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Baxter
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Fuji
Citi
UBS
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Generated: September 26, 2017

DrugPatentWatch Database Preview

Bupivacaine - Generic Drug Details

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What are the generic drug sources for bupivacaine and what is the scope of bupivacaine patent protection?

Bupivacaine
is the generic ingredient in thirteen branded drugs marketed by Pacira Pharms Inc, Fresenius Kabi Usa, Sagent Agila, Hospira, Intl Medicated, Baxter Hlthcare Corp, Aurobindo Pharma Ltd, Septodont, and Amphastar Pharms Inc, and is included in thirty-eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has thirty-nine patent family members in fifteen countries.

There are ten drug master file entries for bupivacaine. One supplier is listed for this compound.

Summary for Generic Name: bupivacaine

Tradenames:13
Patents:4
Applicants:9
NDAs:38
Drug Master File Entries: see list10
Suppliers / Packagers: see list1
Bulk Api Vendors: see list62
Clinical Trials: see list770
Patent Applications: see list10,746
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bupivacaine at DailyMed

Pharmacology for Ingredient: bupivacaine

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-002Oct 28, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Sagent Agila
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION091487-002Oct 18, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
MARCAINE
bupivacaine hydrochloride
INJECTABLE;SPINAL018692-001May 4, 1984APRXYesYes► Subscribe► Subscribe► Subscribe
Hospira
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
bupivacaine hydrochloride; epinephrine
INJECTABLE;INJECTION071167-001Jun 16, 1988RXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION203895-003Nov 5, 2013APRXNoNo► Subscribe► Subscribe► Subscribe
Intl Medicated
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION076012-002Jan 9, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Sagent Agila
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION091487-001Oct 18, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
SENSORCAINE
bupivacaine hydrochloride
INJECTABLE;INJECTION018304-002Approved Prior to Jan 1, 1982APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION016964-009Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
SENSORCAINE
bupivacaine hydrochloride; epinephrine bitartrate
INJECTABLE;INJECTION070968-001Oct 13, 1987APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: bupivacaine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-001Oct 28, 2011► Subscribe► Subscribe
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-002Oct 28, 2011► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: bupivacaine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,045,824 Sustained-release liposomal anesthetic compositions► Subscribe
9,192,575Sustained-release liposomal anesthetic compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bupivacaine

Country Document Number Estimated Expiration
Australia2008203032► Subscribe
Spain2343767► Subscribe
World Intellectual Property Organization (WIPO)9913865► Subscribe
Austria554748► Subscribe
European Patent Office1014946► Subscribe
Australia2006200044► Subscribe
Canada2304096► Subscribe
Israel135060► Subscribe
Australia2015200303► Subscribe
Austria463238► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Accenture
Boehringer Ingelheim
Deloitte
Covington
Fuji
Citi
Novartis
Johnson and Johnson
Express Scripts
Mallinckrodt

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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