HlthcareBREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINEResmolol hydrochlorideINJECTABLE;INJECTION019386-005Jan 27, 2003► Subscribe► Subscribe
Baxter HlthcareBREVIBLOCesmolol hydrochlorideINJECTABLE;INJECTION019386-007May 28, 2003► Subscribe► Subscribe
Baxter HlthcareBREVIBLOCesmolol hydrochlorideINJECTABLE;INJECTION019386-006Feb 25, 2003► Subscribe► Subscribe
Baxter HlthcareBREVIBLOC IN PLASTIC CONTAINEResmolol hydrochlorideINJECTABLE;INJECTION019386-004Feb 16, 2001► Subscribe► Subscribe
Baxter HlthcareBREVIBLOCesmolol hydrochlorideINJECTABLE;INJECTION019386-003Aug 15, 1988► Subscribe► Subscribe
Baxter HlthcareBREVIBLOCesmolol hydrochlorideINJECTABLE;INJECTION019386-003Aug 15, 1988► Subscribe► Subscribe
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International Patent Family for Ingredient: esmolol hydrochloride

Country Document Number Estimated Expiration
Canada2410446► Subscribe
European Patent Office1738756► Subscribe
TaiwanI277414► Subscribe
Japan5778384► Subscribe
Argentina098013► Subscribe
Slovakia288113► Subscribe
South Africa200206688► Subscribe
China1455669► Subscribe
Hungary0204520► Subscribe
Austria341319► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Medtronic
Federal Trade Commission
Boehringer Ingelheim
Baxter
McKinsey
Moodys
Deloitte
Fish and Richardson
McKesson

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 verifification 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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