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EXPAREL Drug Profile

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Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug.

This drug has twenty patent family members in fifteen countries.

The generic ingredient in EXPAREL is bupivacaine. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupivacaine profile page.

Summary for Tradename: EXPAREL

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: EXPAREL

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

Clinical Trials for: EXPAREL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-001Oct 28, 2011DISCNNo8,182,835<disabled>Y <disabled>
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-002Oct 28, 2011RXYes8,834,921<disabled>Y <disabled>
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-001Oct 28, 2011DISCNNo8,834,921<disabled>Y <disabled>
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Expired Patents for Tradename: EXPAREL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-001Oct 28, 20116,132,766<disabled>
Pacira Pharms Inc
EXPAREL
bupivacaine
INJECTABLE, LIPOSOMAL;INJECTION022496-002Oct 28, 20116,132,766<disabled>
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Non-Orange Book Patents for Tradename: EXPAREL

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<disabled in preview>
9,192,575Sustained-release liposomal anesthetic compositions<disabled in preview>
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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 Tradename: EXPAREL

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9913865<disabled in preview>
European Patent Office2198854<disabled in preview>
Japan4467789<disabled in preview>
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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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