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Generated: January 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022496

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NDA 022496 describes EXPAREL, which is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the EXPAREL profile page.

The generic ingredient in EXPAREL is bupivacaine. There are twelve 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 022496
Tradename:EXPAREL
Applicant:Pacira Pharms Inc
Ingredient:bupivacaine
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022496
Generic Entry Date for 022496*:
Constraining patent/regulatory exclusivity:
REVISION OF THE INDICATION SECTION OF THE PACKAGE INSERT REGARDING AN INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
Dosage:
INJECTABLE, LIPOSOMAL;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022496
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 022496
Suppliers and Packaging for NDA: 022496
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496 NDA Pacira Pharmaceuticals Inc. 65250-133 65250-133-04 4 VIAL in 1 CARTON (65250-133-04) > 10 mL in 1 VIAL (65250-133-10)
EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496 NDA Pacira Pharmaceuticals Inc. 65250-133 65250-133-09 10 VIAL in 1 CARTON (65250-133-09) > 10 mL in 1 VIAL (65250-133-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INJECTIONStrength133MG/10ML (13.3MG/ML)
Approval Date:Oct 28, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 6, 2021
Regulatory Exclusivity Use:REVISION OF THE INDICATION SECTION OF THE PACKAGE INSERT REGARDING AN INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
Patent:➤ Sign UpPatent Expiration:Sep 18, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:SINGLE DOSE ADMINISTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL ANALGESIA
Patent:➤ Sign UpPatent Expiration:Sep 18, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:SINGLE-DOSE INFILTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL ANALGESIA.

Expired US Patents for NDA 022496

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ➤ Sign Up ➤ Sign Up
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 ➤ Sign Up ➤ Sign Up
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ➤ Sign Up ➤ Sign Up
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 ➤ Sign Up ➤ Sign Up
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Baxter
Farmers Insurance
Harvard Business School
Teva
Dow
Colorcon
Accenture

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